Effectiveness of a Fully Automated Internet-Based Smoking Cessation Program: A Randomized Controlled Trial (STAMP)

Effectiveness of a Fully Automated Internet-Based Smoking Cessation Program: A Randomized... Abstract Introduction The Internet offers an interesting alternative to face-to-face and telephone-based support for smoking cessation. This study was designed to assess the effectiveness of a personalized and automated Internet-based program. Methods French current adult smokers willing to quit within 2 weeks were recruited for a randomized controlled trial. The intervention consisted of an automated program of 45 e-mails (“e-coaching”) sent over a 3-month period. The control group received a PDF version of a booklet on smoking cessation. Self-reported 7-day point prevalence smoking abstinence was measured at 6 months (primary outcome), at 3 and 12 months of follow-up (secondary outcomes). Results 2478 smokers were randomized (1242 for e-coaching, 1236 for the booklet). Cessation rate in the intention-to-treat population was not significantly different between the two groups at 6 and 12 months, but was higher in the e-coaching group at 3 months than in the control group (27.5% vs. 23.5%, p = .02, odds ratio [OR] = 1.24, confidence interval [CI] = [1.03–1.49]). After adjustment for baseline conditions, the effect of the intervention in the per-protocol (PP) sample was significant at 3 months (adjusted odds ratio [aOR] = 1.72 [1.31–2.28], p < .001, N = 1042) and at 6 months (aOR = 1.27 [1.00–1.60], p = .05, N = 1082). GLM repeated measure analyses showed significant group by time interaction in the intent-to-treat and a significant group effect in the PP population. Conclusions Analyzed intention-to-treat, e-coaching was superior to a booklet at 3 months (end of intervention) but no more superior at 6 and 12 months follow-up. Among those who actually followed the program, the effectiveness is also observed 3 months after the intervention is stopped. Implications Analyzed intention-to-treat, our French tailored and personalized Internet-based cessation program was superior to a smoking cessation booklet at 3 months (end of intervention) but no more superior at 6 months follow-up. Among those who actually followed the program (PP population), the effectiveness is observed in the short-term but also 3 months after the intervention is stopped. Introduction Given the huge burden of diseases attributed to tobacco use, it is crucial to develop effective smoking cessation interventions to help smokers quit. Smoking cessation aids like pharmacotherapy, telephone, and face-to-face counseling, are expensive and resource-demanding. The Internet offers an interesting alternative to the latter strategies. In particular, automated programs are resource-saving, as their costs are effectively limited to program development, and accessing them is not limited by opening hours.1–4 Research has focused on the effectiveness of these types of interventions for more than a decade.2–12 In a recent review of 40 randomized trials published between 1990 and 2015 (98530 participants included), the authors concluded that the efficacy of Internet interventions is superior to print materials and equivalent to face-to-face counseling and telephone interventions.13 Web-based programs may help achieve long-term smoking cessation under specific conditions, particularly when they are intensive, interactive and tailored to individuals.14 It is crucial to describe precisely the intervention in order to identify the active components associated with its effectiveness. Taking into account findings from the literature, a personalized and fully automated Internet-based cessation program (hereafter referred to as e-coaching) was developed for French-speaking smokers in 2009. The STAMP (Sevrage Tabagique Assisté par Mailing Personnalisé) study was designed to assess the effectiveness of this program, and its results are reported in this article. Methods Hypothesis Our hypothesis was that the e-coaching would lead to higher abstinence rates than a self-help booklet at 6 months of follow-up (primary outcome), at 3 months (end of the intervention) and 12 months of follow-up (secondary outcomes).7–12,14,15 Trial Design The STAMP study was a two-arm randomized controlled trial that compared a fully automated, web-based smoking cessation program with a downloadable 30-page self-help booklet. Participants The enrollment period extended from March to November 2010. Participants were recruited directly from among the visitors of the national website (“tabac-info-service.fr”). No specific announcement or advertising was created for the study recruitment, to avoid the risk of attracting smokers whose profile differed from that of usual visitors of the website. Smokers who clicked on the banner which read “Get some help to quit smoking” were directed to the recruitment website created specifically for this study. The study protocol was approved by the institutional review board (IRB) of the Pitié Salpétrière Hospital (Comité de protection des personnes Ile de France 6) in January 2010. In accordance with the International committee of medical journal editors (ICMJE) requirements, the STAMP study was registered prospectively before recruitment of the participants. ClinicalTrials.gov identifier: NCT01073085. Recruitment The study website described the objectives and the stages of the study. It explained that a 12-month trial was being conducted to compare several types of smoking cessation help (no specific information was given on the types of help), and that if the visitor participated, he/she would be provided with one type of help and asked to answer four questionnaires sent by e-mail over the 12-month period. Those who completed the four questionnaires would receive a 10 € voucher, and five winners would be randomly drawn to receive a 500 € voucher. There was no restriction on the use of other smoking cessation strategies during the STAMP study. The eligibility criteria were: being 18 years or older, being a current cigarette smoker (manufactured or roll-your-own tobacco cigarettes), having a personal e-mail address, willing to quit within 2 weeks, and not having previously benefited from e-coaching. Eligible participants were asked to provide their informed consent to participate directly on the website. Those who received the baseline questionnaire were checked again to meet eligibility criteria. Baseline Questionnaire At baseline, all participants were asked to fill in a questionnaire16 about demographic characteristics (age, sex, educational level), Body Mass Index (BMI), alcohol consumption and smoking behaviors and attitudes: time before first cigarette in the morning, how long they had been smokers, number of previous quit attempts, duration of longest quit attempt, self-efficacy, motivation to quit, and whether they (1) planned to quit smoking cold turkey or gradually cutting down the number of cigarettes, (2) planned to use medications to quit, (3) planned to quit in the next 1 month or within 6 months. Three educational levels were considered: lower than high school, high school graduate, and higher education graduate. Alcohol consumption data were collected for the previous 7 days and respondents were recoded into the following categories: abstinent, not an at-risk alcohol user (less than 21 and 14 alcohol units per week for men and women, respectively), an at-risk alcohol user (more than 21 and 14 alcohol units per week for men and women, respectively). The level of tobacco dependence was assessed by the Heaviness of Smoking Index. Heaviness of Smoking Index was computed by taking the sum of two categorized measures: the number of cigarettes per day and time before smoking the first cigarette of the day. Heaviness of Smoking Index values ranged from 0 to 6 with higher values indicating stronger tobacco addiction: 0–1 weak tobacco dependence, 2–3 moderate tobacco dependence and 4–6 high tobacco dependence.17 Self-efficacy and motivation of the participants to quit were assessed by asking them to rate their level of self-confidence and motivation on a 0 to 10 scale.18 Participants were also asked to set a quit date, recommended to be within 2 weeks to allow for a period of preparation. Intervention E-coaching The intervention consisted of a fully automated program of about 45 e-mails over a period of about 3 and half months. Once a quit date had been chosen by the smoker, e-mails to prepare them for smoking cessation were sent during the 15 days before the date (seven e-mails). From the quit date, e-mails were sent over a 3-month period, initially with a high frequency which then decreased: one e-mail per day for the first week after quitting tobacco (seven e-mails), one e-mail every 2 days for 6 weeks (21 e-mails), then one e-mail every 4 days for the remaining 6 weeks (10 e-mails). No more e-mails were sent after these 3 months after the quit date. Developed by the French Institute for Health Promotion and Health Education (now Santé publique France, the national public health agency), this automated program (automatic sending of e-mails)—entitled e-coaching—was hosted by the governmental website dedicated to smoking cessation (www.tabac-info-service.fr), and was completely free of charge to users. The design of the program and the content of the e-mails were developed by smoking cessation treatment specialists. E-coaching is largely based on techniques inspired by motivational interviewing and cognitive behavioral therapy. The e-mails sent before the quit date provided information about the harms of smoking, advice on how to anticipate difficulties and develop coping strategies to face them, as well as exercises to enhance motivation. On the quit date, a series of e-mails were sent with congratulations, information about the health benefits already occurring, advice on how to maintain abstinence and how to manage relapses. The content is mainly text, with links to specific brochures, for example for nutrition advice. Registrants were divided into 14 profiles according to age, sex, level of tobacco dependence, motivation to quit, past quit attempts and a profile for pregnant women, according to the data collected at baseline (Table 1). The number and frequency of e-mails were mostly identical for all profiles. The content of the e-mails of all profiles was based on the stages of the theory of change.19 Specific contents was added according to user profiles, for example, a specific online pamphlet “Pregnancy and Tobacco” and specific advice were sent to pregnant women, content on tobacco-related representations was sent to young people to act on the image of cigarettes, more specific nutrition advice was sent to women aged 19–35 to avoid weight gain, more advice for managing nicotine withdrawal and the use of nicotine replacement therapies were directed to heavily dependent smokers. Table 1. Fourteen Profiles of E-coaching Young    Profile 1  Young 18 years old or younger, with weak or moderate tobacco dependencea  Profile 2  Young 18 years old or younger, with high tobacco dependencea  Pregnant woman  Profile 3  Pregnant woman or planning pregnancy  19–50 ans (except profiles 10 and 11)  Profile 4  19–50 years with high tobacco dependence, little or moderately motivated, first attempt to quit smoking  Profile 5  19–50 years with high tobacco dependence, little or moderately motivated, new attempt to quit smoking  Profile 6  19–50 years with high tobacco dependence, very motivated, new attempt to quit smoking  Profile 7  19–50 years with high tobacco dependence, very motivated, first attempt to quit smoking  Profile 8  19–50 years with moderate tobacco dependence, little or moderately motivated  Profile 9  19–50 years with moderate tobacco dependence, very motivated  Woman 19–35 years  Profile 10  Female 19–35 years with weak tobacco dependence, little or moderately motivated  Profile 11  Female 19–35 years with moderate tobacco dependence, little motivated  Over 50 years  Profile 12  Man or woman over 50, with weak or moderate tobacco dependence, little or moderately motivated, first quit attempt  Profile 13  Man or woman over 50 with high tobacco dependence, moderately or very motivated, new attempt to quit smoking  Others  Profile 14  All smokers who do not match other profiles  Young    Profile 1  Young 18 years old or younger, with weak or moderate tobacco dependencea  Profile 2  Young 18 years old or younger, with high tobacco dependencea  Pregnant woman  Profile 3  Pregnant woman or planning pregnancy  19–50 ans (except profiles 10 and 11)  Profile 4  19–50 years with high tobacco dependence, little or moderately motivated, first attempt to quit smoking  Profile 5  19–50 years with high tobacco dependence, little or moderately motivated, new attempt to quit smoking  Profile 6  19–50 years with high tobacco dependence, very motivated, new attempt to quit smoking  Profile 7  19–50 years with high tobacco dependence, very motivated, first attempt to quit smoking  Profile 8  19–50 years with moderate tobacco dependence, little or moderately motivated  Profile 9  19–50 years with moderate tobacco dependence, very motivated  Woman 19–35 years  Profile 10  Female 19–35 years with weak tobacco dependence, little or moderately motivated  Profile 11  Female 19–35 years with moderate tobacco dependence, little motivated  Over 50 years  Profile 12  Man or woman over 50, with weak or moderate tobacco dependence, little or moderately motivated, first quit attempt  Profile 13  Man or woman over 50 with high tobacco dependence, moderately or very motivated, new attempt to quit smoking  Others  Profile 14  All smokers who do not match other profiles  HSI = Heaviness of Smoking Index. aHigh tobacco dependence: HSI 4 to 6; Moderate tobacco dependence: HSI 2 or 3; Weak tobacco dependence: HSI 0 or 1. View Large Table 1. Fourteen Profiles of E-coaching Young    Profile 1  Young 18 years old or younger, with weak or moderate tobacco dependencea  Profile 2  Young 18 years old or younger, with high tobacco dependencea  Pregnant woman  Profile 3  Pregnant woman or planning pregnancy  19–50 ans (except profiles 10 and 11)  Profile 4  19–50 years with high tobacco dependence, little or moderately motivated, first attempt to quit smoking  Profile 5  19–50 years with high tobacco dependence, little or moderately motivated, new attempt to quit smoking  Profile 6  19–50 years with high tobacco dependence, very motivated, new attempt to quit smoking  Profile 7  19–50 years with high tobacco dependence, very motivated, first attempt to quit smoking  Profile 8  19–50 years with moderate tobacco dependence, little or moderately motivated  Profile 9  19–50 years with moderate tobacco dependence, very motivated  Woman 19–35 years  Profile 10  Female 19–35 years with weak tobacco dependence, little or moderately motivated  Profile 11  Female 19–35 years with moderate tobacco dependence, little motivated  Over 50 years  Profile 12  Man or woman over 50, with weak or moderate tobacco dependence, little or moderately motivated, first quit attempt  Profile 13  Man or woman over 50 with high tobacco dependence, moderately or very motivated, new attempt to quit smoking  Others  Profile 14  All smokers who do not match other profiles  Young    Profile 1  Young 18 years old or younger, with weak or moderate tobacco dependencea  Profile 2  Young 18 years old or younger, with high tobacco dependencea  Pregnant woman  Profile 3  Pregnant woman or planning pregnancy  19–50 ans (except profiles 10 and 11)  Profile 4  19–50 years with high tobacco dependence, little or moderately motivated, first attempt to quit smoking  Profile 5  19–50 years with high tobacco dependence, little or moderately motivated, new attempt to quit smoking  Profile 6  19–50 years with high tobacco dependence, very motivated, new attempt to quit smoking  Profile 7  19–50 years with high tobacco dependence, very motivated, first attempt to quit smoking  Profile 8  19–50 years with moderate tobacco dependence, little or moderately motivated  Profile 9  19–50 years with moderate tobacco dependence, very motivated  Woman 19–35 years  Profile 10  Female 19–35 years with weak tobacco dependence, little or moderately motivated  Profile 11  Female 19–35 years with moderate tobacco dependence, little motivated  Over 50 years  Profile 12  Man or woman over 50, with weak or moderate tobacco dependence, little or moderately motivated, first quit attempt  Profile 13  Man or woman over 50 with high tobacco dependence, moderately or very motivated, new attempt to quit smoking  Others  Profile 14  All smokers who do not match other profiles  HSI = Heaviness of Smoking Index. aHigh tobacco dependence: HSI 4 to 6; Moderate tobacco dependence: HSI 2 or 3; Weak tobacco dependence: HSI 0 or 1. View Large Control Participants in the control group received a PDF version of a 30-page booklet entitled “J’arrête de fumer” (“I quit smoking”). Like e-coaching, this self-help tool was developed by the French Institute for Health Promotion and Health Education and is available free of charge online.20 The booklet is structured on the stages of change theory,19 like e-coaching, with four chapters: “I smoke,” “I hesitate over quitting,” “I have decided to quit,” and “I quit”. Each chapter contains information, exercises and advice related to the current stage of change in the smoker’s behavior. Randomization Based on computer-generated random digits, eligible participants who fully completed the baseline questionnaire were randomly allocated to either receive the automated intervention (e-coaching group) or the booklet (booklet group) with a 1:1 allocation ratio. After randomization, each participant received an e-mail with either a link to the e-coaching registration page or to a PDF version of the smoking cessation booklet. Sample Size The sample size calculation was based on an estimated 5% abstinence rate in the control group at 6 months15 and a hypothesized increase of four points in the e-coaching group compared to the control group, with an alpha = 0.05 for type I error and 1-beta = 0.20 (type II error), using Casagrande and Pike formula.21 Assuming an attrition rate of 40%, 1150 participants per group were required. Outcomes Web-based questionnaires were sent 3, 6, and 12 months after inclusion in the study.16 An e-mail was sent with a link to the questionnaire, and two subsequent e-mail reminders were sent 4 and 10 days later to nonrespondents. The primary outcome was self-reported 7-day point prevalence smoking abstinence at 6 months of follow-up. Secondary outcomes were 7-day point prevalence smoking abstinence at 3 and 12 months of follow-up. Use of the allocated assistance (e-coaching or booklet) was also evaluated with the question “To what extent did you read/use the e-mails (e-coaching group) / the booklet (booklet group) you received.” Data Management and Statistical Methods Data Management To measure abstinence, the participants at the 3, 6, and 12-month follow-ups were asked if they were current smokers. Those who responded “no” were then asked how long they had been abstinent. This method of measuring abstinence allowed to assess the general consistency of the data set: for example, a participant who declared he/she had been abstinent for 4 months on the 6-month questionnaire would have also declared being abstinent for 1 month on the 3-month questionnaire. More importantly, this method allowed to partly compensate for the attrition at 3 and 6 months of follow-up by using later surveys: for example, if a participant did not respond to our 3-month survey but reported that he/she had been abstinent for (at least) 97 days at 6 months of follow-up, it was consequently deduced that he/she was 7-day point prevalence smoking abstinent at 3 months. At the end of data collection, the data set was checked and completed following these same principles. Statistical Methods To compare the two groups (e-coaching vs. control) on sociodemographic characteristics and baseline measurements, Pearson’s chi-square test and Student’s t test were used for categorical and continuous variables, respectively. The primary analysis was the conservative intent-to-treat (ITT) method, where data from all randomized participants were analyzed and non-respondents or missing values considered as smokers. The secondary analyses were per-protocol (PP) analyses: only participants for whom at least one abstinence datum was available and who had followed the proposed protocol were included: in the e-coaching group participants had to have read the e-mails “systematically” or “often,” and in the booklet group they had to have read the booklet “entirely” or “partially”. Thus, analyses were not limited to respondents’ data in either the ITT or PP analyses, as some abstinence data could be recovered from later survey waves for non-respondents (see “data management” section). To evaluate the effects of the intervention on abstinence, cessation rates were compared between the e-coaching and the booklet group, at each time point separately (3, 6 and 12 months) using Pearson’s chi-square test for unpaired data. Crude odds ratios (ORs) were also estimated for each comparison. Then logistic regressions on data from the PP population were used to estimate the effects among people who actually followed the intervention, by controlling for potential confounders at baseline. Confounders were chosen by a two-steps method: first, sociodemographic and baseline characteristics variables were selected from the global PP (test between the two groups e-coaching vs. control with p value < .1). Then, these selected variables were tested again between the two groups on the PP populations at each time (subjects from the PP available at 3, 6, or 12 months). Logistic regression models were conducted to explain the abstinence at each time, incorporating the group (variable of interest) as well as the previously selected confounders. Adjusted odds-ratios (aORs) and their 95% confidence intervals (95% CIs) were estimated from these final models. Finally, repeated measures analyses were performed using a Generalized Linear Mixed Models for binary data (SAS Glimmix Procedure) with the group and the time as fixed effects, the subject as random effect. The interaction between the group and the time was also tested. This analysis was performed without adjustment in the ITT population. It was performed without and with adjustment on previously determined confounders in the PP population. Results Recruitment During the 9-month recruitment period, 330000 people visited the website; 45335 clicked on the “Get some help to quit smoking” banner; 15412 began completing the screening questionnaire; 4724 were eligible, and 2478 gave their informed consent and were finally randomized (1242 in the e-coaching group and 1236 in the booklet group). Randomization was stopped when the predetermined sample size was reached. Following the CONSORT recommendations, we depicted the flow of participants for each step of the study (Figure 1). Participation rates at each follow-up ranged between 52.3% and 58.7%. Figure 1. View largeDownload slide Flow of study participants. By definition, the intention-to-treat (ITT) population is the same at each time-point. The number of participants with smoking status at 3 and 6 months takes into account the data collected in subsequent waves (see “Data management” section). Figure 1. View largeDownload slide Flow of study participants. By definition, the intention-to-treat (ITT) population is the same at each time-point. The number of participants with smoking status at 3 and 6 months takes into account the data collected in subsequent waves (see “Data management” section). Baseline Data Table 2 presents the sociodemographic and smoking-related characteristics at baseline for the two groups. 1607 of the 2478 participants (64.8%) were female. The age of the respondents ranged from 18 to 77 years, and the mean age was 36 (SD 9.8) years. Four hundred ninety-five persons (20.0%) had an educational level lower than high school diploma, 410 (16.5%) had a high school diploma, and 1573 (63.5%) had a higher level of education. Table 2. Sociodemographic and Smoking-Related Characteristics at Baseline for the Two Groups   Total randomized (N = 2478)  Intervention group (N = 1242): e-coaching  Control group (N = 1236): booklet    n  %  n  %  n  %  p value for difference  Sex   Male  871  35.2  426  34.3  445  36.0  .374   Female  1607  64.8  816  65.7  791  64.0    Age (years)   18–24  286  11.5  126  10.1  160  12.9  .086   25–39  1429  57.7  725  58.4  704  57.0     40–54  662  26.7  333  26.8  329  26.6     ≥55  101  4.1  58  4.7  43  3.5    Mean age (SD)  35.9 (9.8)    36.2 (9.8)    35.6 (9.7)    .133  Education   Lower than high school  495  20.0  246  19.8  249  20.2  .205   High school completed  410  16.5  190  15.3  220  17.8     Higher education graduate  1573  63.5  806  64.9  767  62.1    Tobacco dependence (HSI)   0–1 (low)  684  27.6  358  28.9  326  26.4  .317   2–3 (moderate)  1139  46.0  568  45.8  571  46.2     4–6 (high)  653  26.4  315  25.4  338  27.4    Previous quit attempts (yes)    1976  79.7  996  80.2  980  79.3  .575  Self-efficacy in quitting   0–1 (low)  121  4.9  56  4.5  65  5.3  .283   2–5  1114  45.0  557  44.9  557  45.1     6–8  1006  40.6  521  42.0  485  39.2     9–10 (high)  237  9.6  108  8.7  129  10.4    Motivation to quit   0–5 (low)  138  5.6  58  4.7  80  6.5  .132   6–8  916  37.0  469  37.8  447  36.2     9–10 (high)  1424  57.5  715  57.6  709  57.4      Total randomized (N = 2478)  Intervention group (N = 1242): e-coaching  Control group (N = 1236): booklet    n  %  n  %  n  %  p value for difference  Sex   Male  871  35.2  426  34.3  445  36.0  .374   Female  1607  64.8  816  65.7  791  64.0    Age (years)   18–24  286  11.5  126  10.1  160  12.9  .086   25–39  1429  57.7  725  58.4  704  57.0     40–54  662  26.7  333  26.8  329  26.6     ≥55  101  4.1  58  4.7  43  3.5    Mean age (SD)  35.9 (9.8)    36.2 (9.8)    35.6 (9.7)    .133  Education   Lower than high school  495  20.0  246  19.8  249  20.2  .205   High school completed  410  16.5  190  15.3  220  17.8     Higher education graduate  1573  63.5  806  64.9  767  62.1    Tobacco dependence (HSI)   0–1 (low)  684  27.6  358  28.9  326  26.4  .317   2–3 (moderate)  1139  46.0  568  45.8  571  46.2     4–6 (high)  653  26.4  315  25.4  338  27.4    Previous quit attempts (yes)    1976  79.7  996  80.2  980  79.3  .575  Self-efficacy in quitting   0–1 (low)  121  4.9  56  4.5  65  5.3  .283   2–5  1114  45.0  557  44.9  557  45.1     6–8  1006  40.6  521  42.0  485  39.2     9–10 (high)  237  9.6  108  8.7  129  10.4    Motivation to quit   0–5 (low)  138  5.6  58  4.7  80  6.5  .132   6–8  916  37.0  469  37.8  447  36.2     9–10 (high)  1424  57.5  715  57.6  709  57.4    HSI = Heaviness of Smoking Index. View Large Table 2. Sociodemographic and Smoking-Related Characteristics at Baseline for the Two Groups   Total randomized (N = 2478)  Intervention group (N = 1242): e-coaching  Control group (N = 1236): booklet    n  %  n  %  n  %  p value for difference  Sex   Male  871  35.2  426  34.3  445  36.0  .374   Female  1607  64.8  816  65.7  791  64.0    Age (years)   18–24  286  11.5  126  10.1  160  12.9  .086   25–39  1429  57.7  725  58.4  704  57.0     40–54  662  26.7  333  26.8  329  26.6     ≥55  101  4.1  58  4.7  43  3.5    Mean age (SD)  35.9 (9.8)    36.2 (9.8)    35.6 (9.7)    .133  Education   Lower than high school  495  20.0  246  19.8  249  20.2  .205   High school completed  410  16.5  190  15.3  220  17.8     Higher education graduate  1573  63.5  806  64.9  767  62.1    Tobacco dependence (HSI)   0–1 (low)  684  27.6  358  28.9  326  26.4  .317   2–3 (moderate)  1139  46.0  568  45.8  571  46.2     4–6 (high)  653  26.4  315  25.4  338  27.4    Previous quit attempts (yes)    1976  79.7  996  80.2  980  79.3  .575  Self-efficacy in quitting   0–1 (low)  121  4.9  56  4.5  65  5.3  .283   2–5  1114  45.0  557  44.9  557  45.1     6–8  1006  40.6  521  42.0  485  39.2     9–10 (high)  237  9.6  108  8.7  129  10.4    Motivation to quit   0–5 (low)  138  5.6  58  4.7  80  6.5  .132   6–8  916  37.0  469  37.8  447  36.2     9–10 (high)  1424  57.5  715  57.6  709  57.4      Total randomized (N = 2478)  Intervention group (N = 1242): e-coaching  Control group (N = 1236): booklet    n  %  n  %  n  %  p value for difference  Sex   Male  871  35.2  426  34.3  445  36.0  .374   Female  1607  64.8  816  65.7  791  64.0    Age (years)   18–24  286  11.5  126  10.1  160  12.9  .086   25–39  1429  57.7  725  58.4  704  57.0     40–54  662  26.7  333  26.8  329  26.6     ≥55  101  4.1  58  4.7  43  3.5    Mean age (SD)  35.9 (9.8)    36.2 (9.8)    35.6 (9.7)    .133  Education   Lower than high school  495  20.0  246  19.8  249  20.2  .205   High school completed  410  16.5  190  15.3  220  17.8     Higher education graduate  1573  63.5  806  64.9  767  62.1    Tobacco dependence (HSI)   0–1 (low)  684  27.6  358  28.9  326  26.4  .317   2–3 (moderate)  1139  46.0  568  45.8  571  46.2     4–6 (high)  653  26.4  315  25.4  338  27.4    Previous quit attempts (yes)    1976  79.7  996  80.2  980  79.3  .575  Self-efficacy in quitting   0–1 (low)  121  4.9  56  4.5  65  5.3  .283   2–5  1114  45.0  557  44.9  557  45.1     6–8  1006  40.6  521  42.0  485  39.2     9–10 (high)  237  9.6  108  8.7  129  10.4    Motivation to quit   0–5 (low)  138  5.6  58  4.7  80  6.5  .132   6–8  916  37.0  469  37.8  447  36.2     9–10 (high)  1424  57.5  715  57.6  709  57.4    HSI = Heaviness of Smoking Index. View Large 2401 participants (96.9%) were daily smokers. On average, participants smoked 16 (SD 7.8) cigarettes per day, 653 (26.4%) were strongly dependent on tobacco (Heaviness of Smoking Index between 4 and 6) and 1976 (79.7%) had made previous quit attempts (7-day attempts or longer). 1243 participants (50.2%) rated their self-efficacy as greater than or equal to 6 (out of 10), and 2340 participants (94.4%) rated their motivation to quit as greater than or equal to 6 (out of 10). No significant difference was found (p > .05) between the two groups for the baseline measurements of socio-demographic data, smoking-related items, self-efficacy and motivation. Attrition Check The data management procedure enabled to recover data for 273 abstinence episodes at 3 months of follow-up (11.0% of the whole sample) and for 63 episodes at 6 months of follow-up (2.5% of the whole sample). It also helped us to spot six and two episodes of inconsistent data at 3 and 6 months of follow-up, respectively. These data were not corrected, in order to favor collected data over extrapolated data. Attrition Rate Analysis The participants without any follow-up (30.5%) were compared with those with at least one follow-up assessment. Attrition rate was higher among certain socio-demographic groups (p < .05): males (33.8% were lost-to-follow-up vs. 28.7% in females), smokers aged 18–25 (37.2% vs. 29.3% in smokers aged more than 25), students and unemployed smokers (respectively 36.0% and 37.9% vs. 28.5% in employed and 29.5% in retired smokers), smokers with a level of education lower than or equal to secondary (36.4% vs. 27.1% in college graduate). Attrition was also higher according to some characteristics of tobacco consumption (p < .05): a high dependence (35.1% vs. 30.3% for moderate dependence and 26.5% for low dependence), no quit attempt of at least a week in the past (36.9% vs. 28.8%), not planning to quit in the next month (36.3% vs. 28.6%) and not planning to use medication (33.7% vs. 27.5%). Outcomes and Estimation Cessation rates in the ITT population were significantly different between the two groups at 3 months (end of the intervention), but not at 6 and 12 months follow-ups (Table 3, Figure 2). The cessation rates at 3, 6, and 12 months were, respectively, 27.5% (e-coaching group, N = 342/1242) versus 23.5% (booklet group, N = 290/1236), 24.7% (N = 307/1242) versus 24.7% (N = 305/1236) and 20.9% (N = 259/1242) versus 20.6% (N = 254/1236). Repeated measures analysis showed a significant Group × Time interaction (p = .002) and a significant time effect (p < .001) (Table 5). Table 3. 7-Day Point Prevalence Smoking Abstinence at 3, 6, and 12 Months—Unadjusted Analysis Intent-to-treat analyses    E-coaching group N = 1242  Booklet group N = 1236  χ2  OR  df  Value  p  Value  95% CI  Cessation rate at 3 months  27.5% (N = 342)  23.5% (N = 290)  1  5.41  .02  1.24  [1.03–1.49]  Cessation rate at 6 months  24.7% (N = 307)  24.7% (N = 305)  1  0.001  .98  1.00  [0.83–1.20]  Cessation rate at 12 months  20.9% (N = 259)  20.6% (N = 254)  1  0.03  .85  1.02  [0.84–1.24]  Per protocol analyses        χ2  OR  E-coaching group  Booklet group  df  Value  p  Value  95% CI  Cessation rate at 3 months  48.9% (N = 295/603)  34.3% (N = 177/516)  1  24.37  <.001  1.83  [1.44–2.34]  Cessation rate at 6 months  46.1% (N = 265/575)  38.1% (N = 193/507)  1  7.10  .01  1.39  [1.09–1.77]  Cessation rate at 12 months   41.8% (N = 213/510)  37.0% (N = 164/443)  1  2.23  .14  1.22  [0.94–1.58]  Intent-to-treat analyses    E-coaching group N = 1242  Booklet group N = 1236  χ2  OR  df  Value  p  Value  95% CI  Cessation rate at 3 months  27.5% (N = 342)  23.5% (N = 290)  1  5.41  .02  1.24  [1.03–1.49]  Cessation rate at 6 months  24.7% (N = 307)  24.7% (N = 305)  1  0.001  .98  1.00  [0.83–1.20]  Cessation rate at 12 months  20.9% (N = 259)  20.6% (N = 254)  1  0.03  .85  1.02  [0.84–1.24]  Per protocol analyses        χ2  OR  E-coaching group  Booklet group  df  Value  p  Value  95% CI  Cessation rate at 3 months  48.9% (N = 295/603)  34.3% (N = 177/516)  1  24.37  <.001  1.83  [1.44–2.34]  Cessation rate at 6 months  46.1% (N = 265/575)  38.1% (N = 193/507)  1  7.10  .01  1.39  [1.09–1.77]  Cessation rate at 12 months   41.8% (N = 213/510)  37.0% (N = 164/443)  1  2.23  .14  1.22  [0.94–1.58]  df = degree of freedom; OR = unadjusted odds ratio; 95% CI = 95 % confidence intervals. View Large Table 3. 7-Day Point Prevalence Smoking Abstinence at 3, 6, and 12 Months—Unadjusted Analysis Intent-to-treat analyses    E-coaching group N = 1242  Booklet group N = 1236  χ2  OR  df  Value  p  Value  95% CI  Cessation rate at 3 months  27.5% (N = 342)  23.5% (N = 290)  1  5.41  .02  1.24  [1.03–1.49]  Cessation rate at 6 months  24.7% (N = 307)  24.7% (N = 305)  1  0.001  .98  1.00  [0.83–1.20]  Cessation rate at 12 months  20.9% (N = 259)  20.6% (N = 254)  1  0.03  .85  1.02  [0.84–1.24]  Per protocol analyses        χ2  OR  E-coaching group  Booklet group  df  Value  p  Value  95% CI  Cessation rate at 3 months  48.9% (N = 295/603)  34.3% (N = 177/516)  1  24.37  <.001  1.83  [1.44–2.34]  Cessation rate at 6 months  46.1% (N = 265/575)  38.1% (N = 193/507)  1  7.10  .01  1.39  [1.09–1.77]  Cessation rate at 12 months   41.8% (N = 213/510)  37.0% (N = 164/443)  1  2.23  .14  1.22  [0.94–1.58]  Intent-to-treat analyses    E-coaching group N = 1242  Booklet group N = 1236  χ2  OR  df  Value  p  Value  95% CI  Cessation rate at 3 months  27.5% (N = 342)  23.5% (N = 290)  1  5.41  .02  1.24  [1.03–1.49]  Cessation rate at 6 months  24.7% (N = 307)  24.7% (N = 305)  1  0.001  .98  1.00  [0.83–1.20]  Cessation rate at 12 months  20.9% (N = 259)  20.6% (N = 254)  1  0.03  .85  1.02  [0.84–1.24]  Per protocol analyses        χ2  OR  E-coaching group  Booklet group  df  Value  p  Value  95% CI  Cessation rate at 3 months  48.9% (N = 295/603)  34.3% (N = 177/516)  1  24.37  <.001  1.83  [1.44–2.34]  Cessation rate at 6 months  46.1% (N = 265/575)  38.1% (N = 193/507)  1  7.10  .01  1.39  [1.09–1.77]  Cessation rate at 12 months   41.8% (N = 213/510)  37.0% (N = 164/443)  1  2.23  .14  1.22  [0.94–1.58]  df = degree of freedom; OR = unadjusted odds ratio; 95% CI = 95 % confidence intervals. View Large Figure 2. View largeDownload slide Cessation rates at 3, 6, and 12 months. ITT: intention-to-treat population; PP: per protocol population. *p < .05, **p < .01, ***p < .001. Figure 2. View largeDownload slide Cessation rates at 3, 6, and 12 months. ITT: intention-to-treat population; PP: per protocol population. *p < .05, **p < .01, ***p < .001. Cessation rates in the PP population were significantly different between the two groups at 3 months and at 6, but not at 12 months (Table 3, Figure 2): cessation rates at 3, 6 and 12 months were, respectively, 48.9% (e-coaching group, N = 295/603) versus 34.3% (booklet group, N = 177/516), 46.1% (N = 265/575) versus 38.1% (N = 193/507) and 41.8% (N = 213/510) versus 37.0% (N = 164/443). After adjustment for baseline variables in the PP population (Table 4), the effect of e-coaching was significant at 3 months (aOR = 1.72 [1.31–2.28], p < .001, N = 1042) and at 6 months (aOR = 1.27 [1.00–1.60], p = .05, N = 1082). At 12 months, there was no significant difference: the adjusted odds-ratio was 1.11 [0.83–1.48] (p = .49, N = 953). Thus, the pattern of results from the logistic regression matches the pattern of results from the unadjusted analysis. Repeated measures analyses showed a significant group effect both without (p < .001) and with adjustment (p = .003), suggesting an overall higher cessation rate in the e-coaching than in the control group (Table 5). Table 4. 7-Day Point Prevalence Smoking Abstinence at 3, 6, and 12 Months—Per-Protocol Adjusted Analysis Per-protocol adjusted analysis at 3 months (N = 1042)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.9386  0.2171  79.7151  <.0001        Cessation rate at 3 months  1  0.2725  0.0708  14.8051  .0001  1.724  1.306  2.276  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1896  0.0344  30.3160  <.0001  1.209  1.130  1.293  Educational level (Higher education graduate / High school graduate and lower)  1  0.2185  0.0757  8.3345  .0039  1.548  1.151  2.083  Duration of longest quit attempta (>1 month / ≤1 month)  1  0.2232  0.0735  9.2214  .0024  1.563  1.172  2.085  Planned to quit smoking (Radical / Not radical)  1  0.2490  0.0847  8.6352  .0033  1.646  1.180  2.294  Quit date within 4 weeks (yes/no)  1  0.4060  0.1047  15.0284  .0001  2.252  1.494  3.396  Per-protocol adjusted analysis at 6 months (N = 1082)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −0.7287  0.0847  74.0246  <.0001      Cessation rate at 6 months  1  0.1176  0.0604  3.7928  .0515  1.265  0.998  1.603  Confounders  Educational level (Higher education graduate / High school graduate and lower)  1  0.2220  0.0645  11.8435  .0006  1.559  1.211  2.008  Planned to quit smoking (Radical / Not radical)  1  0.2317  0.0715  10.5191  .0012  1.590  1.201  2.103  Quit date within 4 weeks (Yes/No)  1  0.3858  0.0857  20.2460  <.0001  2.163  1.546  3.028  Per-protocol adjusted analysis at 12 months (N = 953)    Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.3556  0.2127  40.6059  <.0001      Cessation rate at 12 months  1  0.0508  0.0734  0.4786  .4891  1.107  0.830  1.476  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1182  0.0348  11.5174  .0007  1.125  1.051  1.205  Educational level (Higher education graduate / High school graduate and lower)  1  0.2232  0.0786  8.0565  .0045  1.563  1.148  2.127  Planned to quit smoking (Radical / Not radical)  1  0.1168  0.0889  1.7237  .1892  1.263  0.891  1.790  Quit date within 4 weeks (Yes/No)  1  0.1794  0.1054  2.8974  .0887  1.432  0.947  2.164  Per-protocol adjusted analysis at 3 months (N = 1042)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.9386  0.2171  79.7151  <.0001        Cessation rate at 3 months  1  0.2725  0.0708  14.8051  .0001  1.724  1.306  2.276  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1896  0.0344  30.3160  <.0001  1.209  1.130  1.293  Educational level (Higher education graduate / High school graduate and lower)  1  0.2185  0.0757  8.3345  .0039  1.548  1.151  2.083  Duration of longest quit attempta (>1 month / ≤1 month)  1  0.2232  0.0735  9.2214  .0024  1.563  1.172  2.085  Planned to quit smoking (Radical / Not radical)  1  0.2490  0.0847  8.6352  .0033  1.646  1.180  2.294  Quit date within 4 weeks (yes/no)  1  0.4060  0.1047  15.0284  .0001  2.252  1.494  3.396  Per-protocol adjusted analysis at 6 months (N = 1082)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −0.7287  0.0847  74.0246  <.0001      Cessation rate at 6 months  1  0.1176  0.0604  3.7928  .0515  1.265  0.998  1.603  Confounders  Educational level (Higher education graduate / High school graduate and lower)  1  0.2220  0.0645  11.8435  .0006  1.559  1.211  2.008  Planned to quit smoking (Radical / Not radical)  1  0.2317  0.0715  10.5191  .0012  1.590  1.201  2.103  Quit date within 4 weeks (Yes/No)  1  0.3858  0.0857  20.2460  <.0001  2.163  1.546  3.028  Per-protocol adjusted analysis at 12 months (N = 953)    Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.3556  0.2127  40.6059  <.0001      Cessation rate at 12 months  1  0.0508  0.0734  0.4786  .4891  1.107  0.830  1.476  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1182  0.0348  11.5174  .0007  1.125  1.051  1.205  Educational level (Higher education graduate / High school graduate and lower)  1  0.2232  0.0786  8.0565  .0045  1.563  1.148  2.127  Planned to quit smoking (Radical / Not radical)  1  0.1168  0.0889  1.7237  .1892  1.263  0.891  1.790  Quit date within 4 weeks (Yes/No)  1  0.1794  0.1054  2.8974  .0887  1.432  0.947  2.164  df = degree of freedom; SE = standard error; aOR = adjusted odds ratio; 95% CI = 95% confidence intervals. aDuration = 0 if no previous attempt. View Large Table 4. 7-Day Point Prevalence Smoking Abstinence at 3, 6, and 12 Months—Per-Protocol Adjusted Analysis Per-protocol adjusted analysis at 3 months (N = 1042)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.9386  0.2171  79.7151  <.0001        Cessation rate at 3 months  1  0.2725  0.0708  14.8051  .0001  1.724  1.306  2.276  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1896  0.0344  30.3160  <.0001  1.209  1.130  1.293  Educational level (Higher education graduate / High school graduate and lower)  1  0.2185  0.0757  8.3345  .0039  1.548  1.151  2.083  Duration of longest quit attempta (>1 month / ≤1 month)  1  0.2232  0.0735  9.2214  .0024  1.563  1.172  2.085  Planned to quit smoking (Radical / Not radical)  1  0.2490  0.0847  8.6352  .0033  1.646  1.180  2.294  Quit date within 4 weeks (yes/no)  1  0.4060  0.1047  15.0284  .0001  2.252  1.494  3.396  Per-protocol adjusted analysis at 6 months (N = 1082)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −0.7287  0.0847  74.0246  <.0001      Cessation rate at 6 months  1  0.1176  0.0604  3.7928  .0515  1.265  0.998  1.603  Confounders  Educational level (Higher education graduate / High school graduate and lower)  1  0.2220  0.0645  11.8435  .0006  1.559  1.211  2.008  Planned to quit smoking (Radical / Not radical)  1  0.2317  0.0715  10.5191  .0012  1.590  1.201  2.103  Quit date within 4 weeks (Yes/No)  1  0.3858  0.0857  20.2460  <.0001  2.163  1.546  3.028  Per-protocol adjusted analysis at 12 months (N = 953)    Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.3556  0.2127  40.6059  <.0001      Cessation rate at 12 months  1  0.0508  0.0734  0.4786  .4891  1.107  0.830  1.476  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1182  0.0348  11.5174  .0007  1.125  1.051  1.205  Educational level (Higher education graduate / High school graduate and lower)  1  0.2232  0.0786  8.0565  .0045  1.563  1.148  2.127  Planned to quit smoking (Radical / Not radical)  1  0.1168  0.0889  1.7237  .1892  1.263  0.891  1.790  Quit date within 4 weeks (Yes/No)  1  0.1794  0.1054  2.8974  .0887  1.432  0.947  2.164  Per-protocol adjusted analysis at 3 months (N = 1042)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.9386  0.2171  79.7151  <.0001        Cessation rate at 3 months  1  0.2725  0.0708  14.8051  .0001  1.724  1.306  2.276  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1896  0.0344  30.3160  <.0001  1.209  1.130  1.293  Educational level (Higher education graduate / High school graduate and lower)  1  0.2185  0.0757  8.3345  .0039  1.548  1.151  2.083  Duration of longest quit attempta (>1 month / ≤1 month)  1  0.2232  0.0735  9.2214  .0024  1.563  1.172  2.085  Planned to quit smoking (Radical / Not radical)  1  0.2490  0.0847  8.6352  .0033  1.646  1.180  2.294  Quit date within 4 weeks (yes/no)  1  0.4060  0.1047  15.0284  .0001  2.252  1.494  3.396  Per-protocol adjusted analysis at 6 months (N = 1082)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −0.7287  0.0847  74.0246  <.0001      Cessation rate at 6 months  1  0.1176  0.0604  3.7928  .0515  1.265  0.998  1.603  Confounders  Educational level (Higher education graduate / High school graduate and lower)  1  0.2220  0.0645  11.8435  .0006  1.559  1.211  2.008  Planned to quit smoking (Radical / Not radical)  1  0.2317  0.0715  10.5191  .0012  1.590  1.201  2.103  Quit date within 4 weeks (Yes/No)  1  0.3858  0.0857  20.2460  <.0001  2.163  1.546  3.028  Per-protocol adjusted analysis at 12 months (N = 953)    Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.3556  0.2127  40.6059  <.0001      Cessation rate at 12 months  1  0.0508  0.0734  0.4786  .4891  1.107  0.830  1.476  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1182  0.0348  11.5174  .0007  1.125  1.051  1.205  Educational level (Higher education graduate / High school graduate and lower)  1  0.2232  0.0786  8.0565  .0045  1.563  1.148  2.127  Planned to quit smoking (Radical / Not radical)  1  0.1168  0.0889  1.7237  .1892  1.263  0.891  1.790  Quit date within 4 weeks (Yes/No)  1  0.1794  0.1054  2.8974  .0887  1.432  0.947  2.164  df = degree of freedom; SE = standard error; aOR = adjusted odds ratio; 95% CI = 95% confidence intervals. aDuration = 0 if no previous attempt. View Large Table 5. Repeated Measures Analyses for 7-Day Point Prevalence Smoking Cessation at 3, 6, and 12 Months Generalized linear mixed models for binary data results  Population  N  Time effect  Group effect  Time × group interaction  df  Value  p  df  Value  p  df  Value  p  ITT  2478  2  33.28  <.0001  1  0.05  .8151  2  6.12  .0022  PP no adjustment  1257  2  1.99  .1370  1  15.75  <.0001  2  5.80  .0031  PP with adjustmenta  1170  2  2.45  .0864  1  8.86  .0030  2  5.36  .0048  Generalized linear mixed models for binary data results  Population  N  Time effect  Group effect  Time × group interaction  df  Value  p  df  Value  p  df  Value  p  ITT  2478  2  33.28  <.0001  1  0.05  .8151  2  6.12  .0022  PP no adjustment  1257  2  1.99  .1370  1  15.75  <.0001  2  5.80  .0031  PP with adjustmenta  1170  2  2.45  .0864  1  8.86  .0030  2  5.36  .0048  df = degree of freedom; ITT = intention-to-treat population; PP = per protocol population. aAdjustment for: Level of self-confidence to quit (0 to 10 scale), Educational level (Higher education graduate / High school graduate and lower), Planned to quit smoking (Radical / Not radical), Quit date within 4 weeks (Yes/No) and Duration of longest quit attempt (>1 month / ≤1 month). All these effects were significant in the model. View Large Table 5. Repeated Measures Analyses for 7-Day Point Prevalence Smoking Cessation at 3, 6, and 12 Months Generalized linear mixed models for binary data results  Population  N  Time effect  Group effect  Time × group interaction  df  Value  p  df  Value  p  df  Value  p  ITT  2478  2  33.28  <.0001  1  0.05  .8151  2  6.12  .0022  PP no adjustment  1257  2  1.99  .1370  1  15.75  <.0001  2  5.80  .0031  PP with adjustmenta  1170  2  2.45  .0864  1  8.86  .0030  2  5.36  .0048  Generalized linear mixed models for binary data results  Population  N  Time effect  Group effect  Time × group interaction  df  Value  p  df  Value  p  df  Value  p  ITT  2478  2  33.28  <.0001  1  0.05  .8151  2  6.12  .0022  PP no adjustment  1257  2  1.99  .1370  1  15.75  <.0001  2  5.80  .0031  PP with adjustmenta  1170  2  2.45  .0864  1  8.86  .0030  2  5.36  .0048  df = degree of freedom; ITT = intention-to-treat population; PP = per protocol population. aAdjustment for: Level of self-confidence to quit (0 to 10 scale), Educational level (Higher education graduate / High school graduate and lower), Planned to quit smoking (Radical / Not radical), Quit date within 4 weeks (Yes/No) and Duration of longest quit attempt (>1 month / ≤1 month). All these effects were significant in the model. View Large Discussion We investigated the effect of a web-based personalized, 3-month smoking cessation program among French smokers. The program significantly increased self-reported 7-day abstinence rate in the short term (at 3 months). At 6 and 12 months, the effect of the online counseling on smoking cessation rate was no longer significant in the ITT population. The fact that no effect was detected at 6 months is consistent with the results of other studies: the Cochrane review collected trials that compared an interactive or tailored Internet intervention, or both, with Internet intervention non-tailored, noninteractive, and did not detect any evidence of a difference at 6 months.13,14 The effect of e-coaching was essentially observed at the end of the 3-month period during which it was administered, and no longer observed after 3 months. Accordingly, one avenue to consider might be to extend the online support as has been reported for some other web-based cessation tools such as the Happy ending program in Norway.6 Another potential explanation for the lack of any significant effect of e-coaching on long-term, post-intervention abstinence rate, might be linked to the design of our study: having active control groups leads to more mixed results than wait-list control groups.22–24 In other words, the intervention which is supposed to be a control may have an active effect itself, minimizing the odds of detecting a difference of cessation rate between the groups.15 The overall abstinence rates were higher than in previous studies.6,10,12 This could be due to the inclusion of highly motivated smokers, that is, smokers who made the effort to search for stop smoking aids on a specialized website. This is in line with the observation that highly motivated smokers are more likely to give up smoking than smokers with low motivation.25 Thus, our results cannot be generalizable to smokers less motivated, to those who declined to sign up, and to those who do not use the Internet. In the PP population, compared to the control intervention, the program significantly increased self-reported 7-day abstinence rate at 3 months and remained significant at 6 months, meaning that participants who follow and adhered to the program had a higher likelihood of being abstinent even 3 months after the end of the intervention (p = .05). The secondary analyses in the PP population show that there is a link between intervention and abstinence among smokers who actually follow the program, and that the intervention can lead to changes that persist after the intervention. The fact that program effectiveness seemed to be associated with the extent to which the program was used by smokers is consistent with previous reports. For example, Moskowitz et al. assessed a basic Internet cognitive-behavioral program versus an enhanced Internet program, and found that the effectiveness of the latter was significantly higher among program completers than among non-completers (28 % vs. 5 %, p < .001, N = 403).26 Moreover, the present study did not include complementary self-help tools which are known to increase abstinence efficacy when combined. One example is telephone counseling with enhanced Internet help.27,28 Another is Internet help cessation programs with support from a social network.29,30 New studies investigating the efficacy of programs combining different support tools, and which specifically target subgroups in the general population, must be encouraged. Another important area of research is to examine the best ways to encourage smokers (especially those with socioeconomic problems) to use Internet support in order to quit. This is a complicated area as there are strong social, generational and cultural factors associated with using the Internet for smoking cessation,31 such as educational level and age.25 One positive finding is that a 2014 experimental study32 showed that an Internet-based program could be effective in smokers with low socioeconomic status. Strengths and Limitations Due to the complexity of cultural differences, for instance, the transferability of intervention from one country to another is hard to anticipate. As a result, a new evaluation is needed when adapting a program in another country: the coaching intervention (content, rhythm, duration), its acceptability by smokers, adhesion to Internet may be different. This study is the first to evaluate the e-coaching program in France. Moreover, one can hypothesize that, smoking prevalence, and the cultural and regulatory context may also influence adhesion to the program and its efficacy, as well. Regarding limitations, first of all, tobacco abstinence was self-reported and not biochemically validated and could thus be biased. Yet, the Society for Research on Nicotine and Tobacco Subcommittee on biochemical verification in clinical trials considers that biochemical validation is unnecessary when trials include a large population and when face-to-face contact is limited,33 which is the case in this study. Second, this study was conducted in 2010 and the technological evolution has been rapid since: easier email-access on the go, changing patterns in the use of smartphones. The efficacy evaluation should be repeated to produce results that take into account the current context. However the present experiment is very useful to justify the continuation and the development of this intervention for reducing the tobacco consumption, and the deployment of the intervention on smartphone, launched in 2016. Third, the survey was Internet-based with no phone or face-to-face contact. Internet surveys used to be perceived as less reliable, however, according to Graham & Papandonatos, data collection by the Internet is as reliable as by phone, even for hard-to-reach populations.34 Fourth, the follow-up rate was relatively low compared to other studies: between 50% and 59% in our study, compared with 70% to 90% in other studies.6,9,10 The high attrition rate may show the lack of engagement of e-coaching group participants. Moreover, the attrition rate was higher among young, males, unemployed, students, the least qualified smokers and also according to some characteristics of tobacco consumption (high dependence, low desire to quit). These characteristics of smokers lost to follow-up are typically found in studies concerning smoking cessation.9 Conclusion Analyzed intention-to-treat, our tailored and personalized Internet-based cessation program was superior to a smoking cessation booklet at 3 months, end of intervention, but no more superior at 6 and 12 months follow-up. Among those who actually followed the program (PP population), the effectiveness of e-coaching is observed in the short-term (at 3 months) but also in the medium-term, 3 months after the intervention is stopped. A more holistic approach to helping to stop should be favored, to strengthen the adhesion and to be more efficient. Declaration of Interests The STAMP study was designed by researchers working for Santé publique France—the French National Public Health Agency—which developed and currently manages the smoking cessation support tools provided in the study (the web-based e-coaching program and PDF booklet). Acknowledgments The authors thank Olivier Delmer, Julie-Mattéa Fourès, Olivier Smadja, Raphaël Andler, Caroline Lutz, Christine Riccucci, Bérengère Gall, BVA. References 1. Portnoy DB, Scott-Sheldon LA, Johnson BT, Carey MP. Computer-delivered interventions for health promotion and behavioral risk reduction: a meta-analysis of 75 randomized controlled trials, 1988-2007. Prev Med . 2008; 47( 1): 3– 16. Google Scholar CrossRef Search ADS PubMed  2. Revere D, Dunbar PJ. Review of computer-generated outpatient health behavior interventions: clinical encounters “in absentia”. J Am Med Inform Assoc . 2001; 8( 1): 62– 79. Google Scholar CrossRef Search ADS PubMed  3. Wantland DJ, Portillo CJ, Holzemer WL, Slaughter R, McGhee EM. The effectiveness of Web-based vs. non-Web-based interventions: a meta-analysis of behavioral change outcomes. J Med Internet Res . 2004; 6( 4): e40. Google Scholar CrossRef Search ADS PubMed  4. Webb TL, Joseph J, Yardley L, Michie S. Using the internet to promote health behavior change: a systematic review and meta-analysis of the impact of theoretical basis, use of behavior change techniques, and mode of delivery on efficacy. J Med Internet Res . 2010; 12( 1): e4. Google Scholar CrossRef Search ADS PubMed  5. Brendryen H, Drozd F, Kraft P. A digital smoking cessation program delivered through internet and cell phone without nicotine replacement (happy ending): randomized controlled trial. J Med Internet Res . 2008; 10( 5): e51. Google Scholar CrossRef Search ADS PubMed  6. Brendryen H, Kraft P. Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention. Addiction . 2008; 103( 3): 478– 84; discussion 485. Google Scholar CrossRef Search ADS PubMed  7. Civljak M, Stead LF, Hartmann-Boyce J, Sheikh A, Car J. Internet-based interventions for smoking cessation. Cochrane Database Syst Rev . 2013; 7: CD007078. 8. Elfeddali I, Bolman C, Candel MJ, Wiers RW, de Vries H. Preventing smoking relapse via Web-based computer-tailored feedback: a randomized controlled trial. J Med Internet Res . 2012; 14( 4): e109. Google Scholar CrossRef Search ADS PubMed  9. Graham AL, Cobb NK, Papandonatos GDet al.   A randomized trial of Internet and telephone treatment for smoking cessation. Arch Intern Med . 2011; 171( 1): 46– 53. Google Scholar CrossRef Search ADS PubMed  10. Haug S, Meyer C, John U. Efficacy of an internet program for smoking cessation during and after inpatient rehabilitation treatment: a quasi-randomized controlled trial. Addict Behav . 2011; 36( 12): 1369– 1372. Google Scholar CrossRef Search ADS PubMed  11. Smit ES, de Vries H, Hoving C. Effectiveness of a Web-based multiple tailored smoking cessation program: a randomized controlled trial among Dutch adult smokers. J Med Internet Res . 2012; 14( 3): e82. Google Scholar CrossRef Search ADS PubMed  12. Swartz LH, Noell JW, Schroeder SW, Ary DV. A randomised control study of a fully automated internet based smoking cessation programme. Tob Control . 2006; 15( 1): 7– 12. Google Scholar CrossRef Search ADS PubMed  13. Graham AL, Carpenter KM, Cha Set al.   Systematic review and meta-analysis of Internet interventions for smoking cessation among adults. Subst Abuse Rehabil . 2016; 7: 55– 69. Google Scholar CrossRef Search ADS PubMed  14. Taylor GMJ, Dalili MN, Semwal M, Civljak M, Sheikh A, Car J. Internet-based interventions for smoking cessation. Cochrane Database Syst Rev . 2017; 9: CD007078. Google Scholar PubMed  15. Lancaster T, Stead LF. Self-help interventions for smoking cessation. Cochrane Database Syst Rev . 2005; 3( 3). 16. Institut national de prévention et d’éducation pour la santé. Questionnaires de l’étude STAMP. 2010. http://inpes.santepubliquefrance.fr/evaluation/etudes-experimentales.asp. Accessed November 13, 2017. 17. Heatherton TF, Kozlowski LT, Frecker RC, Rickert W, Robinson J. Measuring the heaviness of smoking: using self-reported time to the first cigarette of the day and number of cigarettes smoked per day. Br J Addict . 1989; 84( 7): 791– 799. Google Scholar CrossRef Search ADS PubMed  18. Miller WR, Rollnick S. Motivational Interviewing: Preparing People for Change . New York: Guilford Press; 2002. 19. Prochaska JO, DiClemente CC. Stages of change in the modification of problem behaviors. Prog Behav Modif . 1992; 28: 183– 218. Google Scholar PubMed  20. Institut national de prévention et d’éducation pour la santé. J’arrête de fumer. Saint-Denis, France: INPES; 2009 :32. 21. Casagrande JT, Pike MC, Smith PG. An improved approximate formula for calculating sample sizes for comparing two binomial distributions. Biometrics . 1978; 34( 3): 483– 486. Google Scholar CrossRef Search ADS PubMed  22. Humfleet GL, Hall SM, Delucchi KL, Dilley JW. A randomized clinical trial of smoking cessation treatments provided in HIV clinical care settings. Nicotine Tob Res . 2013; 15( 8): 1436– 1445. Google Scholar CrossRef Search ADS PubMed  23. Patten CA, Croghan IT, Meis TMet al.   Randomized clinical trial of an Internet-based versus brief office intervention for adolescent smoking cessation. Patient Educ Couns . 2006; 64( 1–3): 249– 258. Google Scholar CrossRef Search ADS PubMed  24. Swan GE, McClure JB, Jack LMet al.   Behavioral counseling and varenicline treatment for smoking cessation. Am J Prev Med . 2010; 38( 5): 482– 490. Google Scholar CrossRef Search ADS PubMed  25. Skov-Ettrup LS, Dalum P, Ekholm O, Tolstrup JS. Reach and uptake of Internet- and phone-based smoking cessation interventions: results from a randomized controlled trial. Prev Med . 2014; 62: 38– 43. Google Scholar CrossRef Search ADS PubMed  26. Moskowitz JM, McDonnell DD, Kazinets G, Lee HJ. Online smoking cessation program for Korean Americans: randomized trial to test effects of incentives for program completion and interim surveys. Prev Med . 2016; 86: 70– 76. Google Scholar CrossRef Search ADS PubMed  27. Cobb CO, Graham AL. Use of non-assigned interventions in a randomized trial of internet and telephone treatment for smoking cessation. Nicotine Tob Res . 2014; 16( 10): 1289– 1297. Google Scholar CrossRef Search ADS PubMed  28. Graham AL, Papandonatos GD, Cobb COet al.   Internet and Telephone Treatment for smoking cessation: mediators and moderators of short-term abstinence. Nicotine Tob Res . 2015; 17( 3): 299– 308. Google Scholar CrossRef Search ADS PubMed  29. Graham AL, Papandonatos GD, Erar B, Stanton CA. Use of an online smoking cessation community promotes abstinence: results of propensity score weighting. Health Psychol . 2015; 34S: 1286– 1295. Google Scholar CrossRef Search ADS PubMed  30. Ramo DE, Thrul J, Chavez K, Delucchi KL, Prochaska JJ. Feasibility and quit rates of the tobacco status project: a Facebook smoking cessation intervention for young adults. J Med Internet Res . 2015; 17( 12): e291. Google Scholar CrossRef Search ADS PubMed  31. Borland R, Li L, Driezen Pet al.   Cessation assistance reported by smokers in 15 countries participating in the International Tobacco Control (ITC) policy evaluation surveys. Addiction . 2012; 107( 1): 197– 205. Google Scholar CrossRef Search ADS PubMed  32. Brown J, Michie S, Geraghty AWet al.   Internet-based intervention for smoking cessation (StopAdvisor) in people with low and high socioeconomic status: a randomised controlled trial. Lancet Respir Med . 2014; 2( 12): 997– 1006. Google Scholar CrossRef Search ADS PubMed  33. Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res . 2003; 5( 1): 13– 25. Google Scholar CrossRef Search ADS PubMed  34. Graham AL, Papandonatos GD. Reliability of internet- versus telephone-administered questionnaires in a diverse sample of smokers. J Med Internet Res . 2008; 10( 1): e8. Google Scholar CrossRef Search ADS PubMed  © The Author(s) 2018. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Nicotine and Tobacco Research Oxford University Press

Effectiveness of a Fully Automated Internet-Based Smoking Cessation Program: A Randomized Controlled Trial (STAMP)

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Oxford University Press
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© The Author(s) 2018. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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1462-2203
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D.O.I.
10.1093/ntr/nty016
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Abstract

Abstract Introduction The Internet offers an interesting alternative to face-to-face and telephone-based support for smoking cessation. This study was designed to assess the effectiveness of a personalized and automated Internet-based program. Methods French current adult smokers willing to quit within 2 weeks were recruited for a randomized controlled trial. The intervention consisted of an automated program of 45 e-mails (“e-coaching”) sent over a 3-month period. The control group received a PDF version of a booklet on smoking cessation. Self-reported 7-day point prevalence smoking abstinence was measured at 6 months (primary outcome), at 3 and 12 months of follow-up (secondary outcomes). Results 2478 smokers were randomized (1242 for e-coaching, 1236 for the booklet). Cessation rate in the intention-to-treat population was not significantly different between the two groups at 6 and 12 months, but was higher in the e-coaching group at 3 months than in the control group (27.5% vs. 23.5%, p = .02, odds ratio [OR] = 1.24, confidence interval [CI] = [1.03–1.49]). After adjustment for baseline conditions, the effect of the intervention in the per-protocol (PP) sample was significant at 3 months (adjusted odds ratio [aOR] = 1.72 [1.31–2.28], p < .001, N = 1042) and at 6 months (aOR = 1.27 [1.00–1.60], p = .05, N = 1082). GLM repeated measure analyses showed significant group by time interaction in the intent-to-treat and a significant group effect in the PP population. Conclusions Analyzed intention-to-treat, e-coaching was superior to a booklet at 3 months (end of intervention) but no more superior at 6 and 12 months follow-up. Among those who actually followed the program, the effectiveness is also observed 3 months after the intervention is stopped. Implications Analyzed intention-to-treat, our French tailored and personalized Internet-based cessation program was superior to a smoking cessation booklet at 3 months (end of intervention) but no more superior at 6 months follow-up. Among those who actually followed the program (PP population), the effectiveness is observed in the short-term but also 3 months after the intervention is stopped. Introduction Given the huge burden of diseases attributed to tobacco use, it is crucial to develop effective smoking cessation interventions to help smokers quit. Smoking cessation aids like pharmacotherapy, telephone, and face-to-face counseling, are expensive and resource-demanding. The Internet offers an interesting alternative to the latter strategies. In particular, automated programs are resource-saving, as their costs are effectively limited to program development, and accessing them is not limited by opening hours.1–4 Research has focused on the effectiveness of these types of interventions for more than a decade.2–12 In a recent review of 40 randomized trials published between 1990 and 2015 (98530 participants included), the authors concluded that the efficacy of Internet interventions is superior to print materials and equivalent to face-to-face counseling and telephone interventions.13 Web-based programs may help achieve long-term smoking cessation under specific conditions, particularly when they are intensive, interactive and tailored to individuals.14 It is crucial to describe precisely the intervention in order to identify the active components associated with its effectiveness. Taking into account findings from the literature, a personalized and fully automated Internet-based cessation program (hereafter referred to as e-coaching) was developed for French-speaking smokers in 2009. The STAMP (Sevrage Tabagique Assisté par Mailing Personnalisé) study was designed to assess the effectiveness of this program, and its results are reported in this article. Methods Hypothesis Our hypothesis was that the e-coaching would lead to higher abstinence rates than a self-help booklet at 6 months of follow-up (primary outcome), at 3 months (end of the intervention) and 12 months of follow-up (secondary outcomes).7–12,14,15 Trial Design The STAMP study was a two-arm randomized controlled trial that compared a fully automated, web-based smoking cessation program with a downloadable 30-page self-help booklet. Participants The enrollment period extended from March to November 2010. Participants were recruited directly from among the visitors of the national website (“tabac-info-service.fr”). No specific announcement or advertising was created for the study recruitment, to avoid the risk of attracting smokers whose profile differed from that of usual visitors of the website. Smokers who clicked on the banner which read “Get some help to quit smoking” were directed to the recruitment website created specifically for this study. The study protocol was approved by the institutional review board (IRB) of the Pitié Salpétrière Hospital (Comité de protection des personnes Ile de France 6) in January 2010. In accordance with the International committee of medical journal editors (ICMJE) requirements, the STAMP study was registered prospectively before recruitment of the participants. ClinicalTrials.gov identifier: NCT01073085. Recruitment The study website described the objectives and the stages of the study. It explained that a 12-month trial was being conducted to compare several types of smoking cessation help (no specific information was given on the types of help), and that if the visitor participated, he/she would be provided with one type of help and asked to answer four questionnaires sent by e-mail over the 12-month period. Those who completed the four questionnaires would receive a 10 € voucher, and five winners would be randomly drawn to receive a 500 € voucher. There was no restriction on the use of other smoking cessation strategies during the STAMP study. The eligibility criteria were: being 18 years or older, being a current cigarette smoker (manufactured or roll-your-own tobacco cigarettes), having a personal e-mail address, willing to quit within 2 weeks, and not having previously benefited from e-coaching. Eligible participants were asked to provide their informed consent to participate directly on the website. Those who received the baseline questionnaire were checked again to meet eligibility criteria. Baseline Questionnaire At baseline, all participants were asked to fill in a questionnaire16 about demographic characteristics (age, sex, educational level), Body Mass Index (BMI), alcohol consumption and smoking behaviors and attitudes: time before first cigarette in the morning, how long they had been smokers, number of previous quit attempts, duration of longest quit attempt, self-efficacy, motivation to quit, and whether they (1) planned to quit smoking cold turkey or gradually cutting down the number of cigarettes, (2) planned to use medications to quit, (3) planned to quit in the next 1 month or within 6 months. Three educational levels were considered: lower than high school, high school graduate, and higher education graduate. Alcohol consumption data were collected for the previous 7 days and respondents were recoded into the following categories: abstinent, not an at-risk alcohol user (less than 21 and 14 alcohol units per week for men and women, respectively), an at-risk alcohol user (more than 21 and 14 alcohol units per week for men and women, respectively). The level of tobacco dependence was assessed by the Heaviness of Smoking Index. Heaviness of Smoking Index was computed by taking the sum of two categorized measures: the number of cigarettes per day and time before smoking the first cigarette of the day. Heaviness of Smoking Index values ranged from 0 to 6 with higher values indicating stronger tobacco addiction: 0–1 weak tobacco dependence, 2–3 moderate tobacco dependence and 4–6 high tobacco dependence.17 Self-efficacy and motivation of the participants to quit were assessed by asking them to rate their level of self-confidence and motivation on a 0 to 10 scale.18 Participants were also asked to set a quit date, recommended to be within 2 weeks to allow for a period of preparation. Intervention E-coaching The intervention consisted of a fully automated program of about 45 e-mails over a period of about 3 and half months. Once a quit date had been chosen by the smoker, e-mails to prepare them for smoking cessation were sent during the 15 days before the date (seven e-mails). From the quit date, e-mails were sent over a 3-month period, initially with a high frequency which then decreased: one e-mail per day for the first week after quitting tobacco (seven e-mails), one e-mail every 2 days for 6 weeks (21 e-mails), then one e-mail every 4 days for the remaining 6 weeks (10 e-mails). No more e-mails were sent after these 3 months after the quit date. Developed by the French Institute for Health Promotion and Health Education (now Santé publique France, the national public health agency), this automated program (automatic sending of e-mails)—entitled e-coaching—was hosted by the governmental website dedicated to smoking cessation (www.tabac-info-service.fr), and was completely free of charge to users. The design of the program and the content of the e-mails were developed by smoking cessation treatment specialists. E-coaching is largely based on techniques inspired by motivational interviewing and cognitive behavioral therapy. The e-mails sent before the quit date provided information about the harms of smoking, advice on how to anticipate difficulties and develop coping strategies to face them, as well as exercises to enhance motivation. On the quit date, a series of e-mails were sent with congratulations, information about the health benefits already occurring, advice on how to maintain abstinence and how to manage relapses. The content is mainly text, with links to specific brochures, for example for nutrition advice. Registrants were divided into 14 profiles according to age, sex, level of tobacco dependence, motivation to quit, past quit attempts and a profile for pregnant women, according to the data collected at baseline (Table 1). The number and frequency of e-mails were mostly identical for all profiles. The content of the e-mails of all profiles was based on the stages of the theory of change.19 Specific contents was added according to user profiles, for example, a specific online pamphlet “Pregnancy and Tobacco” and specific advice were sent to pregnant women, content on tobacco-related representations was sent to young people to act on the image of cigarettes, more specific nutrition advice was sent to women aged 19–35 to avoid weight gain, more advice for managing nicotine withdrawal and the use of nicotine replacement therapies were directed to heavily dependent smokers. Table 1. Fourteen Profiles of E-coaching Young    Profile 1  Young 18 years old or younger, with weak or moderate tobacco dependencea  Profile 2  Young 18 years old or younger, with high tobacco dependencea  Pregnant woman  Profile 3  Pregnant woman or planning pregnancy  19–50 ans (except profiles 10 and 11)  Profile 4  19–50 years with high tobacco dependence, little or moderately motivated, first attempt to quit smoking  Profile 5  19–50 years with high tobacco dependence, little or moderately motivated, new attempt to quit smoking  Profile 6  19–50 years with high tobacco dependence, very motivated, new attempt to quit smoking  Profile 7  19–50 years with high tobacco dependence, very motivated, first attempt to quit smoking  Profile 8  19–50 years with moderate tobacco dependence, little or moderately motivated  Profile 9  19–50 years with moderate tobacco dependence, very motivated  Woman 19–35 years  Profile 10  Female 19–35 years with weak tobacco dependence, little or moderately motivated  Profile 11  Female 19–35 years with moderate tobacco dependence, little motivated  Over 50 years  Profile 12  Man or woman over 50, with weak or moderate tobacco dependence, little or moderately motivated, first quit attempt  Profile 13  Man or woman over 50 with high tobacco dependence, moderately or very motivated, new attempt to quit smoking  Others  Profile 14  All smokers who do not match other profiles  Young    Profile 1  Young 18 years old or younger, with weak or moderate tobacco dependencea  Profile 2  Young 18 years old or younger, with high tobacco dependencea  Pregnant woman  Profile 3  Pregnant woman or planning pregnancy  19–50 ans (except profiles 10 and 11)  Profile 4  19–50 years with high tobacco dependence, little or moderately motivated, first attempt to quit smoking  Profile 5  19–50 years with high tobacco dependence, little or moderately motivated, new attempt to quit smoking  Profile 6  19–50 years with high tobacco dependence, very motivated, new attempt to quit smoking  Profile 7  19–50 years with high tobacco dependence, very motivated, first attempt to quit smoking  Profile 8  19–50 years with moderate tobacco dependence, little or moderately motivated  Profile 9  19–50 years with moderate tobacco dependence, very motivated  Woman 19–35 years  Profile 10  Female 19–35 years with weak tobacco dependence, little or moderately motivated  Profile 11  Female 19–35 years with moderate tobacco dependence, little motivated  Over 50 years  Profile 12  Man or woman over 50, with weak or moderate tobacco dependence, little or moderately motivated, first quit attempt  Profile 13  Man or woman over 50 with high tobacco dependence, moderately or very motivated, new attempt to quit smoking  Others  Profile 14  All smokers who do not match other profiles  HSI = Heaviness of Smoking Index. aHigh tobacco dependence: HSI 4 to 6; Moderate tobacco dependence: HSI 2 or 3; Weak tobacco dependence: HSI 0 or 1. View Large Table 1. Fourteen Profiles of E-coaching Young    Profile 1  Young 18 years old or younger, with weak or moderate tobacco dependencea  Profile 2  Young 18 years old or younger, with high tobacco dependencea  Pregnant woman  Profile 3  Pregnant woman or planning pregnancy  19–50 ans (except profiles 10 and 11)  Profile 4  19–50 years with high tobacco dependence, little or moderately motivated, first attempt to quit smoking  Profile 5  19–50 years with high tobacco dependence, little or moderately motivated, new attempt to quit smoking  Profile 6  19–50 years with high tobacco dependence, very motivated, new attempt to quit smoking  Profile 7  19–50 years with high tobacco dependence, very motivated, first attempt to quit smoking  Profile 8  19–50 years with moderate tobacco dependence, little or moderately motivated  Profile 9  19–50 years with moderate tobacco dependence, very motivated  Woman 19–35 years  Profile 10  Female 19–35 years with weak tobacco dependence, little or moderately motivated  Profile 11  Female 19–35 years with moderate tobacco dependence, little motivated  Over 50 years  Profile 12  Man or woman over 50, with weak or moderate tobacco dependence, little or moderately motivated, first quit attempt  Profile 13  Man or woman over 50 with high tobacco dependence, moderately or very motivated, new attempt to quit smoking  Others  Profile 14  All smokers who do not match other profiles  Young    Profile 1  Young 18 years old or younger, with weak or moderate tobacco dependencea  Profile 2  Young 18 years old or younger, with high tobacco dependencea  Pregnant woman  Profile 3  Pregnant woman or planning pregnancy  19–50 ans (except profiles 10 and 11)  Profile 4  19–50 years with high tobacco dependence, little or moderately motivated, first attempt to quit smoking  Profile 5  19–50 years with high tobacco dependence, little or moderately motivated, new attempt to quit smoking  Profile 6  19–50 years with high tobacco dependence, very motivated, new attempt to quit smoking  Profile 7  19–50 years with high tobacco dependence, very motivated, first attempt to quit smoking  Profile 8  19–50 years with moderate tobacco dependence, little or moderately motivated  Profile 9  19–50 years with moderate tobacco dependence, very motivated  Woman 19–35 years  Profile 10  Female 19–35 years with weak tobacco dependence, little or moderately motivated  Profile 11  Female 19–35 years with moderate tobacco dependence, little motivated  Over 50 years  Profile 12  Man or woman over 50, with weak or moderate tobacco dependence, little or moderately motivated, first quit attempt  Profile 13  Man or woman over 50 with high tobacco dependence, moderately or very motivated, new attempt to quit smoking  Others  Profile 14  All smokers who do not match other profiles  HSI = Heaviness of Smoking Index. aHigh tobacco dependence: HSI 4 to 6; Moderate tobacco dependence: HSI 2 or 3; Weak tobacco dependence: HSI 0 or 1. View Large Control Participants in the control group received a PDF version of a 30-page booklet entitled “J’arrête de fumer” (“I quit smoking”). Like e-coaching, this self-help tool was developed by the French Institute for Health Promotion and Health Education and is available free of charge online.20 The booklet is structured on the stages of change theory,19 like e-coaching, with four chapters: “I smoke,” “I hesitate over quitting,” “I have decided to quit,” and “I quit”. Each chapter contains information, exercises and advice related to the current stage of change in the smoker’s behavior. Randomization Based on computer-generated random digits, eligible participants who fully completed the baseline questionnaire were randomly allocated to either receive the automated intervention (e-coaching group) or the booklet (booklet group) with a 1:1 allocation ratio. After randomization, each participant received an e-mail with either a link to the e-coaching registration page or to a PDF version of the smoking cessation booklet. Sample Size The sample size calculation was based on an estimated 5% abstinence rate in the control group at 6 months15 and a hypothesized increase of four points in the e-coaching group compared to the control group, with an alpha = 0.05 for type I error and 1-beta = 0.20 (type II error), using Casagrande and Pike formula.21 Assuming an attrition rate of 40%, 1150 participants per group were required. Outcomes Web-based questionnaires were sent 3, 6, and 12 months after inclusion in the study.16 An e-mail was sent with a link to the questionnaire, and two subsequent e-mail reminders were sent 4 and 10 days later to nonrespondents. The primary outcome was self-reported 7-day point prevalence smoking abstinence at 6 months of follow-up. Secondary outcomes were 7-day point prevalence smoking abstinence at 3 and 12 months of follow-up. Use of the allocated assistance (e-coaching or booklet) was also evaluated with the question “To what extent did you read/use the e-mails (e-coaching group) / the booklet (booklet group) you received.” Data Management and Statistical Methods Data Management To measure abstinence, the participants at the 3, 6, and 12-month follow-ups were asked if they were current smokers. Those who responded “no” were then asked how long they had been abstinent. This method of measuring abstinence allowed to assess the general consistency of the data set: for example, a participant who declared he/she had been abstinent for 4 months on the 6-month questionnaire would have also declared being abstinent for 1 month on the 3-month questionnaire. More importantly, this method allowed to partly compensate for the attrition at 3 and 6 months of follow-up by using later surveys: for example, if a participant did not respond to our 3-month survey but reported that he/she had been abstinent for (at least) 97 days at 6 months of follow-up, it was consequently deduced that he/she was 7-day point prevalence smoking abstinent at 3 months. At the end of data collection, the data set was checked and completed following these same principles. Statistical Methods To compare the two groups (e-coaching vs. control) on sociodemographic characteristics and baseline measurements, Pearson’s chi-square test and Student’s t test were used for categorical and continuous variables, respectively. The primary analysis was the conservative intent-to-treat (ITT) method, where data from all randomized participants were analyzed and non-respondents or missing values considered as smokers. The secondary analyses were per-protocol (PP) analyses: only participants for whom at least one abstinence datum was available and who had followed the proposed protocol were included: in the e-coaching group participants had to have read the e-mails “systematically” or “often,” and in the booklet group they had to have read the booklet “entirely” or “partially”. Thus, analyses were not limited to respondents’ data in either the ITT or PP analyses, as some abstinence data could be recovered from later survey waves for non-respondents (see “data management” section). To evaluate the effects of the intervention on abstinence, cessation rates were compared between the e-coaching and the booklet group, at each time point separately (3, 6 and 12 months) using Pearson’s chi-square test for unpaired data. Crude odds ratios (ORs) were also estimated for each comparison. Then logistic regressions on data from the PP population were used to estimate the effects among people who actually followed the intervention, by controlling for potential confounders at baseline. Confounders were chosen by a two-steps method: first, sociodemographic and baseline characteristics variables were selected from the global PP (test between the two groups e-coaching vs. control with p value < .1). Then, these selected variables were tested again between the two groups on the PP populations at each time (subjects from the PP available at 3, 6, or 12 months). Logistic regression models were conducted to explain the abstinence at each time, incorporating the group (variable of interest) as well as the previously selected confounders. Adjusted odds-ratios (aORs) and their 95% confidence intervals (95% CIs) were estimated from these final models. Finally, repeated measures analyses were performed using a Generalized Linear Mixed Models for binary data (SAS Glimmix Procedure) with the group and the time as fixed effects, the subject as random effect. The interaction between the group and the time was also tested. This analysis was performed without adjustment in the ITT population. It was performed without and with adjustment on previously determined confounders in the PP population. Results Recruitment During the 9-month recruitment period, 330000 people visited the website; 45335 clicked on the “Get some help to quit smoking” banner; 15412 began completing the screening questionnaire; 4724 were eligible, and 2478 gave their informed consent and were finally randomized (1242 in the e-coaching group and 1236 in the booklet group). Randomization was stopped when the predetermined sample size was reached. Following the CONSORT recommendations, we depicted the flow of participants for each step of the study (Figure 1). Participation rates at each follow-up ranged between 52.3% and 58.7%. Figure 1. View largeDownload slide Flow of study participants. By definition, the intention-to-treat (ITT) population is the same at each time-point. The number of participants with smoking status at 3 and 6 months takes into account the data collected in subsequent waves (see “Data management” section). Figure 1. View largeDownload slide Flow of study participants. By definition, the intention-to-treat (ITT) population is the same at each time-point. The number of participants with smoking status at 3 and 6 months takes into account the data collected in subsequent waves (see “Data management” section). Baseline Data Table 2 presents the sociodemographic and smoking-related characteristics at baseline for the two groups. 1607 of the 2478 participants (64.8%) were female. The age of the respondents ranged from 18 to 77 years, and the mean age was 36 (SD 9.8) years. Four hundred ninety-five persons (20.0%) had an educational level lower than high school diploma, 410 (16.5%) had a high school diploma, and 1573 (63.5%) had a higher level of education. Table 2. Sociodemographic and Smoking-Related Characteristics at Baseline for the Two Groups   Total randomized (N = 2478)  Intervention group (N = 1242): e-coaching  Control group (N = 1236): booklet    n  %  n  %  n  %  p value for difference  Sex   Male  871  35.2  426  34.3  445  36.0  .374   Female  1607  64.8  816  65.7  791  64.0    Age (years)   18–24  286  11.5  126  10.1  160  12.9  .086   25–39  1429  57.7  725  58.4  704  57.0     40–54  662  26.7  333  26.8  329  26.6     ≥55  101  4.1  58  4.7  43  3.5    Mean age (SD)  35.9 (9.8)    36.2 (9.8)    35.6 (9.7)    .133  Education   Lower than high school  495  20.0  246  19.8  249  20.2  .205   High school completed  410  16.5  190  15.3  220  17.8     Higher education graduate  1573  63.5  806  64.9  767  62.1    Tobacco dependence (HSI)   0–1 (low)  684  27.6  358  28.9  326  26.4  .317   2–3 (moderate)  1139  46.0  568  45.8  571  46.2     4–6 (high)  653  26.4  315  25.4  338  27.4    Previous quit attempts (yes)    1976  79.7  996  80.2  980  79.3  .575  Self-efficacy in quitting   0–1 (low)  121  4.9  56  4.5  65  5.3  .283   2–5  1114  45.0  557  44.9  557  45.1     6–8  1006  40.6  521  42.0  485  39.2     9–10 (high)  237  9.6  108  8.7  129  10.4    Motivation to quit   0–5 (low)  138  5.6  58  4.7  80  6.5  .132   6–8  916  37.0  469  37.8  447  36.2     9–10 (high)  1424  57.5  715  57.6  709  57.4      Total randomized (N = 2478)  Intervention group (N = 1242): e-coaching  Control group (N = 1236): booklet    n  %  n  %  n  %  p value for difference  Sex   Male  871  35.2  426  34.3  445  36.0  .374   Female  1607  64.8  816  65.7  791  64.0    Age (years)   18–24  286  11.5  126  10.1  160  12.9  .086   25–39  1429  57.7  725  58.4  704  57.0     40–54  662  26.7  333  26.8  329  26.6     ≥55  101  4.1  58  4.7  43  3.5    Mean age (SD)  35.9 (9.8)    36.2 (9.8)    35.6 (9.7)    .133  Education   Lower than high school  495  20.0  246  19.8  249  20.2  .205   High school completed  410  16.5  190  15.3  220  17.8     Higher education graduate  1573  63.5  806  64.9  767  62.1    Tobacco dependence (HSI)   0–1 (low)  684  27.6  358  28.9  326  26.4  .317   2–3 (moderate)  1139  46.0  568  45.8  571  46.2     4–6 (high)  653  26.4  315  25.4  338  27.4    Previous quit attempts (yes)    1976  79.7  996  80.2  980  79.3  .575  Self-efficacy in quitting   0–1 (low)  121  4.9  56  4.5  65  5.3  .283   2–5  1114  45.0  557  44.9  557  45.1     6–8  1006  40.6  521  42.0  485  39.2     9–10 (high)  237  9.6  108  8.7  129  10.4    Motivation to quit   0–5 (low)  138  5.6  58  4.7  80  6.5  .132   6–8  916  37.0  469  37.8  447  36.2     9–10 (high)  1424  57.5  715  57.6  709  57.4    HSI = Heaviness of Smoking Index. View Large Table 2. Sociodemographic and Smoking-Related Characteristics at Baseline for the Two Groups   Total randomized (N = 2478)  Intervention group (N = 1242): e-coaching  Control group (N = 1236): booklet    n  %  n  %  n  %  p value for difference  Sex   Male  871  35.2  426  34.3  445  36.0  .374   Female  1607  64.8  816  65.7  791  64.0    Age (years)   18–24  286  11.5  126  10.1  160  12.9  .086   25–39  1429  57.7  725  58.4  704  57.0     40–54  662  26.7  333  26.8  329  26.6     ≥55  101  4.1  58  4.7  43  3.5    Mean age (SD)  35.9 (9.8)    36.2 (9.8)    35.6 (9.7)    .133  Education   Lower than high school  495  20.0  246  19.8  249  20.2  .205   High school completed  410  16.5  190  15.3  220  17.8     Higher education graduate  1573  63.5  806  64.9  767  62.1    Tobacco dependence (HSI)   0–1 (low)  684  27.6  358  28.9  326  26.4  .317   2–3 (moderate)  1139  46.0  568  45.8  571  46.2     4–6 (high)  653  26.4  315  25.4  338  27.4    Previous quit attempts (yes)    1976  79.7  996  80.2  980  79.3  .575  Self-efficacy in quitting   0–1 (low)  121  4.9  56  4.5  65  5.3  .283   2–5  1114  45.0  557  44.9  557  45.1     6–8  1006  40.6  521  42.0  485  39.2     9–10 (high)  237  9.6  108  8.7  129  10.4    Motivation to quit   0–5 (low)  138  5.6  58  4.7  80  6.5  .132   6–8  916  37.0  469  37.8  447  36.2     9–10 (high)  1424  57.5  715  57.6  709  57.4      Total randomized (N = 2478)  Intervention group (N = 1242): e-coaching  Control group (N = 1236): booklet    n  %  n  %  n  %  p value for difference  Sex   Male  871  35.2  426  34.3  445  36.0  .374   Female  1607  64.8  816  65.7  791  64.0    Age (years)   18–24  286  11.5  126  10.1  160  12.9  .086   25–39  1429  57.7  725  58.4  704  57.0     40–54  662  26.7  333  26.8  329  26.6     ≥55  101  4.1  58  4.7  43  3.5    Mean age (SD)  35.9 (9.8)    36.2 (9.8)    35.6 (9.7)    .133  Education   Lower than high school  495  20.0  246  19.8  249  20.2  .205   High school completed  410  16.5  190  15.3  220  17.8     Higher education graduate  1573  63.5  806  64.9  767  62.1    Tobacco dependence (HSI)   0–1 (low)  684  27.6  358  28.9  326  26.4  .317   2–3 (moderate)  1139  46.0  568  45.8  571  46.2     4–6 (high)  653  26.4  315  25.4  338  27.4    Previous quit attempts (yes)    1976  79.7  996  80.2  980  79.3  .575  Self-efficacy in quitting   0–1 (low)  121  4.9  56  4.5  65  5.3  .283   2–5  1114  45.0  557  44.9  557  45.1     6–8  1006  40.6  521  42.0  485  39.2     9–10 (high)  237  9.6  108  8.7  129  10.4    Motivation to quit   0–5 (low)  138  5.6  58  4.7  80  6.5  .132   6–8  916  37.0  469  37.8  447  36.2     9–10 (high)  1424  57.5  715  57.6  709  57.4    HSI = Heaviness of Smoking Index. View Large 2401 participants (96.9%) were daily smokers. On average, participants smoked 16 (SD 7.8) cigarettes per day, 653 (26.4%) were strongly dependent on tobacco (Heaviness of Smoking Index between 4 and 6) and 1976 (79.7%) had made previous quit attempts (7-day attempts or longer). 1243 participants (50.2%) rated their self-efficacy as greater than or equal to 6 (out of 10), and 2340 participants (94.4%) rated their motivation to quit as greater than or equal to 6 (out of 10). No significant difference was found (p > .05) between the two groups for the baseline measurements of socio-demographic data, smoking-related items, self-efficacy and motivation. Attrition Check The data management procedure enabled to recover data for 273 abstinence episodes at 3 months of follow-up (11.0% of the whole sample) and for 63 episodes at 6 months of follow-up (2.5% of the whole sample). It also helped us to spot six and two episodes of inconsistent data at 3 and 6 months of follow-up, respectively. These data were not corrected, in order to favor collected data over extrapolated data. Attrition Rate Analysis The participants without any follow-up (30.5%) were compared with those with at least one follow-up assessment. Attrition rate was higher among certain socio-demographic groups (p < .05): males (33.8% were lost-to-follow-up vs. 28.7% in females), smokers aged 18–25 (37.2% vs. 29.3% in smokers aged more than 25), students and unemployed smokers (respectively 36.0% and 37.9% vs. 28.5% in employed and 29.5% in retired smokers), smokers with a level of education lower than or equal to secondary (36.4% vs. 27.1% in college graduate). Attrition was also higher according to some characteristics of tobacco consumption (p < .05): a high dependence (35.1% vs. 30.3% for moderate dependence and 26.5% for low dependence), no quit attempt of at least a week in the past (36.9% vs. 28.8%), not planning to quit in the next month (36.3% vs. 28.6%) and not planning to use medication (33.7% vs. 27.5%). Outcomes and Estimation Cessation rates in the ITT population were significantly different between the two groups at 3 months (end of the intervention), but not at 6 and 12 months follow-ups (Table 3, Figure 2). The cessation rates at 3, 6, and 12 months were, respectively, 27.5% (e-coaching group, N = 342/1242) versus 23.5% (booklet group, N = 290/1236), 24.7% (N = 307/1242) versus 24.7% (N = 305/1236) and 20.9% (N = 259/1242) versus 20.6% (N = 254/1236). Repeated measures analysis showed a significant Group × Time interaction (p = .002) and a significant time effect (p < .001) (Table 5). Table 3. 7-Day Point Prevalence Smoking Abstinence at 3, 6, and 12 Months—Unadjusted Analysis Intent-to-treat analyses    E-coaching group N = 1242  Booklet group N = 1236  χ2  OR  df  Value  p  Value  95% CI  Cessation rate at 3 months  27.5% (N = 342)  23.5% (N = 290)  1  5.41  .02  1.24  [1.03–1.49]  Cessation rate at 6 months  24.7% (N = 307)  24.7% (N = 305)  1  0.001  .98  1.00  [0.83–1.20]  Cessation rate at 12 months  20.9% (N = 259)  20.6% (N = 254)  1  0.03  .85  1.02  [0.84–1.24]  Per protocol analyses        χ2  OR  E-coaching group  Booklet group  df  Value  p  Value  95% CI  Cessation rate at 3 months  48.9% (N = 295/603)  34.3% (N = 177/516)  1  24.37  <.001  1.83  [1.44–2.34]  Cessation rate at 6 months  46.1% (N = 265/575)  38.1% (N = 193/507)  1  7.10  .01  1.39  [1.09–1.77]  Cessation rate at 12 months   41.8% (N = 213/510)  37.0% (N = 164/443)  1  2.23  .14  1.22  [0.94–1.58]  Intent-to-treat analyses    E-coaching group N = 1242  Booklet group N = 1236  χ2  OR  df  Value  p  Value  95% CI  Cessation rate at 3 months  27.5% (N = 342)  23.5% (N = 290)  1  5.41  .02  1.24  [1.03–1.49]  Cessation rate at 6 months  24.7% (N = 307)  24.7% (N = 305)  1  0.001  .98  1.00  [0.83–1.20]  Cessation rate at 12 months  20.9% (N = 259)  20.6% (N = 254)  1  0.03  .85  1.02  [0.84–1.24]  Per protocol analyses        χ2  OR  E-coaching group  Booklet group  df  Value  p  Value  95% CI  Cessation rate at 3 months  48.9% (N = 295/603)  34.3% (N = 177/516)  1  24.37  <.001  1.83  [1.44–2.34]  Cessation rate at 6 months  46.1% (N = 265/575)  38.1% (N = 193/507)  1  7.10  .01  1.39  [1.09–1.77]  Cessation rate at 12 months   41.8% (N = 213/510)  37.0% (N = 164/443)  1  2.23  .14  1.22  [0.94–1.58]  df = degree of freedom; OR = unadjusted odds ratio; 95% CI = 95 % confidence intervals. View Large Table 3. 7-Day Point Prevalence Smoking Abstinence at 3, 6, and 12 Months—Unadjusted Analysis Intent-to-treat analyses    E-coaching group N = 1242  Booklet group N = 1236  χ2  OR  df  Value  p  Value  95% CI  Cessation rate at 3 months  27.5% (N = 342)  23.5% (N = 290)  1  5.41  .02  1.24  [1.03–1.49]  Cessation rate at 6 months  24.7% (N = 307)  24.7% (N = 305)  1  0.001  .98  1.00  [0.83–1.20]  Cessation rate at 12 months  20.9% (N = 259)  20.6% (N = 254)  1  0.03  .85  1.02  [0.84–1.24]  Per protocol analyses        χ2  OR  E-coaching group  Booklet group  df  Value  p  Value  95% CI  Cessation rate at 3 months  48.9% (N = 295/603)  34.3% (N = 177/516)  1  24.37  <.001  1.83  [1.44–2.34]  Cessation rate at 6 months  46.1% (N = 265/575)  38.1% (N = 193/507)  1  7.10  .01  1.39  [1.09–1.77]  Cessation rate at 12 months   41.8% (N = 213/510)  37.0% (N = 164/443)  1  2.23  .14  1.22  [0.94–1.58]  Intent-to-treat analyses    E-coaching group N = 1242  Booklet group N = 1236  χ2  OR  df  Value  p  Value  95% CI  Cessation rate at 3 months  27.5% (N = 342)  23.5% (N = 290)  1  5.41  .02  1.24  [1.03–1.49]  Cessation rate at 6 months  24.7% (N = 307)  24.7% (N = 305)  1  0.001  .98  1.00  [0.83–1.20]  Cessation rate at 12 months  20.9% (N = 259)  20.6% (N = 254)  1  0.03  .85  1.02  [0.84–1.24]  Per protocol analyses        χ2  OR  E-coaching group  Booklet group  df  Value  p  Value  95% CI  Cessation rate at 3 months  48.9% (N = 295/603)  34.3% (N = 177/516)  1  24.37  <.001  1.83  [1.44–2.34]  Cessation rate at 6 months  46.1% (N = 265/575)  38.1% (N = 193/507)  1  7.10  .01  1.39  [1.09–1.77]  Cessation rate at 12 months   41.8% (N = 213/510)  37.0% (N = 164/443)  1  2.23  .14  1.22  [0.94–1.58]  df = degree of freedom; OR = unadjusted odds ratio; 95% CI = 95 % confidence intervals. View Large Figure 2. View largeDownload slide Cessation rates at 3, 6, and 12 months. ITT: intention-to-treat population; PP: per protocol population. *p < .05, **p < .01, ***p < .001. Figure 2. View largeDownload slide Cessation rates at 3, 6, and 12 months. ITT: intention-to-treat population; PP: per protocol population. *p < .05, **p < .01, ***p < .001. Cessation rates in the PP population were significantly different between the two groups at 3 months and at 6, but not at 12 months (Table 3, Figure 2): cessation rates at 3, 6 and 12 months were, respectively, 48.9% (e-coaching group, N = 295/603) versus 34.3% (booklet group, N = 177/516), 46.1% (N = 265/575) versus 38.1% (N = 193/507) and 41.8% (N = 213/510) versus 37.0% (N = 164/443). After adjustment for baseline variables in the PP population (Table 4), the effect of e-coaching was significant at 3 months (aOR = 1.72 [1.31–2.28], p < .001, N = 1042) and at 6 months (aOR = 1.27 [1.00–1.60], p = .05, N = 1082). At 12 months, there was no significant difference: the adjusted odds-ratio was 1.11 [0.83–1.48] (p = .49, N = 953). Thus, the pattern of results from the logistic regression matches the pattern of results from the unadjusted analysis. Repeated measures analyses showed a significant group effect both without (p < .001) and with adjustment (p = .003), suggesting an overall higher cessation rate in the e-coaching than in the control group (Table 5). Table 4. 7-Day Point Prevalence Smoking Abstinence at 3, 6, and 12 Months—Per-Protocol Adjusted Analysis Per-protocol adjusted analysis at 3 months (N = 1042)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.9386  0.2171  79.7151  <.0001        Cessation rate at 3 months  1  0.2725  0.0708  14.8051  .0001  1.724  1.306  2.276  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1896  0.0344  30.3160  <.0001  1.209  1.130  1.293  Educational level (Higher education graduate / High school graduate and lower)  1  0.2185  0.0757  8.3345  .0039  1.548  1.151  2.083  Duration of longest quit attempta (>1 month / ≤1 month)  1  0.2232  0.0735  9.2214  .0024  1.563  1.172  2.085  Planned to quit smoking (Radical / Not radical)  1  0.2490  0.0847  8.6352  .0033  1.646  1.180  2.294  Quit date within 4 weeks (yes/no)  1  0.4060  0.1047  15.0284  .0001  2.252  1.494  3.396  Per-protocol adjusted analysis at 6 months (N = 1082)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −0.7287  0.0847  74.0246  <.0001      Cessation rate at 6 months  1  0.1176  0.0604  3.7928  .0515  1.265  0.998  1.603  Confounders  Educational level (Higher education graduate / High school graduate and lower)  1  0.2220  0.0645  11.8435  .0006  1.559  1.211  2.008  Planned to quit smoking (Radical / Not radical)  1  0.2317  0.0715  10.5191  .0012  1.590  1.201  2.103  Quit date within 4 weeks (Yes/No)  1  0.3858  0.0857  20.2460  <.0001  2.163  1.546  3.028  Per-protocol adjusted analysis at 12 months (N = 953)    Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.3556  0.2127  40.6059  <.0001      Cessation rate at 12 months  1  0.0508  0.0734  0.4786  .4891  1.107  0.830  1.476  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1182  0.0348  11.5174  .0007  1.125  1.051  1.205  Educational level (Higher education graduate / High school graduate and lower)  1  0.2232  0.0786  8.0565  .0045  1.563  1.148  2.127  Planned to quit smoking (Radical / Not radical)  1  0.1168  0.0889  1.7237  .1892  1.263  0.891  1.790  Quit date within 4 weeks (Yes/No)  1  0.1794  0.1054  2.8974  .0887  1.432  0.947  2.164  Per-protocol adjusted analysis at 3 months (N = 1042)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.9386  0.2171  79.7151  <.0001        Cessation rate at 3 months  1  0.2725  0.0708  14.8051  .0001  1.724  1.306  2.276  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1896  0.0344  30.3160  <.0001  1.209  1.130  1.293  Educational level (Higher education graduate / High school graduate and lower)  1  0.2185  0.0757  8.3345  .0039  1.548  1.151  2.083  Duration of longest quit attempta (>1 month / ≤1 month)  1  0.2232  0.0735  9.2214  .0024  1.563  1.172  2.085  Planned to quit smoking (Radical / Not radical)  1  0.2490  0.0847  8.6352  .0033  1.646  1.180  2.294  Quit date within 4 weeks (yes/no)  1  0.4060  0.1047  15.0284  .0001  2.252  1.494  3.396  Per-protocol adjusted analysis at 6 months (N = 1082)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −0.7287  0.0847  74.0246  <.0001      Cessation rate at 6 months  1  0.1176  0.0604  3.7928  .0515  1.265  0.998  1.603  Confounders  Educational level (Higher education graduate / High school graduate and lower)  1  0.2220  0.0645  11.8435  .0006  1.559  1.211  2.008  Planned to quit smoking (Radical / Not radical)  1  0.2317  0.0715  10.5191  .0012  1.590  1.201  2.103  Quit date within 4 weeks (Yes/No)  1  0.3858  0.0857  20.2460  <.0001  2.163  1.546  3.028  Per-protocol adjusted analysis at 12 months (N = 953)    Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.3556  0.2127  40.6059  <.0001      Cessation rate at 12 months  1  0.0508  0.0734  0.4786  .4891  1.107  0.830  1.476  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1182  0.0348  11.5174  .0007  1.125  1.051  1.205  Educational level (Higher education graduate / High school graduate and lower)  1  0.2232  0.0786  8.0565  .0045  1.563  1.148  2.127  Planned to quit smoking (Radical / Not radical)  1  0.1168  0.0889  1.7237  .1892  1.263  0.891  1.790  Quit date within 4 weeks (Yes/No)  1  0.1794  0.1054  2.8974  .0887  1.432  0.947  2.164  df = degree of freedom; SE = standard error; aOR = adjusted odds ratio; 95% CI = 95% confidence intervals. aDuration = 0 if no previous attempt. View Large Table 4. 7-Day Point Prevalence Smoking Abstinence at 3, 6, and 12 Months—Per-Protocol Adjusted Analysis Per-protocol adjusted analysis at 3 months (N = 1042)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.9386  0.2171  79.7151  <.0001        Cessation rate at 3 months  1  0.2725  0.0708  14.8051  .0001  1.724  1.306  2.276  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1896  0.0344  30.3160  <.0001  1.209  1.130  1.293  Educational level (Higher education graduate / High school graduate and lower)  1  0.2185  0.0757  8.3345  .0039  1.548  1.151  2.083  Duration of longest quit attempta (>1 month / ≤1 month)  1  0.2232  0.0735  9.2214  .0024  1.563  1.172  2.085  Planned to quit smoking (Radical / Not radical)  1  0.2490  0.0847  8.6352  .0033  1.646  1.180  2.294  Quit date within 4 weeks (yes/no)  1  0.4060  0.1047  15.0284  .0001  2.252  1.494  3.396  Per-protocol adjusted analysis at 6 months (N = 1082)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −0.7287  0.0847  74.0246  <.0001      Cessation rate at 6 months  1  0.1176  0.0604  3.7928  .0515  1.265  0.998  1.603  Confounders  Educational level (Higher education graduate / High school graduate and lower)  1  0.2220  0.0645  11.8435  .0006  1.559  1.211  2.008  Planned to quit smoking (Radical / Not radical)  1  0.2317  0.0715  10.5191  .0012  1.590  1.201  2.103  Quit date within 4 weeks (Yes/No)  1  0.3858  0.0857  20.2460  <.0001  2.163  1.546  3.028  Per-protocol adjusted analysis at 12 months (N = 953)    Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.3556  0.2127  40.6059  <.0001      Cessation rate at 12 months  1  0.0508  0.0734  0.4786  .4891  1.107  0.830  1.476  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1182  0.0348  11.5174  .0007  1.125  1.051  1.205  Educational level (Higher education graduate / High school graduate and lower)  1  0.2232  0.0786  8.0565  .0045  1.563  1.148  2.127  Planned to quit smoking (Radical / Not radical)  1  0.1168  0.0889  1.7237  .1892  1.263  0.891  1.790  Quit date within 4 weeks (Yes/No)  1  0.1794  0.1054  2.8974  .0887  1.432  0.947  2.164  Per-protocol adjusted analysis at 3 months (N = 1042)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.9386  0.2171  79.7151  <.0001        Cessation rate at 3 months  1  0.2725  0.0708  14.8051  .0001  1.724  1.306  2.276  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1896  0.0344  30.3160  <.0001  1.209  1.130  1.293  Educational level (Higher education graduate / High school graduate and lower)  1  0.2185  0.0757  8.3345  .0039  1.548  1.151  2.083  Duration of longest quit attempta (>1 month / ≤1 month)  1  0.2232  0.0735  9.2214  .0024  1.563  1.172  2.085  Planned to quit smoking (Radical / Not radical)  1  0.2490  0.0847  8.6352  .0033  1.646  1.180  2.294  Quit date within 4 weeks (yes/no)  1  0.4060  0.1047  15.0284  .0001  2.252  1.494  3.396  Per-protocol adjusted analysis at 6 months (N = 1082)          Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −0.7287  0.0847  74.0246  <.0001      Cessation rate at 6 months  1  0.1176  0.0604  3.7928  .0515  1.265  0.998  1.603  Confounders  Educational level (Higher education graduate / High school graduate and lower)  1  0.2220  0.0645  11.8435  .0006  1.559  1.211  2.008  Planned to quit smoking (Radical / Not radical)  1  0.2317  0.0715  10.5191  .0012  1.590  1.201  2.103  Quit date within 4 weeks (Yes/No)  1  0.3858  0.0857  20.2460  <.0001  2.163  1.546  3.028  Per-protocol adjusted analysis at 12 months (N = 953)    Wald χ2  Variable  df  β  SE (β)  Value  p  aOR  95% CI  Intercept  1  −1.3556  0.2127  40.6059  <.0001      Cessation rate at 12 months  1  0.0508  0.0734  0.4786  .4891  1.107  0.830  1.476  Confounders  Level of self-confidence to quit (0 to 10 scale)  1  0.1182  0.0348  11.5174  .0007  1.125  1.051  1.205  Educational level (Higher education graduate / High school graduate and lower)  1  0.2232  0.0786  8.0565  .0045  1.563  1.148  2.127  Planned to quit smoking (Radical / Not radical)  1  0.1168  0.0889  1.7237  .1892  1.263  0.891  1.790  Quit date within 4 weeks (Yes/No)  1  0.1794  0.1054  2.8974  .0887  1.432  0.947  2.164  df = degree of freedom; SE = standard error; aOR = adjusted odds ratio; 95% CI = 95% confidence intervals. aDuration = 0 if no previous attempt. View Large Table 5. Repeated Measures Analyses for 7-Day Point Prevalence Smoking Cessation at 3, 6, and 12 Months Generalized linear mixed models for binary data results  Population  N  Time effect  Group effect  Time × group interaction  df  Value  p  df  Value  p  df  Value  p  ITT  2478  2  33.28  <.0001  1  0.05  .8151  2  6.12  .0022  PP no adjustment  1257  2  1.99  .1370  1  15.75  <.0001  2  5.80  .0031  PP with adjustmenta  1170  2  2.45  .0864  1  8.86  .0030  2  5.36  .0048  Generalized linear mixed models for binary data results  Population  N  Time effect  Group effect  Time × group interaction  df  Value  p  df  Value  p  df  Value  p  ITT  2478  2  33.28  <.0001  1  0.05  .8151  2  6.12  .0022  PP no adjustment  1257  2  1.99  .1370  1  15.75  <.0001  2  5.80  .0031  PP with adjustmenta  1170  2  2.45  .0864  1  8.86  .0030  2  5.36  .0048  df = degree of freedom; ITT = intention-to-treat population; PP = per protocol population. aAdjustment for: Level of self-confidence to quit (0 to 10 scale), Educational level (Higher education graduate / High school graduate and lower), Planned to quit smoking (Radical / Not radical), Quit date within 4 weeks (Yes/No) and Duration of longest quit attempt (>1 month / ≤1 month). All these effects were significant in the model. View Large Table 5. Repeated Measures Analyses for 7-Day Point Prevalence Smoking Cessation at 3, 6, and 12 Months Generalized linear mixed models for binary data results  Population  N  Time effect  Group effect  Time × group interaction  df  Value  p  df  Value  p  df  Value  p  ITT  2478  2  33.28  <.0001  1  0.05  .8151  2  6.12  .0022  PP no adjustment  1257  2  1.99  .1370  1  15.75  <.0001  2  5.80  .0031  PP with adjustmenta  1170  2  2.45  .0864  1  8.86  .0030  2  5.36  .0048  Generalized linear mixed models for binary data results  Population  N  Time effect  Group effect  Time × group interaction  df  Value  p  df  Value  p  df  Value  p  ITT  2478  2  33.28  <.0001  1  0.05  .8151  2  6.12  .0022  PP no adjustment  1257  2  1.99  .1370  1  15.75  <.0001  2  5.80  .0031  PP with adjustmenta  1170  2  2.45  .0864  1  8.86  .0030  2  5.36  .0048  df = degree of freedom; ITT = intention-to-treat population; PP = per protocol population. aAdjustment for: Level of self-confidence to quit (0 to 10 scale), Educational level (Higher education graduate / High school graduate and lower), Planned to quit smoking (Radical / Not radical), Quit date within 4 weeks (Yes/No) and Duration of longest quit attempt (>1 month / ≤1 month). All these effects were significant in the model. View Large Discussion We investigated the effect of a web-based personalized, 3-month smoking cessation program among French smokers. The program significantly increased self-reported 7-day abstinence rate in the short term (at 3 months). At 6 and 12 months, the effect of the online counseling on smoking cessation rate was no longer significant in the ITT population. The fact that no effect was detected at 6 months is consistent with the results of other studies: the Cochrane review collected trials that compared an interactive or tailored Internet intervention, or both, with Internet intervention non-tailored, noninteractive, and did not detect any evidence of a difference at 6 months.13,14 The effect of e-coaching was essentially observed at the end of the 3-month period during which it was administered, and no longer observed after 3 months. Accordingly, one avenue to consider might be to extend the online support as has been reported for some other web-based cessation tools such as the Happy ending program in Norway.6 Another potential explanation for the lack of any significant effect of e-coaching on long-term, post-intervention abstinence rate, might be linked to the design of our study: having active control groups leads to more mixed results than wait-list control groups.22–24 In other words, the intervention which is supposed to be a control may have an active effect itself, minimizing the odds of detecting a difference of cessation rate between the groups.15 The overall abstinence rates were higher than in previous studies.6,10,12 This could be due to the inclusion of highly motivated smokers, that is, smokers who made the effort to search for stop smoking aids on a specialized website. This is in line with the observation that highly motivated smokers are more likely to give up smoking than smokers with low motivation.25 Thus, our results cannot be generalizable to smokers less motivated, to those who declined to sign up, and to those who do not use the Internet. In the PP population, compared to the control intervention, the program significantly increased self-reported 7-day abstinence rate at 3 months and remained significant at 6 months, meaning that participants who follow and adhered to the program had a higher likelihood of being abstinent even 3 months after the end of the intervention (p = .05). The secondary analyses in the PP population show that there is a link between intervention and abstinence among smokers who actually follow the program, and that the intervention can lead to changes that persist after the intervention. The fact that program effectiveness seemed to be associated with the extent to which the program was used by smokers is consistent with previous reports. For example, Moskowitz et al. assessed a basic Internet cognitive-behavioral program versus an enhanced Internet program, and found that the effectiveness of the latter was significantly higher among program completers than among non-completers (28 % vs. 5 %, p < .001, N = 403).26 Moreover, the present study did not include complementary self-help tools which are known to increase abstinence efficacy when combined. One example is telephone counseling with enhanced Internet help.27,28 Another is Internet help cessation programs with support from a social network.29,30 New studies investigating the efficacy of programs combining different support tools, and which specifically target subgroups in the general population, must be encouraged. Another important area of research is to examine the best ways to encourage smokers (especially those with socioeconomic problems) to use Internet support in order to quit. This is a complicated area as there are strong social, generational and cultural factors associated with using the Internet for smoking cessation,31 such as educational level and age.25 One positive finding is that a 2014 experimental study32 showed that an Internet-based program could be effective in smokers with low socioeconomic status. Strengths and Limitations Due to the complexity of cultural differences, for instance, the transferability of intervention from one country to another is hard to anticipate. As a result, a new evaluation is needed when adapting a program in another country: the coaching intervention (content, rhythm, duration), its acceptability by smokers, adhesion to Internet may be different. This study is the first to evaluate the e-coaching program in France. Moreover, one can hypothesize that, smoking prevalence, and the cultural and regulatory context may also influence adhesion to the program and its efficacy, as well. Regarding limitations, first of all, tobacco abstinence was self-reported and not biochemically validated and could thus be biased. Yet, the Society for Research on Nicotine and Tobacco Subcommittee on biochemical verification in clinical trials considers that biochemical validation is unnecessary when trials include a large population and when face-to-face contact is limited,33 which is the case in this study. Second, this study was conducted in 2010 and the technological evolution has been rapid since: easier email-access on the go, changing patterns in the use of smartphones. The efficacy evaluation should be repeated to produce results that take into account the current context. However the present experiment is very useful to justify the continuation and the development of this intervention for reducing the tobacco consumption, and the deployment of the intervention on smartphone, launched in 2016. Third, the survey was Internet-based with no phone or face-to-face contact. Internet surveys used to be perceived as less reliable, however, according to Graham & Papandonatos, data collection by the Internet is as reliable as by phone, even for hard-to-reach populations.34 Fourth, the follow-up rate was relatively low compared to other studies: between 50% and 59% in our study, compared with 70% to 90% in other studies.6,9,10 The high attrition rate may show the lack of engagement of e-coaching group participants. Moreover, the attrition rate was higher among young, males, unemployed, students, the least qualified smokers and also according to some characteristics of tobacco consumption (high dependence, low desire to quit). These characteristics of smokers lost to follow-up are typically found in studies concerning smoking cessation.9 Conclusion Analyzed intention-to-treat, our tailored and personalized Internet-based cessation program was superior to a smoking cessation booklet at 3 months, end of intervention, but no more superior at 6 and 12 months follow-up. Among those who actually followed the program (PP population), the effectiveness of e-coaching is observed in the short-term (at 3 months) but also in the medium-term, 3 months after the intervention is stopped. A more holistic approach to helping to stop should be favored, to strengthen the adhesion and to be more efficient. Declaration of Interests The STAMP study was designed by researchers working for Santé publique France—the French National Public Health Agency—which developed and currently manages the smoking cessation support tools provided in the study (the web-based e-coaching program and PDF booklet). Acknowledgments The authors thank Olivier Delmer, Julie-Mattéa Fourès, Olivier Smadja, Raphaël Andler, Caroline Lutz, Christine Riccucci, Bérengère Gall, BVA. References 1. Portnoy DB, Scott-Sheldon LA, Johnson BT, Carey MP. Computer-delivered interventions for health promotion and behavioral risk reduction: a meta-analysis of 75 randomized controlled trials, 1988-2007. Prev Med . 2008; 47( 1): 3– 16. Google Scholar CrossRef Search ADS PubMed  2. Revere D, Dunbar PJ. Review of computer-generated outpatient health behavior interventions: clinical encounters “in absentia”. J Am Med Inform Assoc . 2001; 8( 1): 62– 79. Google Scholar CrossRef Search ADS PubMed  3. Wantland DJ, Portillo CJ, Holzemer WL, Slaughter R, McGhee EM. The effectiveness of Web-based vs. non-Web-based interventions: a meta-analysis of behavioral change outcomes. J Med Internet Res . 2004; 6( 4): e40. Google Scholar CrossRef Search ADS PubMed  4. Webb TL, Joseph J, Yardley L, Michie S. 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Nicotine and Tobacco ResearchOxford University Press

Published: Jan 23, 2018

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