Reducing pediatric caries and obesity risk in South Asian immigrants: randomized controlled trial of common health/risk factor approach

Reducing pediatric caries and obesity risk in South Asian immigrants: randomized controlled trial... Background: This paper describes the design and methods of a multi-phase study to reduce early childhood caries and obesity in vulnerable South Asian (SA) immigrants in the United States. Early childhood caries and obesity are the most common diseases of early childhood. Risk factors for both diseases are rooted in early childhood feeding practices such as bottle feeding and intake of sweets and sweetened beverages. The Common Health/Risk Factor Approach to addressing oral health is widely promoted by the WHO and other policy makers. This approach recognizes links between oral health and other diseases of modernity. Our CHALO! (“Child Health Action to Lower Obesity and Oral health risk”–from a Hindi word meaning "Let's go!") study targets SA families at high risk for early childhood caries and obesity. CHALO! addresses common risk factors associated with these two common diseases of childhood. Methods: This two part project includes a randomized controlled trial, and a Knowledge Translation campaign. A randomized controlled trial will enroll n = 360 families from pediatric practices serving South Asians in the New York metro area. The intervention group will receive home visits by SA community health workers at 6, 8, 10, 12, 14, and 16 months of age. Controls will receive culturally tailored educational material. Primary outcomes– cariogenic and obesogenic feeding practices at 6, 12, and 18 months– will be assessed with the MySmileBuddy iPad based tool. Secondary outcomes include: oral hygiene practices, anthropometrics, and caries incidence at 18 months. A public education campaign will focus on both families and health care providers. Discussion: There are few Common Health/Risk Factor Approach published studies on obesity and oral health risk in children, despite health morbidity and costs associated with both conditions. CHALO! comprises a multi- level interventions designed to promote culturally competent, sustainable change. Trial registration: ClinicalTrials.gov NCT03077425. Keywords: Obesity, Oral health, Caries, Children, Common risk factor approach, South Asian * Correspondence: alison.karasz@einstein.yu.edu Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, New York 10461, USA © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Karasz and Bonuck BMC Public Health (2018) 18:680 Page 2 of 10 Background Bottle use beyond 12–15 months increases risk for both Immigrants from the developing world are impacted by conditions [20–26], as do bottles at night or naptime [22] the global nutrition transition, from low calorie, highly or bottles that contain solids [27] and sweeteners [28]. nutritious foods in resource-poor environments, to the Bottle feeding facilitates overriding of a child’sinternal sa- high calorie, low nutrition diets of the west [1]. Nutrition- tiety cues, [29] thereby reducing ability to self-regulate in- related diseases occur with the adoption of western diets. take [30]. This may further promote both weight gain [31, Obesity and oral caries, the most common diseases of 32] and early childhood caries (ECC) [24]. early childhood in western societies, are prevalent in low Such feeding practices are common in SA communities income immigrant communities [2–4]. The Child Health [33, 34]. Up to 75% of low-income SA 15-month olds still Action to Lower risk of Obesity and Oral caries–CHALO! use a bottle, and 30% regularly drink sweetened milk (“let’sgo!” in Hindi)– is a multi-level intervention cultur- [35–37]. Non-responsive feeding is also common in SA ally tailored for at-risk immigrant South Asians (SAs) from families. Non-responsive feeding’s defining feature is India, Pakistan, and Bangladesh. These SAs are among the caregiver lack of responsiveness to a child’s feeding cues. fastest growing immigrant groups in the US [5, 6]. It includes both adult controlling (forcing or restricting) SAs are particularly vulnerable to nutrition-related and child controlling (indulgent) feeding [38]. Forcing/ disease. A modernizing diet in urban South Asian has controlling feeding leads to rapid weight gain in the first created a public health ‘tsunami’ of obesity and metabolic year of life, which predispose to overweight in later years disorders in that region [7–9]. SA immigrants in the UK [39, 40]. Indulgent styles are associated with obesity in and Canada bear a high burden of obesity-related health toddlers and older children [41]. Among SAs in the New disparities [10–12]. SA immigrant children demonstrate York area, ‘force feeding’ is routine. Once children are old growth patterns associated with metabolic risk: low birth- enough to ask for food, force-feeding yields to indulgent weight followed by steep weight gain in infancy and child- feeding. SA mothers fear distressing their children by re- hood [13]. A tendency towards central adiposity places fusing food [42]. adults and children at high risk for metabolic syndrome In addition to common risk behaviors, there are unique even controlling for body mass index (BMI) [9, 14]. Chil- risk behaviors associated with obesity and caries that are dren are also at high risk for early childhood caries (ECC) common among SA immigrants. SA children are more [15–17], even adjusting for socio-economic status s [18]. sedentary than their white counterparts, raising their risk of obesity [43–46]. Oral health prevention—e.g., brushing, The common risk factor approach oral hygiene, and preventive dental care—are undervalued The Common Risk/Health Factor Approach (CR/HFA) to in SA communities. Many families seek dental care only oral health disparities focuses on risk factors and underlying when there is pain or visible decay; baby teeth may be social determinants shared with other diseases of modernity viewed as dispensable [42, 47, 48]. [19]. Based on the CR/HFA, CHALO! employs a multi- level social-ecological framework for conceptualizing and Interpersonal level influences addressing oral health and obesity risk (See Table 1): SA married women’s low status and limited access to family decision-making may impede adherence to medical advice Individual level influences [42]. Senior family members may insist traditional feeding Maternal feeding practices in early life increase the risk patterns including frequent sweets and delayed weaning of caries (i.e., cariogenic) and obesity (i.e., obesogenic). [37, 42]. Maternal depression—due to factors such as They include: prolonged use of bottles (and ‘sippy cups’); poverty, isolation, and marital abuse—is common in SA adding solids and sweets to bottles; nighttime feeding; families [49–51]. Maternal depression is associated with salty and starchy snacks; sweets, and sweetened beverages. non-responsive feeding [52, 53]and childobesity [41]. Table 1 Outline CHALO Multi Level Intervention Activity Target Level Home Visit with Mothers Knowledge, support, wellbeing, confidence, skills, feeding behaviors Individual Home Visits with Families Family/household support for Mothers’ Goals Interpersonal Dental Referral & Navigation Link families to providers; facilitate appointments Organizational Knowledge Translation –Community Raise awareness & educate via: 1-to-1 outreach, Community local meetings, video/drama Professional Dissemination Educate local providers on AAP & AAPD policy; Community & Policy raise cultural awareness; promote professionals- researcher-policymaker dialogue Karasz and Bonuck BMC Public Health (2018) 18:680 Page 3 of 10 Poverty and its sequelae, including substandard housing, The CHALO project RCT further limit mothers’ ability to change feeding patterns. Methods Such may cause disruption and crying, which may be diffi- To address individual and interpersonal (i.e., household) cult to tolerate in crowded living quarters [42]. risk factors, SA community health workers (CHWs) will conduct a home-visiting intervention. Home Visiting is a Institutional/organizational level influences decades-old strategy to improve maternal-child health Like other low-income immigrants, SA children lack access outcomes [63–65] by empowering families. We will recruit to dental care [4, 54, 55]. Pediatricians rarely refer to den- low-income SA mother-child dyads from pediatric practices tists [4, 54–57]. Guidelines recommend a first dental visit in New York City and New Jersey (U.S.). Inclusion cri- by 12 months of age and two visits per year for low-income teria include: a) Age: Child is < 6 months old at time of re- and immigrant children [58, 59]. Yet only 1.5% of one-year cruitment; b) Insurance: Child is enrolled in either olds visit a dentist each year [60] and rates are lowest in Medicaid or the Children’s Health Insurance Program; poor families who could most benefit [61]. Another barrier c) Nativity: Mother was born in India, Pakistan, or to care for low income children is the fact that many den- Bangladesh); d) Language:Motherspeaksstandard Ben- tists on the US don’t accept Medicaid or Children’sHealth gali, English or Hindi/Urdu; e) Agency:Mother isindex Insurance Program coverage [62]. child’s primary caretaker. Exclusion criteria include: a) In- ability to provide informed consent; b) Plans to travel for > Community level influences 1 month during follow-up, and; c) child health condition These include cultural beliefs and practices, along with barring participation (per pediatrician review). low awareness of risk factors. Though concerns over child feeding are widely shared among SA mothers, there Enhanced usual care (control) is relatively little understanding of how non-responsive An EUC counseling intervention will be delivered imme- feeding leads to child food refusal, creating a vicious cycle diately following the T0 Baseline Interview, just prior to of increased maternal anxiety and force feeding. One SA randomization. EUC Components include: 1) a pamphlet- mother on www.indusladies.com, a website for South Asian containing basic ECC and Obesity prevention messages, moms, asks: "Why do American kids happily feed them- and 2) Dental Referrals. We developed a Screened Dental selves from the age of one year old and are constantly ask- Provider list of dentists who: a) are willing to see 12 month ing for food? Why do Indian kids hate food and need to be old children; and b) accept most insurance plans in the FORCE FED until the age of 4,5,6, or even 7?" Pediatricians study practices. in the SA community often report frustration. “Feeding problems take up 75% of my time.” (Mehotra N, SAPPHIRE Intervention network pediatrician. In.; 2015, personal communication). CHWs will conduct n = 6 home visits when the child is 6, Physicians lack tools and support needed to address this 8, 10, 12, 14, and 16 months old. Of these, 4 visits include problem. “Themostcommonlyprescribedmedicationinmy only the mother-child dyad. Visits at 8 and 14 months will practice is an appetite stimulant. Even though the child include a senior family decision maker (e.g., husband or doesn’t need it, I have to prescribe to get peace in the fam- mother-in-law). CHWs will conduct 6 follow up telephone ily.” (Mehotra N. In.; 2015, personal communication). calls in alternate months. Calls will be used to ask about the family’s goals for change, gauge progress, and assist Policy level influences with trouble shooting. The Knowledge Translation campaign will work with Mother-only visits will focus on building rapport and private practitioners, residents, and teaching faculty in intimacy, identifying family/household concerns, review- dental and pediatric departments. Through dialogue and ing risk/health behaviors, reviewing, setting, and trouble- presentations in clinical and educational settings, the shooting goals, building skills through active interaction goal is to develop new best practices and guidelines re- with the child, and providing education. Messages will garding the improved care of South Asian immigrant be provided orally and via culturally tailored, attractive children. educational materials. To bolster mothers’ skills, CHW- The randomized controlled trial (RCT), CHALO! will guided interactions with the dyads will include: recogniz- answer the following research questions: a) Does a ing infant satiety and hunger cues via responsive bottle culturally-tailored CR/HFA home-visiting intervention, feeding, preparing age-appropriate self-feeding foods, en- from child age 6 through 16 months, reduce cariogenic couraging tummy time and active play, transitioning from and obesogenic behaviors in SA immigrant families (pri- naptime milk to water bottles, and oral hygiene practices mary hypothesis)? b) Is this CR/HFA intervention asso- such as tooth brushing. At each visit, the CHW encour- ciated with reduced incidence of oral caries and obesity ages the mother to set a concrete, manageable behavior at 18 months of age (secondary hypothesis)? change goal. Patient navigation, as needed, will encourage Karasz and Bonuck BMC Public Health (2018) 18:680 Page 4 of 10 mothers to make and keep two dental visits for their child, color photographs of food and beverage groupings. Prior over the 12 month follow-up. Family visits will, similarly, to administration, the research assistant will ask whether assess family views on barriers to change, and enlist sup- the prior 24 h represented a ‘usual day.’ If not, participants port for mothers’ child feeding goals (Fig. 1). will conduct a recall for one day earlier. We will conduct a second 24-h recall for a subset of participants. Outcomes measurement: Unique risk factors for obesity (sedentary behavior/ The RCT’s primary aim is to reduce risk behaviors for screen time) will be assessed through previously vali- caries and obesity. We hypothesize that relative to Controls, dated questionnaire items used in other large studies. the Intervention group will report: less bottle use (any, with Unique ECC-risk factors include dental visits and oral added sweeteners/solids, at nap and bedtimes), improved hygiene practices. We will assess frequency of tooth food choices (more fruits and vegetables, less juice and brushing, use of toothpaste, and use of tap water using sweetened beverages, fewer sweet and salty snacks); items from a measure developed by the CDC. Dental more physical activity and less screen time; and more health utilization will be assessed through questions at tooth brushing and dental visits. See Table 2 for Schedule T1 and T2. of Research Assessments. The RCT’s secondary aim is to reduce the velocity of weight gain in months 12–18, and the incidence of oral Common risk factor feeding behaviors caries at 18 months. Weight and length data will be We will use MySmileBuddy (MSB), an iPad based ECC collected by research assistants at the T0, T1, and T2 risk assessment and educational tool [66]. MSB was val- outcomes assessments. Study pediatricians will train re- idated in previous research [67]. The MSB guides parents search staff in anthropometrics protocol. For length, through a modified 24-h dietary recall for their child. We two supine measures will be taken using infantometers have adapted the MSB to reflect culturally appropriate SA (Seca 417, Brooklyn NY), to the nearest 0.1 cm. For foods and beverages, as well as the types of bottles and weight, children will be measured with diaper and light cups used for beverages. Participants are cued by queries clothing. ECC will be assessed by study staff using (e.g., first thing to eat or drink upon waking) and attractive Intraoral cameras at the 18 month follow-up. Intraoral Fig. 1 Study flow Karasz and Bonuck BMC Public Health (2018) 18:680 Page 5 of 10 Table 2 Schedule of Research Assessments: 6, 12, and 18 Months Recruitment and retention Practices will generate quarterly lists of 2–5 month olds Interview Data Obtained Setting seen for well-child visits. Parents will receive an “opt-out” Baseline @ 6 mos. Questionnaires Home (T0) letter from the pediatrician when their child is 4–5 months MySmileBuddy (MSB) old, with a number to call to decline study contact. Par- Weight/length ents who do not decline will be contacted by study staff to 12 mo. Interview Questionnaires Home arrange a Baseline (T0) interview. We will set individual (T1) MySmileBuddy (MSB) practice target recruitment rates based on target popula- Weight/length tion size at each practice. Strategies to promote retention include: gift card incentives for research interviews, quar- 18 mo. Interview Questionnaires Home (T2) terly post-card reminders and incentives to notify study of MySmileBuddy (MSB) address or name changes, holiday greeting postcards, and Caries Exam reminders for upcoming interviews. Weight/length Randomization and masking cameras are valid [68–72] and acceptable [73]inyoung Participants will be randomized 1:1 to the intervention children. Images will be transmitted to pediatric den- or EUC control group, after providing informed consent tists at the Kodiak who will determine the presence of (see below). Following delivery of the EUC at the T0 (base- visible dental caries and (if any) their severity (Table 3). line) assessment, the CHW will randomize participants by opening a sealed envelope containing the random assign- ment (prepared in advance by the project statistician). This Implementation/Fidelity sequence preserves masking of outcomes assessment at the Home visiting interventions involve three components: T0 interview. Neither the outcomes section of the study Dose (timing/length of visits); Content (degree to which database, nor written study materials will include a group it was delivered); and Rapport (quality of visitor- identifier, though participants may indicate group assign- participant relationship) [74]. To assess Dose and Con- ment to research assistants at the12-month (T1) and 18- tent, we will adapt a home visit form used in large home month (T2) follow-ups. visiting studies, for CHALO [75] (see Additional file 1: Figure S1) to be completed after each visit. To assess re- Human subjects lationship warmth and rapport, both CHWs and This study was approved by the Albert Einstein college of mothers will complete the Working Alliance Question- Medicine’s Committee on Clinical Investigation. Bi-lingual naire [76] adapted for the study. research assistants will consent mothers in their home prior to the baseline (T0) interview. Sample size Table 3 Common Risk/Health Factor Measures Based on preliminary studies, we estimate a between Construct Variable Measure Source group difference in decline in the number of daily bottles Bottle/Sippy: Any (Y/N) 24 h recall (MSB) and sippy cups (combined) of 0.7. This equates to a small- Frequency (#/day) 24 h recall (MSB) moderate standardized effect size (Cohen’sd)of0.7/2= Added sweet/solid (Y/N) 24 h recall (MSB) 0.35. With n = 300 participants (150 per am) the trial will @ Bed or Nap (Y/N) 24 h recall (MSB) have greater than 85% power to detect an effect size of 0.35 Dietary Pattern F & V servings (#/day) 24 h recall (MSB) (two-tailed alpha = 0.05). To account for a 20% attrition rate, we will enroll 360 subjects (180 per arm). Juice & sweet drinks (#/day) 24 h recall (MSB) Analysis plan: Analyses will be intent-to-treat. Gener- Sweet & salty snack (#/day) 24 h recall (MSB) alized linear mixed models (GLMM) will be employed to Unique Obesity Physical activity Questionnaire analyze primary CRFA outcomes, as well as unique obe- Screen time Questionnaire sogenic and cariogenic outcomes. To test the impact of BMI-for-Age Z score Pediatrics visit the intervention on secondary outcomes– caries, weight Weight Velocity Z score Pediatrics visit for length, velocity of weight gain– similar GLMM models will be fit. Individuals lost to follow-up at T1 or Unique Oral Health Oral hygiene (#/day or wk) Questionnaire T2 will remain in the analytic sample. Further details are Dental visit (Y/N) Questionnaire provided below. Visible caries (Y/N) Intra-oral camera The trial’s primary outcome is frequency of combined Caries Severity (dfs index) I.O. camera sippy cup and bottle use (count/day). The intervention’s Karasz and Bonuck BMC Public Health (2018) 18:680 Page 6 of 10 effectiveness will be tested by a random-effects Poisson Family/community outreach project regression model, with the count of bottle/sippy cup as We will work with Sapna NYC, a nonprofit organization dependent variable, an indicator for study arm, a time in the Bronx that develops health interventions for SA indicator and their interaction term as fixed effects, and immigrant families, to develop an Action Group commu- a random intercept at the person level. We will adjust nity education project. Sapna has used this model in previ- for child age, given shifts in feeding behavior at this age. ous programs aimed at breast health screening, nutrition If the mean (sd) of the outcome demonstrates over -dis- and weight loss [80], and depression [81]. We will develop persion relative to a Poisson model, we will use negative two Action Groups- one in NJ and one in NY. CHWs will binomial regression instead. We will report the coeffi- recommend 12 mothers with leadership potential from cient of the interaction term, which estimates the rate the intervention to receive an 8-session training that re- ratio in bottle/sippy cup use attributable to the interven- views child health and oral health risks, as well as training tion, and its 95% confidence interval. To test the null hy- in leadership, communication, and outreach. CHWS will pothesis, we will use a z-test. lead the groups. To test the impact of the intervention on secondary out- comes (behavioral), we will use random-effect generalized Community outreach linear regression models. The intervention’s impact will be After training, the Action Groups will develop a dissemin- assessed by the coefficient of the interaction term. The esti- ation project. Elements include: 1) one-on-one outreach (in mate and its 95% confidence interval will be reported. For doctors’ offices, religious institutions, and other community secondary caries, weight for length, and velocity of weight organizations TBD). 2) Community conference/meetings at gain outcomes, logistic regression or a linear regression public libraries or other public spaces. In keeping with past model will be applied as appropriate. Anthropometrics:We projects, the Action Group will prepare outreach videos for will use WHO growth standards [77] to calculate BMI-for- community education. Particularly effective are videos that 2 2 age Z scores –weight/length (kg/m ), standardized for sex ‘tell a story’ expressing complex aspects of health behavior and actual age at measurement. We will categorize chil- and/or illustrate healthy behaviors (e.g. responsive bottle dren as “overweight” and “obese” if their BMI-for-age feeding, tooth brushing). Another strategy frequently used Z-scores exceed + 2 and + 3, respectively, as recommended in Sapna’s community education projects is the Punthi by the WHO [78], and Weight velocity Z scores: for each Path—a traditional narrative poem that ‘tells the news’ or 6 month period: 6 m. > 12 m. 12 m. > 18 m. relates key information to communities. Action Group Missing data will arise from both non-response and members will prepare a Punthi Path on child feeding for study attrition. Random bias created by missing items use at outreach events, and in the online video. will be addressed by using multiple imputations [79]. Outreach will be enhanced with a text messaging alert These will use chained equations incorporating baseline system which will allow subscribers to receive updates and end-of-study data and behavioral variables. For non- about online content, community events, and other re- random bias, sensitivity analyses will be used to impute sources. All materials will be available in multiple languages best and worst-case credible values for missing variables on an informational website developed to be culturally and then apply the original analyses to these supplemented tailored for community members, parents, families and data sets. caregivers. Data management Professional outreach project We will use REDCap (Research Electronic Data Capture) This will include a campaign targeting both clinical pro- software for database development, data entry, coding and viders in pediatrics and oral health, as well as regional secure data storage [80]. Research assistants can access and national policy makers. Our partner for this project REDCap both onsite and in the field, and enter data dir- is the South Asian Total Health Imitative (SATHI), a re- ectly as it is collected. The team will use REDCap features search and policy institute at Rutgers University. Com- to manage follow-up reminders, and adherence to T1 and ponents include: T2 windows for interview completion. All data will be maintained in secure files during and after the trial. 1) Kick off Conference. At the beginning of Year 5, SATHI will hold a half-day Global Crossroads The CHALO project phase II: Knowledge Conference focusing on SA child health, nutrition, translation campaign and oral caries. The conference will be designed to Overview attract physicians, dentists, and other care professionals. The Knowledge Translation campaign will address SA A lecture on SA immigrant health, findings from our child health disparities in our region at the community, baseline interviews, a presentation of the community institutional and policy level. health worker model and implementation experiences Karasz and Bonuck BMC Public Health (2018) 18:680 Page 7 of 10 in our RCT will be presented, along with emerging Table 4 Evaluation of Knowledge Translation results from the RCT. A mother/community member Data Type Source Collection/Management will present on her experiences and issues with feeding. Attendance & Website & event Event registration; online demographics registration surveys; Google Analytics; Workshops focusing on practical strategies—best managed in MS Access practices, handouts, oral health referrals, counseling Online training Training library Content, length, delivery checklists–will follow, with a dinner discussion at Module method; managed in the end. MS Access 2) One on one outreach. Two pediatric residents Training/event Evaluation forms Survey completion at (Montefiore Residency Program in Social Medicine/ satisfaction relevant modules; Rutgers Dept Pediatrics) will develop one-on-one managed in MS Access outreach interventions as part of their required Online marketing/ Mailing/texting/ Mail Chimp – email listserv Promotion social media lists; management and analytics; residency projects. They will make on-on-one web analytics Mobile Commons – text practice visits to physicians serving SA children in messaging campaign NJ and NY. Checklists, guidelines, patient education analytics; Google Analytics – website visit and use. materials, and handouts will be developed/adapted and provided to physicians and other practice staff. Knowledge and Pre-Posttest surveys Paper questionnaires delivered attitudes as feasible at events and 3) Traditional Media presentations. We will 1-on-1 interactions. Online disseminate information to pediatricians and dentists pre-test via Survey Monkey through write-ups in local professional publications and/or LMS; managed in MS Access and local SA media (EBC radio, TV Asia etc.). 4) Online education and social media. Late in Year 4, we will develop a website and Facebook page for the project. Educational materials and other relevant makers, and the WHO [82–84]. Despite its obvious util- materials (guidelines, best practice messages, videos, ity, the CR/HFA has only been applied in a few studies etc.) will be available on the portal, which will also [85–88]. The project described in this paper is the first serve as a core promotional hub for conferences, in the US to use this model as the basis for an interven- seminars and other activities. To facilitate knowledge tion. In keeping with the CR/HFA model, CHALO is a transfer and translation of the CHALO model to the multi-level approach. For decades, experts have advo- public health community beyond the NY Metropolitan cated a multi-level approach to addressing health dispar- Region, we will present detailed intervention protocol ities [89, 90]. Yet to date most interventions, including including staff training details, and other findings as those for ECC and obesity [91–93], still focus narrowly they emerge. RCT results will be posted in Year 5. on individual factors while ignoring interpersonal, insti- tutional and broader levels of influence [94]. CHALO, Evaluation by contrast, intervenes at each level of the SEM. Many We will track attendance, impact (as assessed through innovations, including the use of intraoral cameras, and knowledge/attitude questionnaires), and participant experi- culturally adapted dietary measurements, and a public ences. Website trafficwillbemonitored viaGoogleanalyt- education campaign that includes both traditional and ics, which will provide metrics on number of site visitors social media, have been incorporated into the design. (new and unique), time spent on the website, pages visited, CHALO represents the first test of the CR/HFA in a and as well as user demographic information, e.g. gender, clinical trial in the US. Findings will be submitted for age range, geographic location. A pop-up survey of website publication in the peer-reviewed literature. An important users may be used to capture additional information, and potential benefit of the CR/HFA approach is cost effect- material downloads will be tracked for reporting. Facebook iveness. Future research will examine whether the ap- and YouTube metrics will be captured by those sites’ ana- proach achieves the same or superior results with oral lytics tools to report views, likes, and basic user demo- health and obesity outcomes vs.conventional trials focus- graphics. Text messaging campaigns will be managed via ing on a single outcome, and will compare costs across the Mobile Commons platform, which reports on number these approaches to determine cost effectiveness of the of subscribers, cell carrier, all incoming and outgoing text CR/HFA. messages, and all links to content clicked on by subscribers. See Table 4: Evaluation of Knowledge Translation. Additional file Discussion Additional file 1: Figure S1. Example template of recommended content for the schedule of enrolment, interventions, and assessments*. The Common Risk/Health Factor Approach (CR/HFA) (DOC 49 kb) is widely promoted by oral health researchers, policy Karasz and Bonuck BMC Public Health (2018) 18:680 Page 8 of 10 Abbreviations 14. Martinson ML, McLanahan S, Brooks-Gunn J. Variation in child body mass BMI: Body mass index; CDC: Centers for Disease Control and Prevention; index patterns by race/ethnicity and maternal nativity status in the United CHW: Community health worker; CR/HFA: Common risk/health factor States and England. Matern Child Health J. 2015;19(2):373–80. approach; ECC: Early childhood carries; EUC: Enhanced usual care; 15. Bedi R, Uppal RD. The oral health of minority ethnic communities in the MSB: MySmileBuddy; NJ: New Jersey; NY: New York; RCT: Randomized United Kingdom. Br Dent J. 1995;179(11–12):421–5. controlled trial; SA: South Asian; UK: United Kingdom; US: United States; 16. Wong F. Epidemiology: inequalities in oral health for deprived multiethnic WHO: World Health Organization communities. Br Dent J. 2000;189(2):84–4. 17. Prendergast MJ, Beal JF, Williams SA. The relationship between deprivation, Funding ethnicity and dental health in 5-year-old children in Leeds, UK. Community This work was supported by grant from the National Institute on Minority Dent Health. 1997;14(1):18. Health and Health Disparities (R01MD010460) to Drs. Karasz and Bonuck. 18. Gray M, Morris AJ, Davies J. The oral health of south Asian five-year-old children in deprived areas of Dudley compared with white children of equal Availability of data and materials deprivation and fluoridation status. Community Dent Health. 2000;17(4):243–5. NA, this is a study protocol. 19. Yin HS, Sanders LM, Rothman RL, Shustak R, Eden SK, Shintani A, Cerra ME, Cruzatte EF, Perrin EM. Parent health literacy and "obesogenic" feeding and Authors’ contributions physical activity-related infant care behaviors. J Pediatr. 2014;164(3):577–83. e571 KB and AK contributed to all phases of the manuscript, from conceptualization, 20. Bonuck K, Kahn R, Schechter C. Is late bottle-weaning associated with overweight to drafting and revision. Both authors read and approved the final manuscript. in young children? Analysis of NHANES III data. Clin Pediatr. 2004;43(6):535–40. 21. Gooze RA, Anderson SE, Whitaker RC. Prolonged bottle use and obesity at 5. Ethics approval and consent to participate 5 years of age in US children. J Pediatr. 2011;159(3):431–6. This study was approved by the Einstein Committee on Clinical 22. Kimbro RT, Brooks-Gunn J, McLanahan S. Racial and ethnic differentials in Investigations, IRB # 2016–6156. overweight and obesity among 3-year-old children. Am J Public Health. 2007;97(2):298–305. Consent for publication 23. Behrendt A, Sziegoleit F, Muler-Lessmann V, Ipek-Ozdemir G, Wetzel WE. 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Reducing pediatric caries and obesity risk in South Asian immigrants: randomized controlled trial of common health/risk factor approach

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Medicine & Public Health; Public Health; Medicine/Public Health, general; Epidemiology; Environmental Health; Biostatistics; Vaccine
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Abstract

Background: This paper describes the design and methods of a multi-phase study to reduce early childhood caries and obesity in vulnerable South Asian (SA) immigrants in the United States. Early childhood caries and obesity are the most common diseases of early childhood. Risk factors for both diseases are rooted in early childhood feeding practices such as bottle feeding and intake of sweets and sweetened beverages. The Common Health/Risk Factor Approach to addressing oral health is widely promoted by the WHO and other policy makers. This approach recognizes links between oral health and other diseases of modernity. Our CHALO! (“Child Health Action to Lower Obesity and Oral health risk”–from a Hindi word meaning "Let's go!") study targets SA families at high risk for early childhood caries and obesity. CHALO! addresses common risk factors associated with these two common diseases of childhood. Methods: This two part project includes a randomized controlled trial, and a Knowledge Translation campaign. A randomized controlled trial will enroll n = 360 families from pediatric practices serving South Asians in the New York metro area. The intervention group will receive home visits by SA community health workers at 6, 8, 10, 12, 14, and 16 months of age. Controls will receive culturally tailored educational material. Primary outcomes– cariogenic and obesogenic feeding practices at 6, 12, and 18 months– will be assessed with the MySmileBuddy iPad based tool. Secondary outcomes include: oral hygiene practices, anthropometrics, and caries incidence at 18 months. A public education campaign will focus on both families and health care providers. Discussion: There are few Common Health/Risk Factor Approach published studies on obesity and oral health risk in children, despite health morbidity and costs associated with both conditions. CHALO! comprises a multi- level interventions designed to promote culturally competent, sustainable change. Trial registration: ClinicalTrials.gov NCT03077425. Keywords: Obesity, Oral health, Caries, Children, Common risk factor approach, South Asian * Correspondence: alison.karasz@einstein.yu.edu Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, New York 10461, USA © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Karasz and Bonuck BMC Public Health (2018) 18:680 Page 2 of 10 Background Bottle use beyond 12–15 months increases risk for both Immigrants from the developing world are impacted by conditions [20–26], as do bottles at night or naptime [22] the global nutrition transition, from low calorie, highly or bottles that contain solids [27] and sweeteners [28]. nutritious foods in resource-poor environments, to the Bottle feeding facilitates overriding of a child’sinternal sa- high calorie, low nutrition diets of the west [1]. Nutrition- tiety cues, [29] thereby reducing ability to self-regulate in- related diseases occur with the adoption of western diets. take [30]. This may further promote both weight gain [31, Obesity and oral caries, the most common diseases of 32] and early childhood caries (ECC) [24]. early childhood in western societies, are prevalent in low Such feeding practices are common in SA communities income immigrant communities [2–4]. The Child Health [33, 34]. Up to 75% of low-income SA 15-month olds still Action to Lower risk of Obesity and Oral caries–CHALO! use a bottle, and 30% regularly drink sweetened milk (“let’sgo!” in Hindi)– is a multi-level intervention cultur- [35–37]. Non-responsive feeding is also common in SA ally tailored for at-risk immigrant South Asians (SAs) from families. Non-responsive feeding’s defining feature is India, Pakistan, and Bangladesh. These SAs are among the caregiver lack of responsiveness to a child’s feeding cues. fastest growing immigrant groups in the US [5, 6]. It includes both adult controlling (forcing or restricting) SAs are particularly vulnerable to nutrition-related and child controlling (indulgent) feeding [38]. Forcing/ disease. A modernizing diet in urban South Asian has controlling feeding leads to rapid weight gain in the first created a public health ‘tsunami’ of obesity and metabolic year of life, which predispose to overweight in later years disorders in that region [7–9]. SA immigrants in the UK [39, 40]. Indulgent styles are associated with obesity in and Canada bear a high burden of obesity-related health toddlers and older children [41]. Among SAs in the New disparities [10–12]. SA immigrant children demonstrate York area, ‘force feeding’ is routine. Once children are old growth patterns associated with metabolic risk: low birth- enough to ask for food, force-feeding yields to indulgent weight followed by steep weight gain in infancy and child- feeding. SA mothers fear distressing their children by re- hood [13]. A tendency towards central adiposity places fusing food [42]. adults and children at high risk for metabolic syndrome In addition to common risk behaviors, there are unique even controlling for body mass index (BMI) [9, 14]. Chil- risk behaviors associated with obesity and caries that are dren are also at high risk for early childhood caries (ECC) common among SA immigrants. SA children are more [15–17], even adjusting for socio-economic status s [18]. sedentary than their white counterparts, raising their risk of obesity [43–46]. Oral health prevention—e.g., brushing, The common risk factor approach oral hygiene, and preventive dental care—are undervalued The Common Risk/Health Factor Approach (CR/HFA) to in SA communities. Many families seek dental care only oral health disparities focuses on risk factors and underlying when there is pain or visible decay; baby teeth may be social determinants shared with other diseases of modernity viewed as dispensable [42, 47, 48]. [19]. Based on the CR/HFA, CHALO! employs a multi- level social-ecological framework for conceptualizing and Interpersonal level influences addressing oral health and obesity risk (See Table 1): SA married women’s low status and limited access to family decision-making may impede adherence to medical advice Individual level influences [42]. Senior family members may insist traditional feeding Maternal feeding practices in early life increase the risk patterns including frequent sweets and delayed weaning of caries (i.e., cariogenic) and obesity (i.e., obesogenic). [37, 42]. Maternal depression—due to factors such as They include: prolonged use of bottles (and ‘sippy cups’); poverty, isolation, and marital abuse—is common in SA adding solids and sweets to bottles; nighttime feeding; families [49–51]. Maternal depression is associated with salty and starchy snacks; sweets, and sweetened beverages. non-responsive feeding [52, 53]and childobesity [41]. Table 1 Outline CHALO Multi Level Intervention Activity Target Level Home Visit with Mothers Knowledge, support, wellbeing, confidence, skills, feeding behaviors Individual Home Visits with Families Family/household support for Mothers’ Goals Interpersonal Dental Referral & Navigation Link families to providers; facilitate appointments Organizational Knowledge Translation –Community Raise awareness & educate via: 1-to-1 outreach, Community local meetings, video/drama Professional Dissemination Educate local providers on AAP & AAPD policy; Community & Policy raise cultural awareness; promote professionals- researcher-policymaker dialogue Karasz and Bonuck BMC Public Health (2018) 18:680 Page 3 of 10 Poverty and its sequelae, including substandard housing, The CHALO project RCT further limit mothers’ ability to change feeding patterns. Methods Such may cause disruption and crying, which may be diffi- To address individual and interpersonal (i.e., household) cult to tolerate in crowded living quarters [42]. risk factors, SA community health workers (CHWs) will conduct a home-visiting intervention. Home Visiting is a Institutional/organizational level influences decades-old strategy to improve maternal-child health Like other low-income immigrants, SA children lack access outcomes [63–65] by empowering families. We will recruit to dental care [4, 54, 55]. Pediatricians rarely refer to den- low-income SA mother-child dyads from pediatric practices tists [4, 54–57]. Guidelines recommend a first dental visit in New York City and New Jersey (U.S.). Inclusion cri- by 12 months of age and two visits per year for low-income teria include: a) Age: Child is < 6 months old at time of re- and immigrant children [58, 59]. Yet only 1.5% of one-year cruitment; b) Insurance: Child is enrolled in either olds visit a dentist each year [60] and rates are lowest in Medicaid or the Children’s Health Insurance Program; poor families who could most benefit [61]. Another barrier c) Nativity: Mother was born in India, Pakistan, or to care for low income children is the fact that many den- Bangladesh); d) Language:Motherspeaksstandard Ben- tists on the US don’t accept Medicaid or Children’sHealth gali, English or Hindi/Urdu; e) Agency:Mother isindex Insurance Program coverage [62]. child’s primary caretaker. Exclusion criteria include: a) In- ability to provide informed consent; b) Plans to travel for > Community level influences 1 month during follow-up, and; c) child health condition These include cultural beliefs and practices, along with barring participation (per pediatrician review). low awareness of risk factors. Though concerns over child feeding are widely shared among SA mothers, there Enhanced usual care (control) is relatively little understanding of how non-responsive An EUC counseling intervention will be delivered imme- feeding leads to child food refusal, creating a vicious cycle diately following the T0 Baseline Interview, just prior to of increased maternal anxiety and force feeding. One SA randomization. EUC Components include: 1) a pamphlet- mother on www.indusladies.com, a website for South Asian containing basic ECC and Obesity prevention messages, moms, asks: "Why do American kids happily feed them- and 2) Dental Referrals. We developed a Screened Dental selves from the age of one year old and are constantly ask- Provider list of dentists who: a) are willing to see 12 month ing for food? Why do Indian kids hate food and need to be old children; and b) accept most insurance plans in the FORCE FED until the age of 4,5,6, or even 7?" Pediatricians study practices. in the SA community often report frustration. “Feeding problems take up 75% of my time.” (Mehotra N, SAPPHIRE Intervention network pediatrician. In.; 2015, personal communication). CHWs will conduct n = 6 home visits when the child is 6, Physicians lack tools and support needed to address this 8, 10, 12, 14, and 16 months old. Of these, 4 visits include problem. “Themostcommonlyprescribedmedicationinmy only the mother-child dyad. Visits at 8 and 14 months will practice is an appetite stimulant. Even though the child include a senior family decision maker (e.g., husband or doesn’t need it, I have to prescribe to get peace in the fam- mother-in-law). CHWs will conduct 6 follow up telephone ily.” (Mehotra N. In.; 2015, personal communication). calls in alternate months. Calls will be used to ask about the family’s goals for change, gauge progress, and assist Policy level influences with trouble shooting. The Knowledge Translation campaign will work with Mother-only visits will focus on building rapport and private practitioners, residents, and teaching faculty in intimacy, identifying family/household concerns, review- dental and pediatric departments. Through dialogue and ing risk/health behaviors, reviewing, setting, and trouble- presentations in clinical and educational settings, the shooting goals, building skills through active interaction goal is to develop new best practices and guidelines re- with the child, and providing education. Messages will garding the improved care of South Asian immigrant be provided orally and via culturally tailored, attractive children. educational materials. To bolster mothers’ skills, CHW- The randomized controlled trial (RCT), CHALO! will guided interactions with the dyads will include: recogniz- answer the following research questions: a) Does a ing infant satiety and hunger cues via responsive bottle culturally-tailored CR/HFA home-visiting intervention, feeding, preparing age-appropriate self-feeding foods, en- from child age 6 through 16 months, reduce cariogenic couraging tummy time and active play, transitioning from and obesogenic behaviors in SA immigrant families (pri- naptime milk to water bottles, and oral hygiene practices mary hypothesis)? b) Is this CR/HFA intervention asso- such as tooth brushing. At each visit, the CHW encour- ciated with reduced incidence of oral caries and obesity ages the mother to set a concrete, manageable behavior at 18 months of age (secondary hypothesis)? change goal. Patient navigation, as needed, will encourage Karasz and Bonuck BMC Public Health (2018) 18:680 Page 4 of 10 mothers to make and keep two dental visits for their child, color photographs of food and beverage groupings. Prior over the 12 month follow-up. Family visits will, similarly, to administration, the research assistant will ask whether assess family views on barriers to change, and enlist sup- the prior 24 h represented a ‘usual day.’ If not, participants port for mothers’ child feeding goals (Fig. 1). will conduct a recall for one day earlier. We will conduct a second 24-h recall for a subset of participants. Outcomes measurement: Unique risk factors for obesity (sedentary behavior/ The RCT’s primary aim is to reduce risk behaviors for screen time) will be assessed through previously vali- caries and obesity. We hypothesize that relative to Controls, dated questionnaire items used in other large studies. the Intervention group will report: less bottle use (any, with Unique ECC-risk factors include dental visits and oral added sweeteners/solids, at nap and bedtimes), improved hygiene practices. We will assess frequency of tooth food choices (more fruits and vegetables, less juice and brushing, use of toothpaste, and use of tap water using sweetened beverages, fewer sweet and salty snacks); items from a measure developed by the CDC. Dental more physical activity and less screen time; and more health utilization will be assessed through questions at tooth brushing and dental visits. See Table 2 for Schedule T1 and T2. of Research Assessments. The RCT’s secondary aim is to reduce the velocity of weight gain in months 12–18, and the incidence of oral Common risk factor feeding behaviors caries at 18 months. Weight and length data will be We will use MySmileBuddy (MSB), an iPad based ECC collected by research assistants at the T0, T1, and T2 risk assessment and educational tool [66]. MSB was val- outcomes assessments. Study pediatricians will train re- idated in previous research [67]. The MSB guides parents search staff in anthropometrics protocol. For length, through a modified 24-h dietary recall for their child. We two supine measures will be taken using infantometers have adapted the MSB to reflect culturally appropriate SA (Seca 417, Brooklyn NY), to the nearest 0.1 cm. For foods and beverages, as well as the types of bottles and weight, children will be measured with diaper and light cups used for beverages. Participants are cued by queries clothing. ECC will be assessed by study staff using (e.g., first thing to eat or drink upon waking) and attractive Intraoral cameras at the 18 month follow-up. Intraoral Fig. 1 Study flow Karasz and Bonuck BMC Public Health (2018) 18:680 Page 5 of 10 Table 2 Schedule of Research Assessments: 6, 12, and 18 Months Recruitment and retention Practices will generate quarterly lists of 2–5 month olds Interview Data Obtained Setting seen for well-child visits. Parents will receive an “opt-out” Baseline @ 6 mos. Questionnaires Home (T0) letter from the pediatrician when their child is 4–5 months MySmileBuddy (MSB) old, with a number to call to decline study contact. Par- Weight/length ents who do not decline will be contacted by study staff to 12 mo. Interview Questionnaires Home arrange a Baseline (T0) interview. We will set individual (T1) MySmileBuddy (MSB) practice target recruitment rates based on target popula- Weight/length tion size at each practice. Strategies to promote retention include: gift card incentives for research interviews, quar- 18 mo. Interview Questionnaires Home (T2) terly post-card reminders and incentives to notify study of MySmileBuddy (MSB) address or name changes, holiday greeting postcards, and Caries Exam reminders for upcoming interviews. Weight/length Randomization and masking cameras are valid [68–72] and acceptable [73]inyoung Participants will be randomized 1:1 to the intervention children. Images will be transmitted to pediatric den- or EUC control group, after providing informed consent tists at the Kodiak who will determine the presence of (see below). Following delivery of the EUC at the T0 (base- visible dental caries and (if any) their severity (Table 3). line) assessment, the CHW will randomize participants by opening a sealed envelope containing the random assign- ment (prepared in advance by the project statistician). This Implementation/Fidelity sequence preserves masking of outcomes assessment at the Home visiting interventions involve three components: T0 interview. Neither the outcomes section of the study Dose (timing/length of visits); Content (degree to which database, nor written study materials will include a group it was delivered); and Rapport (quality of visitor- identifier, though participants may indicate group assign- participant relationship) [74]. To assess Dose and Con- ment to research assistants at the12-month (T1) and 18- tent, we will adapt a home visit form used in large home month (T2) follow-ups. visiting studies, for CHALO [75] (see Additional file 1: Figure S1) to be completed after each visit. To assess re- Human subjects lationship warmth and rapport, both CHWs and This study was approved by the Albert Einstein college of mothers will complete the Working Alliance Question- Medicine’s Committee on Clinical Investigation. Bi-lingual naire [76] adapted for the study. research assistants will consent mothers in their home prior to the baseline (T0) interview. Sample size Table 3 Common Risk/Health Factor Measures Based on preliminary studies, we estimate a between Construct Variable Measure Source group difference in decline in the number of daily bottles Bottle/Sippy: Any (Y/N) 24 h recall (MSB) and sippy cups (combined) of 0.7. This equates to a small- Frequency (#/day) 24 h recall (MSB) moderate standardized effect size (Cohen’sd)of0.7/2= Added sweet/solid (Y/N) 24 h recall (MSB) 0.35. With n = 300 participants (150 per am) the trial will @ Bed or Nap (Y/N) 24 h recall (MSB) have greater than 85% power to detect an effect size of 0.35 Dietary Pattern F & V servings (#/day) 24 h recall (MSB) (two-tailed alpha = 0.05). To account for a 20% attrition rate, we will enroll 360 subjects (180 per arm). Juice & sweet drinks (#/day) 24 h recall (MSB) Analysis plan: Analyses will be intent-to-treat. Gener- Sweet & salty snack (#/day) 24 h recall (MSB) alized linear mixed models (GLMM) will be employed to Unique Obesity Physical activity Questionnaire analyze primary CRFA outcomes, as well as unique obe- Screen time Questionnaire sogenic and cariogenic outcomes. To test the impact of BMI-for-Age Z score Pediatrics visit the intervention on secondary outcomes– caries, weight Weight Velocity Z score Pediatrics visit for length, velocity of weight gain– similar GLMM models will be fit. Individuals lost to follow-up at T1 or Unique Oral Health Oral hygiene (#/day or wk) Questionnaire T2 will remain in the analytic sample. Further details are Dental visit (Y/N) Questionnaire provided below. Visible caries (Y/N) Intra-oral camera The trial’s primary outcome is frequency of combined Caries Severity (dfs index) I.O. camera sippy cup and bottle use (count/day). The intervention’s Karasz and Bonuck BMC Public Health (2018) 18:680 Page 6 of 10 effectiveness will be tested by a random-effects Poisson Family/community outreach project regression model, with the count of bottle/sippy cup as We will work with Sapna NYC, a nonprofit organization dependent variable, an indicator for study arm, a time in the Bronx that develops health interventions for SA indicator and their interaction term as fixed effects, and immigrant families, to develop an Action Group commu- a random intercept at the person level. We will adjust nity education project. Sapna has used this model in previ- for child age, given shifts in feeding behavior at this age. ous programs aimed at breast health screening, nutrition If the mean (sd) of the outcome demonstrates over -dis- and weight loss [80], and depression [81]. We will develop persion relative to a Poisson model, we will use negative two Action Groups- one in NJ and one in NY. CHWs will binomial regression instead. We will report the coeffi- recommend 12 mothers with leadership potential from cient of the interaction term, which estimates the rate the intervention to receive an 8-session training that re- ratio in bottle/sippy cup use attributable to the interven- views child health and oral health risks, as well as training tion, and its 95% confidence interval. To test the null hy- in leadership, communication, and outreach. CHWS will pothesis, we will use a z-test. lead the groups. To test the impact of the intervention on secondary out- comes (behavioral), we will use random-effect generalized Community outreach linear regression models. The intervention’s impact will be After training, the Action Groups will develop a dissemin- assessed by the coefficient of the interaction term. The esti- ation project. Elements include: 1) one-on-one outreach (in mate and its 95% confidence interval will be reported. For doctors’ offices, religious institutions, and other community secondary caries, weight for length, and velocity of weight organizations TBD). 2) Community conference/meetings at gain outcomes, logistic regression or a linear regression public libraries or other public spaces. In keeping with past model will be applied as appropriate. Anthropometrics:We projects, the Action Group will prepare outreach videos for will use WHO growth standards [77] to calculate BMI-for- community education. Particularly effective are videos that 2 2 age Z scores –weight/length (kg/m ), standardized for sex ‘tell a story’ expressing complex aspects of health behavior and actual age at measurement. We will categorize chil- and/or illustrate healthy behaviors (e.g. responsive bottle dren as “overweight” and “obese” if their BMI-for-age feeding, tooth brushing). Another strategy frequently used Z-scores exceed + 2 and + 3, respectively, as recommended in Sapna’s community education projects is the Punthi by the WHO [78], and Weight velocity Z scores: for each Path—a traditional narrative poem that ‘tells the news’ or 6 month period: 6 m. > 12 m. 12 m. > 18 m. relates key information to communities. Action Group Missing data will arise from both non-response and members will prepare a Punthi Path on child feeding for study attrition. Random bias created by missing items use at outreach events, and in the online video. will be addressed by using multiple imputations [79]. Outreach will be enhanced with a text messaging alert These will use chained equations incorporating baseline system which will allow subscribers to receive updates and end-of-study data and behavioral variables. For non- about online content, community events, and other re- random bias, sensitivity analyses will be used to impute sources. All materials will be available in multiple languages best and worst-case credible values for missing variables on an informational website developed to be culturally and then apply the original analyses to these supplemented tailored for community members, parents, families and data sets. caregivers. Data management Professional outreach project We will use REDCap (Research Electronic Data Capture) This will include a campaign targeting both clinical pro- software for database development, data entry, coding and viders in pediatrics and oral health, as well as regional secure data storage [80]. Research assistants can access and national policy makers. Our partner for this project REDCap both onsite and in the field, and enter data dir- is the South Asian Total Health Imitative (SATHI), a re- ectly as it is collected. The team will use REDCap features search and policy institute at Rutgers University. Com- to manage follow-up reminders, and adherence to T1 and ponents include: T2 windows for interview completion. All data will be maintained in secure files during and after the trial. 1) Kick off Conference. At the beginning of Year 5, SATHI will hold a half-day Global Crossroads The CHALO project phase II: Knowledge Conference focusing on SA child health, nutrition, translation campaign and oral caries. The conference will be designed to Overview attract physicians, dentists, and other care professionals. The Knowledge Translation campaign will address SA A lecture on SA immigrant health, findings from our child health disparities in our region at the community, baseline interviews, a presentation of the community institutional and policy level. health worker model and implementation experiences Karasz and Bonuck BMC Public Health (2018) 18:680 Page 7 of 10 in our RCT will be presented, along with emerging Table 4 Evaluation of Knowledge Translation results from the RCT. A mother/community member Data Type Source Collection/Management will present on her experiences and issues with feeding. Attendance & Website & event Event registration; online demographics registration surveys; Google Analytics; Workshops focusing on practical strategies—best managed in MS Access practices, handouts, oral health referrals, counseling Online training Training library Content, length, delivery checklists–will follow, with a dinner discussion at Module method; managed in the end. MS Access 2) One on one outreach. Two pediatric residents Training/event Evaluation forms Survey completion at (Montefiore Residency Program in Social Medicine/ satisfaction relevant modules; Rutgers Dept Pediatrics) will develop one-on-one managed in MS Access outreach interventions as part of their required Online marketing/ Mailing/texting/ Mail Chimp – email listserv Promotion social media lists; management and analytics; residency projects. They will make on-on-one web analytics Mobile Commons – text practice visits to physicians serving SA children in messaging campaign NJ and NY. Checklists, guidelines, patient education analytics; Google Analytics – website visit and use. materials, and handouts will be developed/adapted and provided to physicians and other practice staff. Knowledge and Pre-Posttest surveys Paper questionnaires delivered attitudes as feasible at events and 3) Traditional Media presentations. We will 1-on-1 interactions. Online disseminate information to pediatricians and dentists pre-test via Survey Monkey through write-ups in local professional publications and/or LMS; managed in MS Access and local SA media (EBC radio, TV Asia etc.). 4) Online education and social media. Late in Year 4, we will develop a website and Facebook page for the project. Educational materials and other relevant makers, and the WHO [82–84]. Despite its obvious util- materials (guidelines, best practice messages, videos, ity, the CR/HFA has only been applied in a few studies etc.) will be available on the portal, which will also [85–88]. The project described in this paper is the first serve as a core promotional hub for conferences, in the US to use this model as the basis for an interven- seminars and other activities. To facilitate knowledge tion. In keeping with the CR/HFA model, CHALO is a transfer and translation of the CHALO model to the multi-level approach. For decades, experts have advo- public health community beyond the NY Metropolitan cated a multi-level approach to addressing health dispar- Region, we will present detailed intervention protocol ities [89, 90]. Yet to date most interventions, including including staff training details, and other findings as those for ECC and obesity [91–93], still focus narrowly they emerge. RCT results will be posted in Year 5. on individual factors while ignoring interpersonal, insti- tutional and broader levels of influence [94]. CHALO, Evaluation by contrast, intervenes at each level of the SEM. Many We will track attendance, impact (as assessed through innovations, including the use of intraoral cameras, and knowledge/attitude questionnaires), and participant experi- culturally adapted dietary measurements, and a public ences. Website trafficwillbemonitored viaGoogleanalyt- education campaign that includes both traditional and ics, which will provide metrics on number of site visitors social media, have been incorporated into the design. (new and unique), time spent on the website, pages visited, CHALO represents the first test of the CR/HFA in a and as well as user demographic information, e.g. gender, clinical trial in the US. Findings will be submitted for age range, geographic location. A pop-up survey of website publication in the peer-reviewed literature. An important users may be used to capture additional information, and potential benefit of the CR/HFA approach is cost effect- material downloads will be tracked for reporting. Facebook iveness. Future research will examine whether the ap- and YouTube metrics will be captured by those sites’ ana- proach achieves the same or superior results with oral lytics tools to report views, likes, and basic user demo- health and obesity outcomes vs.conventional trials focus- graphics. Text messaging campaigns will be managed via ing on a single outcome, and will compare costs across the Mobile Commons platform, which reports on number these approaches to determine cost effectiveness of the of subscribers, cell carrier, all incoming and outgoing text CR/HFA. messages, and all links to content clicked on by subscribers. See Table 4: Evaluation of Knowledge Translation. Additional file Discussion Additional file 1: Figure S1. Example template of recommended content for the schedule of enrolment, interventions, and assessments*. The Common Risk/Health Factor Approach (CR/HFA) (DOC 49 kb) is widely promoted by oral health researchers, policy Karasz and Bonuck BMC Public Health (2018) 18:680 Page 8 of 10 Abbreviations 14. Martinson ML, McLanahan S, Brooks-Gunn J. Variation in child body mass BMI: Body mass index; CDC: Centers for Disease Control and Prevention; index patterns by race/ethnicity and maternal nativity status in the United CHW: Community health worker; CR/HFA: Common risk/health factor States and England. Matern Child Health J. 2015;19(2):373–80. approach; ECC: Early childhood carries; EUC: Enhanced usual care; 15. Bedi R, Uppal RD. The oral health of minority ethnic communities in the MSB: MySmileBuddy; NJ: New Jersey; NY: New York; RCT: Randomized United Kingdom. Br Dent J. 1995;179(11–12):421–5. controlled trial; SA: South Asian; UK: United Kingdom; US: United States; 16. Wong F. Epidemiology: inequalities in oral health for deprived multiethnic WHO: World Health Organization communities. Br Dent J. 2000;189(2):84–4. 17. Prendergast MJ, Beal JF, Williams SA. The relationship between deprivation, Funding ethnicity and dental health in 5-year-old children in Leeds, UK. Community This work was supported by grant from the National Institute on Minority Dent Health. 1997;14(1):18. Health and Health Disparities (R01MD010460) to Drs. Karasz and Bonuck. 18. Gray M, Morris AJ, Davies J. The oral health of south Asian five-year-old children in deprived areas of Dudley compared with white children of equal Availability of data and materials deprivation and fluoridation status. Community Dent Health. 2000;17(4):243–5. NA, this is a study protocol. 19. Yin HS, Sanders LM, Rothman RL, Shustak R, Eden SK, Shintani A, Cerra ME, Cruzatte EF, Perrin EM. Parent health literacy and "obesogenic" feeding and Authors’ contributions physical activity-related infant care behaviors. J Pediatr. 2014;164(3):577–83. e571 KB and AK contributed to all phases of the manuscript, from conceptualization, 20. Bonuck K, Kahn R, Schechter C. Is late bottle-weaning associated with overweight to drafting and revision. Both authors read and approved the final manuscript. in young children? Analysis of NHANES III data. Clin Pediatr. 2004;43(6):535–40. 21. Gooze RA, Anderson SE, Whitaker RC. Prolonged bottle use and obesity at 5. Ethics approval and consent to participate 5 years of age in US children. J Pediatr. 2011;159(3):431–6. This study was approved by the Einstein Committee on Clinical 22. Kimbro RT, Brooks-Gunn J, McLanahan S. Racial and ethnic differentials in Investigations, IRB # 2016–6156. overweight and obesity among 3-year-old children. Am J Public Health. 2007;97(2):298–305. Consent for publication 23. Behrendt A, Sziegoleit F, Muler-Lessmann V, Ipek-Ozdemir G, Wetzel WE. 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Journal

BMC Public HealthSpringer Journals

Published: May 31, 2018

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