Background: Pregnancy is a time of high risk for excessive weight gain, leading to health-related consequences for mothers and offspring. Theory-based obesity interventions that target proposed mechanisms of biobehavioral change are needed, in addition to simply providing nutritional and weight gain directives. Mindfulness training is hypothesized to reduce stress and non-homeostatic eating behaviors – or eating for reasons other than hunger or caloric need. We developed a mindfulness-based intervention for high-risk, low-income overweight pregnant women over a series of iterative waves using the Obesity-Related Behavioral Intervention Trials (ORBIT) model of intervention development, and tested its effects on stress and eating behaviors. Methods: Overweight pregnant women (n = 110) in their second trimester were enrolled in an 8-week group intervention. Feasibility, acceptability, and facilitator fidelity were assessed, as well as stress, depression and eating behaviors before and after the intervention. We also examined whether pre-to-post intervention changes in outcomes of well-being and eating behaviors were associated with changes in proposed mechanisms of mindfulness, acceptance, and emotion regulation. Results: Participants attended a mean of 5.7 sessions (median = 7) out of 8 sessions total, and facilitator fidelity was very good. Of the women who completed class evaluations, at least half reported that each of the three class components (mindful breathing, mindful eating, and mindful movement) were “very useful,” and that they used them on most days at least once a day or more. Women improved in reported levels of mindfulness, acceptance, and emotion regulation, and these increases were correlated with reductions in stress, depression, and overeating. Conclusions: These findings suggest that in pregnant women at high risk for excessive weight gain, it is both feasible and effective to use mindfulness strategies taught in a group format. Further, increases in certain mindfulness skills may help with better management of stress and overeating during pregnancy. Trial registration: ClinicalTrials.gov NCT01307683, March 8, 2011. Keywords: Pregnancy, Obesity, Stress, Depression, Acceptance-based coping, Emotion regulation, Gestational weight gain, Behavioral intervention, Mindfulness, Mindful motherhood training * Correspondence: firstname.lastname@example.org California Pacific Medical Center Research Institute, 475 Brannan Street, San Francisco, CA 94120, USA Institute of Noetic Sciences, 625 Second Street, # 200, Petaluma, CA 94952, USA Full list of author information is available at the end of the article © 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. Vieten et al. BMC Pregnancy and Childbirth (2018) 18:201 Page 2 of 14 Background Current dietary approaches to healthy weight gain dur- Obesity is a leading public health concern in the United ing pregnancy focus almost exclusively on nutrition edu- States . In 2013–2014, the prevalence of overall obes- cation and individual control of food intake . ity (body mass index [BMI] ≥30) was 40.4% among adult Programs based solely on nutritional recommendations women, and 9.9% for class 3 obesity (BMI ≥40), with a have limited success in preventing excessive gestational significant linear increase over time between 2005 and weight gain [25, 26], perhaps because they rarely address 2013–2014 . The prevalence of obesity for black (57. the root causes of the strong drive to overeat. A success- 2%) and Latina/Hispanic (46.9%) women far exceeds that ful program to address excessive weight gain during of white women (38.7%). Women who are already over- pregnancy must also integrate behavioral strategies for weight or obese before pregnancy have greater risk for managing appetitive drive, knowledge of the psychology gestational weight gain greater than the recommended of eating and behavior change, and the neuroscience of 15–25 pounds, or 11–20 pounds, respectively . stress, appetite, and reward. Both pre-pregnancy obesity and excessive maternal Mindfulness-based interventions are receiving increas- weight gain during pregnancy are associated with a num- ing attention and empirical support for reducing stress ber of unfavorable outcomes. Obesity during pregnancy and addressing stress-related medical problems and be- increases risks of antenatal obstetric problems, caesarean haviors [27–29]. Mindfulness skills may be important for delivery, and fetal risks  and gestational weight gain in combating non-homeostatic eating in three ways. First, excess of IOM guidelines has been linked to neonatal stress is a fundamental but sometimes overlooked factor complications [5, 6]. Excessive weight gain during preg- that both predicts and interacts with eating behaviors to nancy is also directly associated with increased BMI and increase risk for obesity. Mindfulness skills can target risk of obesity in offspring into adolescence . Current the stress-eating interaction because they are effective studies suggest that obese women gaining no or low gesta- for reducing anxiety, depression, and stress [30, 31], tional weight have better health outcomes . Pregnancy which should in turn help to reduce stress-eating. Sec- may be a unique opportunity to positively influence a ond, the psychological causes of emotional eating are be- woman’s weight gain trajectory by offering low-cost, feas- lieved to involve poor awareness of internal ible, and effective interventions that could reduce health physiological states and differentiation of hunger cues risks for both mother and child. and emotional arousal [32, 33]. Mindfulness increases at- Obesity and weight gain cannot be remedied through tention to and awareness of internal sensations, which a simplistic approach to reducing caloric intake. Food, may help individuals develop a heightened ability to dif- medications, physical inactivity, toxins, and viruses inter- ferentiate hunger cues from emotion responses, and de- act with genetics to interfere with energy balance and tect and respond to satiety cues. Consequently, the contribute to obesity . Weight gain is fostered in some frequency of binge eating can be reduced [34–37]. Third, by non-homeostatic eating (defined as eating reflexively mindfulness practices are aimed at increasing attention in response to factors other than caloric need or hunger) to and awareness of thoughts and emotions. Emotional , and includes mindless eating, reward-based eating, and eating is thought to be a self-regulation process, where stress eating [10–12], which are especially common dur- one’s attention is shifted away from negative affect or ing periods of chronic stress [13–15]. The drive to eat negative self-appraisals towards an immediately available non-homeostatically is primed by strong neurobiological reward-stimulus such as food [38, 39]. Mindfulness allows signals involving reward and stress systems . For ex- individuals to gain awareness of, acknowledge, and toler- ample, palatability of high fat and sweet foods is height- ate their internal states without immediately responding ened with stress  by increasing cortisol, which in to them, thus possibly reducing their need to shift their at- turn stimulates dopamine activity. Secretion of stress- tention to food. At the same time, these practices may fa- related glucocorticoids also increases motivation for food cilitate awareness of the thoughts and feelings that trigger and secretion of insulin, which promotes food intake emotional eating. In addition, mindfulness-based interven- and obesity . This pattern is reflects what has been tions are short-term, low-cost, and feasible to integrate observed in animal studies on the neurobiology of addic- into standard prenatal care [40–42]. tion and drug abuse [18, 19]. The aim of this project was to develop a psychoeduca- Maternal obesity during pregnancy confers increased tional intervention for overweight or obese pregnant risk of her child becoming overweight through a number women to encourage better nutrition and healthy weight of biopsychosocial mechanisms such as maternal and gain during pregnancy by teaching mindfulness skills for fetal hyperglycemia and hyperinsulinemia , stress- stress reduction integrated with nutritional and exercise induced excessive gestational weight gain [21, 22], and recommendations. The overall project utilized the stress-induced epigenetic changes leading to offspring Obesity-Related Behavioral Intervention Trials (ORBIT) fat storage and obesity . model for developing behavioral treatments to prevent Vieten et al. BMC Pregnancy and Childbirth (2018) 18:201 Page 3 of 14 and/or manage chronic disease . Our specific model and progressive process, with clinically relevant mile- (see Fig. 1) was that women enter into pregnancy with a stones for forward movement and return to earlier diverse array of factors influencing pre-pregnancy weight stages for refinement and optimization. and nutrition, including life stressors and stress- The MAMAS study began with focus groups with resilience, food security/availability, and eating behavior overweight and obese pregnant women (n = 59) repre- patterns. We hypothesized that the Mindful Moms sentative of the target population to assess interest in, Training (MMT) would, through increasing mindfulness and identify potential barriers to, participating in a of stress, hunger, fullness, and satiety cues, reduce stress mindfulness-based prenatal behavioral intervention for and increase resilience to stressors, improve eating be- health weight gain during pregnancy [44, 45]. We found haviors, and modify to a certain extent the coupling be- that the participants in our target population faced sub- tween stress and overeating. By doing this, we hoped stantial stressors in multiple domains of financial, rela- that the intervention would result in healthy gestational tionship, pregnancy-related, and weight and health- weight gain within IOM guidelines, and theoretically im- related situations. They were very interested in the idea prove maternal outcomes, neonatal outcomes, and off- of a stress-reduction intervention and were open to the spring outcomes postpartum. The area within the mindfulness approach that we described. Next we con- curved blue box illustrates the portion of the study this ducted a proof-of-concept pilot study, which informed paper focuses on: development of the intervention and recruitment methods, data-driven selection of interven- assessment of its impact on hypothesized mediators. The tion content, and intervention delivery logistics. This rectangular box indicates how our model follows the ap- was followed by the MAMAS intervention trial, which is plication of the ORBIT model. the primary focus of this paper. We first describe the In this paper we describe a) our process model for overview of the study and sample, then intervention de- intervention development; b) the content of the inter- velopment and content, and end with quantitative ana- vention resulting from this process; c) attendance, feasi- lyses of proposed mechanisms. bility and teacher fidelity to the intervention; d) the intervention’s effects on proposed mechanisms of change Participants and setting (mindfulness, acceptance, emotion regulation); and e) Participants in the San Francisco Bay Area were re- whether these were related to well-being (reductions in cruited between 8 and 20 weeks gestation and screened stress, depressed mood) and non-homeostatic eating be- for eligibility, completed clinical assessments, and began haviors (emotional eating and external eating), focusing the intervention between 12 and 20 weeks gestation. In- only on the participants who received the intervention clusion criteria were: being pregnant, age 18 to 45 years, (not including the comparison group). pre-pregnancy BMI minimum = 25 and maximum = 41 or < 300 pounds, and income to poverty ratio ≤ 500% Methods (median income to poverty ratio in the Bay Area, spe- The Maternal Adiposity, Metabolism, And Stress cific to family size). We utilized a wide array of direct (MAMAS) study was funded by a National Institutes of and indirect recruitment strategies and found that in- Health U01 collaborative research mechanism intended person recruitment at hospital-based prenatal clinics to facilitate developmental approaches to translating produced the highest yield of participants. Establishing basic research into effective behavioral interventions for close relationships with prenatal care providers, clinic chronic disease. We used the Obesity-Related Behavioral staff, social service agencies and study participants was Intervention Trials (ORBIT) model of intervention de- an essential precursor to successful recruitment and re- velopment , which outlines clear phases for a flexible tention of our study participants . Fig. 1 Theoretical Model Vieten et al. BMC Pregnancy and Childbirth (2018) 18:201 Page 4 of 14 Prospective participants engaged in a group or individ- would be suitable to the specific sources of stress, needs ual orientation session to learn more about the study re- and capacities of the target population. These data also in- quirements and informed consent was obtained from formed recruitment materials, reading levels and language those who chose to participate . A total of 110 preg- used to describe concepts, and incentives for participating. nant women were recruited to participate in 11 waves of We selected intervention components designed to the intervention with 7–13 participants in each wave be- achieve the intended outcomes (healthy gestational tween 2011 and 2013. One hundred non-randomized weight gain and reduced distress) through our theorized treatment-as-usual participants were recruited as a com- mechanisms of action (eating behavior, mindfulness of parison group: their data are not provided in this paper. food choices and hunger, fullness, and taste satiety cues; Orientations and intervention sessions were conducted at acceptance-based coping, mindfulness, and improved CPMC’s St. Luke’s Hospital and community health centers emotion regulation through reappraisal rather than sup- in the San Francisco Bay Area. The clinical assessments pression of distress). Components were selected that took place at the UCSF General Clinical Research Center demonstrated evidence for 1) reducing distress and im- where hospital emergency care was immediately available. proving mood in pregnant women and new mothers (the Mindful Motherhood Training ); 2) reducing Intervention development overeating and binge eating (Mindfulness-Based Eating Intervention development proceeded in three stages. Awareness Training (MB-EAT) ) and Supporting First, we created an initial provisional intervention. Sec- Health by Integrating Nutrition and Exercise (SHINE) ond, the intervention was refined and optimized through ). These components were modified to be appropri- an iterative process over the course of eleven waves of ate for the target population, and to more directly target participants (n = 110). Participants in each wave received the stress-overeating interaction. The overall format successive versions of the intervention. Intervention fa- from these mindfulness intervention derivatives were in- cilitators were selected based on three criteria: 1) experi- spired by Mindfulness-Based Stress Reduction (MBSR) ence facilitating mindfulness-based health interventions, . Like other mindfulness-based interventions that 2) experience working with pregnant women and new have been empirically supported, an eight-week length of mothers matching the target population, and 3) willing- intervention was determined to be suitable for delivering ness to adhere to a research protocol by a) adhering to a information in a relatively brief window that would pro- manualized intervention, b) providing facilitator feed- vide enough time for participants to introduce and incorp- back, and c) participating in intervention refinement. orate new concepts and behaviors, while allowing for Two facilitators were selected for this project, one a potential short-term changes in weight gain trajectories. Masters-level psychology student, and the other a certi- fied nurse midwife (CNM) and family nurse practitioner Intervention manual refinement (FNP), both with extensive experience working with di- Intervention sessions were audio-recorded and the inter- verse populations formally training in mindfulness-based vention facilitators met weekly with clinical supervisors interventions. Both were trained and supervised by the (CV and JK) by phone to review and discuss feasibility, primary MMT intervention developers (CV and JK). effectiveness, and areas for improvement. Changes to Third, we assessed participants’ retention, engagement the initial intervention were made through an iterative and subjective response to the intervention and exam- process based on: 1) weekly facilitator feedback; 2) ined pre- to post-intervention changes in hypothesized supervisor review and assessment of audio recordings of mediators of mindfulness, mindful eating, activity levels, sessions, and 3) mid-course and post-course participant and acceptance-based coping. evaluations. Proposed changes were made in consensus decision making sessions among the curriculum devel- First stage of intervention manual opment team and were then included in the manual for The initial intervention manual was created using a the subsequent wave. Substantial changes were made problem-formulation approach  which calls for tai- during waves 1–5, such as simplifying the movement loring interventions to match the population and prob- series and moving it to the beginning of each session, re- lem being addressed. We developed the initial content ducing time spent on and simplifying delivery of stress- and structure of the intervention based on a theory of reduction concepts, increasing focus and time spent on change, literature review, and qualitative analysis of nutritional recommendations with more concrete exam- focus group responses of 59 stressed, low-income, over- ples and the “what to eat, how to eat, and how much to weight/obese pregnant women . We then selected eat” framework, and changing exercises and metaphors components from existing mindfulness-based eating and to ones that were more relatable to the population (such stress reduction interventions that have shown promise as stress from feeling overwhelmed at work to stress for improving eating, stress, and mood [40, 48–52] and from having the car break down on the freeway). More Vieten et al. BMC Pregnancy and Childbirth (2018) 18:201 Page 5 of 14 subtle refinements were made during waves 6–11, such A strong social support component organically emerged as creating more time for question and answer periods in which women described feeling relief through sharing after specific exercises, and making exercises more inter- their experiences and hearing about the experiences of active to assure participants were engaged and following other women. the material. The process led to several key decisions about the structure and content of the training, and 1) Nutrition and Eating Behavior Recommendations. changes from the provisional version to the resulting The nutritional components included 1) “What to final intervention. Eat” - including recommendations for choosing more fresh whole foods, and less high sugar/ Final intervention processed foods, discussion of nutritional content, The resulting intervention, the Mindful Moms Training recipes and cooking instructions, drinking more (MMT), is an experiential training where pregnant par- water, replacing foods with more nutritional ticipants attend a two-hour group session once a week options, and reading or scanning labels & calories; for eight weeks and are asked to engage in assigned 2) “How Much to Eat” - discussion of portion sizes readings and experiential practice daily between sessions and proportions of vegetables, proteins, grains, (note: the terms “training” and “session” are used fruits, dairy, and fats, using the plate method and intentionally rather than “class” to imply an active rather food pyramid as tools, and 3) “How and When to than passive stance of participants). Each session begins Eat” - discussion of changing unhealthy eating with a period of mindful movement, such as gentle behaviors such as eating in front of the TV or stretching and beginner level yoga (~ 15 min), followed eating chips out of the bag, and encouraging by a verbal check-in regarding home practice and pro- healthy eating behaviors like eating more small gress toward goals in the previous week (~ 15 min), dis- meals per day rather than few large ones, and using cussion of a mindful stress reduction topic (~ 15 min), small-sized plates. mindful eating and nutritional recommendations (~ 30– 2) Mindful eating. The mindful eating portions of the 40 min), mindfulness practice (~ 15 min), review of course were adapted from the Mindfulness-Based home practice and goals for the coming week (~ 10 min) Eating Awareness Training (MB-EAT) program , and review/checkout/closing (~ 10 min). [56, 57]. MB-EAT focuses on fostering mindful Participants were asked to complete all 8 sessions to awareness while eating (i.e., paying attention rather the best of their ability, and participants who thought than distracting or “zoning out” while eating). In they might not be able to attend more than two sessions particular, participants learned and practiced in class: at the scheduled times were not enrolled. Participants 1) mindful awareness of hunger and fullness; 2) who missed a session were called the next day by the mindful awareness of taste satisfaction and satiety; teaching assistant, and the content of the session and and 3) mindful awareness of food choices. They also recommended homework was reviewed with them. Class learned to be more aware of thoughts and feelings sessions were held at 5:30 pm on a weekday for the most related to eating, including discussion of stress and part, which was determined through focus groups to be emotional eating, and learning how to use mini- the best time for most pregnant women since many of meditations before meals. A key element of this them worked during the day, or needed to wait until a component of the program were in-depth experiential partner or grandparent came home from work to care eating exercises using food in class, such as exploring for other children. Participants were welcomed to bring taste satiety through mindful eating of potato chips, food to the sessions since they occurred during most learning to rate level of hunger prior to eating a piece people’s dinner time. We provided incentives for attend- of chocolate cake, and assessing fullness while drinking ing group sessions including free gifts such as water bot- a bottle of water. As in MB-EAT, we made the tles, yoga mats, baby clothing, and other items donated distinction that mindful eating entailed cultivating by local companies. Each participant was reimbursed “inner wisdom,” while adapting nutritional recom- $25 at the end of each session for childcare and trans- mendations to personal needs was “outer wisdom,” so portation costs. We did not offer childcare due to poten- that participants could understand the distinction tial the liability involved. between the two and utilize both in their eating The training focuses equally on 1) nutritional and eat- behaviors and food choices. ing behavior recommendations, 2) mindful awareness of 3) Mindfulness for stress reduction. Content for this hunger, fullness, taste satiety, and food choices, and 3) portion was adapted from Mindfulness-Based Stress mindfulness skills for stress reduction (sitting medita- Reduction , Mindfulness-Based Cognitive tion, gentle stretching, acceptance-based stress coping Therapy , and the Mindful Motherhood concepts, and informal practices in daily living) (Table 1). Training , with inspiration from Mindfulness- Vieten et al. BMC Pregnancy and Childbirth (2018) 18:201 Page 6 of 14 Table 1 Mindful Moms Training primary intervention components Nutritional/Eating Behavior Mindful Eating Mindful Stress Reduction What to Eat Mindful vs. Mindless Eating Acceptance-Based Coping How Much to Eat Hunger and Fullness Present Moment Awareness How and When to Eat Taste Satisfaction and Satiety Awareness of Breathing Food Choices Body Scan Stress and Emotional Eating Observing Thoughts and Feelings Mini-Meditations Before Meals Mindful Connection with Baby Self-Compassion Based Childbirth and Parenting . Elements of Measures Mindful Self-Compassion training were An array of measures was administered as part of the lar- included as well, since many women reported ger MAMAS study and are reported elsewhere (Epel E, experiencing stress from their own perceived Laraia B, Coleman-Phox K, Leung C, Vieten C, Mellin L, failings. This was also designed to buffer against Kristeller J, Thomas M, Stotland N, Bush N et al: Effects of stress potentially caused by the intervention’s a mindfulness-based intervention on distress, weight gain, focus on weight and eating, which for many and glucose control in pregnant low-income women: a women can result in shame or self-criticism. The controlled trial, in preparation, ) (see Additional file 1 stress reduction components of the course were – MAMAS Study Demographics Questionnaire in delivered through interactive discussion, small supplementary materials online). Measures specific to group and dyad work, and experiential exercises the intervention development portion of the project are focused on acceptance-based coping techniques. reported here: Five types of mindfulness were taught: awareness of 1) Participant Retention/Attendance. Participants were breathing, awareness of body sensations (both sitting and asked to report how many hours they practiced while moving), awareness of thoughts and feelings, aware- homework per week, and attendance at sessions ness of connection with the baby, and mindful awareness was tracked by facilitators. in everyday life (including eating, but also extending to 2) Instructor Fidelity Assessment. All session were such activities as being mindful while showering, or while audio-recorded, and between 2 and 5 sessions from washing dishes). It also included mini-discussions on each wave were randomly selected to be assessed by topics such as “The Observing Self,”“What is Accept- trained graduate psychology students, using a ance?,”“Thoughts are not Facts,”“Focusing on the Present checklist for the extent to which facilitators Moment,”“Mindfulness in Relationships,”“Mindful Deci- delivered the primary components of the sion Making,” and “Self-Compassion.” We found it very intervention as outlined in the manual (see important to make these topic discussions highly inter- Additional file 2 – MAMAS Study Fidelity active rather than didactic, using Socratic methods, meta- Assessments in the supplementary materials phors, and frequent real-world examples. online). A total of 32 sessions were reviewed. The overall course content was summarized for partici- 3) Participant Response. A Final Evaluation pants in what we called the “Three Commitments” repre- Questionnaire was given to participants in Waves sented by the slogan “Mindful Eating, Move My Body, 1–11 at the end of the final class for each wave Breathe!” (see Fig. 2). Throughout each session, the three or was mailed to participants who did not attend commitments were reinforced. Participants were provided the last class (see Additional file 3 – MAMAS with laminated cards summarizing the primary program Study Final Evaluation in supplementary components (see Fig. 1). At the beginning of each session, materials online). the group discussed progress and obstacles from the pre- Fifty-eight questionnaires were returned, of 110 vious week and troubleshooting, problem solving, and total participants. The questionnaire included goal setting for the coming week. At the end of each ses- structured and open-ended questions about the sion, homework for the coming week was reviewed (e.g., program including convenience of class location reading assignments, mindful eating, nutrition and exer- and time, reasons for enrolling, teacher attention, cise recommendations, and recorded guidance for mindful satisfaction with the program, likes and dislikes, awareness practice). A brief practice of compassion/self- usefulness and frequency of use of program com- compassion meditation closed each session. ponents (Mindful Awareness of Breathing, Vieten et al. BMC Pregnancy and Childbirth (2018) 18:201 Page 7 of 14 Fig. 2 Mindful Moms Three Daily Commitments Mindful Movement, Mindful Eating), comprehen- to increase psychological flexibility/acceptance and de- sion of mindfulness and acceptance, use of mind- crease experiential avoidance. fulness skills outside of program, and amount of The Emotion Regulation Questionnaire (ERQ) is a time outside of program spent using new skills 10-item questionnaire that assesses positive reappraisal each week. (the ability to reframe or look at situations in a positive 4) Self-Report Questionnaires. Participants were asked light) (α = .79), and emotional suppression (the tendency to to complete baseline measures upon enrollment and suppress and avoid negative emotional responses) (α =.73). post-intervention measures nine weeks later, The Perceived Stress Scale (PSS)  was used to meas- including: ure the degree to which situations in one’s life are ap- The Five Facet Mindfulness Questionnaire (FFMQ) praised as stressful, or how unpredictable, uncontrollable,  assesses the general tendency to be mindful in and overloaded respondents find their lives (α =.91). The daily life with subscales to assess respondents’ ability Patient Health Questionnaire (PHQ-9)  was used to to act with awareness (α =.86), observe experiences measure depressive symptoms (α =.86–.89) . (α = .78), describe feelings (α = .91), non-judging To assess eating behavior outcomes, we utilized two (α =.86), and non-reactivity (α =.73) . The scales of the Dutch Eating Behavior Questionnaire : FFMQ has been shown to have convergent and dis- emotional eating (α = .93), or overeating in response to criminant validity in relation to other psychological emotions, and external eating (α = .80), or eating in re- constructs in meditating and non-meditating sam- sponse to food-related stimuli, regardless of the internal ples. The intervention was designed to increase mind- states of hunger and satiety. fulness generally, and thus all subscales were included. Statistical analyses We compiled descriptive results (means, standard devi- To assess the potential mechanism of mindful eating, ations, or frequencies) for teacher fidelity to the critical we utilized two scales from the Mindful Eating Question- domains of the intervention, class attendance and ad- naire (MEQ) : mindful awareness of eating, such as herence. To assess change in presumed mechanisms, noticing flavors, sweetness, colors, and smells of food) we used paired t-tests comparing baseline and endpoint (α = .74), and eating in response to external cues (e.g. scores. Pearson correlation coefficients were calculated eating because the food is there, such as eating popcorn to evaluate changes in general mindfulness, acceptance, in a movie theater or candy from a dish) instead of in re- mindful eating correlated with perceived stress score sponse to hunger, (α = .70). changes. All analyses were conducted using SAS soft- The Acceptance and Action Questionnaire (AAQ)  ware . is a ten-item questionnaire that measures psychological flexibility, or the ability tolerate negative thoughts and Results feelings (acceptance) in the pursuit of goals or, depend- Demographics ing upon the situation, change behavior to accomplish As shown in Table 2, participants in the intervention goals (action) (α = .84). The intervention was designed were an average of 28 years old, predominantly low Vieten et al. BMC Pregnancy and Childbirth (2018) 18:201 Page 8 of 14 Table 2 Demographics Table 3 Participant percentage of total sessions attended by wave MMT (n = 110) Wave % of total sessions attended SD N Age (years), mean (SD) 27.8 (5.7) W1 0.83 0.29 8 N (%) W2 0.71 0.26 12 Race/ethnicity W3 0.84 0.23 12 White 14 (12.8) W4 0.84 0.32 7 African American 39 (35.8) W5 0.69 0.28 10 Latino 35 (32.1) W6 0.78 0.23 8 Other/ Multiracial 21 (19.2) W7 0.83 0.15 9 Education W8 0.88 0.19 6 < 12 years 10 (9.1) W9 0.75 0.26 13 High school graduate/GED 30 (27.3) W10 0.84 0.28 9 Any college or vocational training 56 (50.9) W11 0.75 0.36 12 College graduate or higher 14 (12.7) Total 0.79 0.06 106 Marital status Married or in committed relationship 74 (67.3) Single, separated or divorced 36 (32.7) moved, 1 unable to attend classes, and 5 unable to con- Household income, mean (SD) $24,723 ($22,459) tact). Participants attended a mean of 5.73 (SD 2.31) ses- Number of previous children, mean (SD) 0.8 (1.0) sions out of 8 with a median of 7 (see Table 3 for Pre-pregnancy weight status number of participants and percent of total sessions attended by wave). Overall, the mean number of classes Normal or overweight 58 (55.2) attended was 0.79 (SD .06) On average, women reported Class I obese 30 (28.6) spending 4.1 h (range 0.16–17.5) outside of class prac- Class II obese 17 (16.2) ticing the new skills they learned each week. Food-Insecure 44 (41.9) Smoking status Facilitator Fidelity Current smoker 5 (4.8) Intervention fidelity was good. In 93% of the sessions Former smoker 44 (42.3) reviewed, the intervention facilitators “mostly” or “com- Never smoker 55 (52.9) pletely” implemented the “Move My Body” gentle stretching aspect of the intervention. In 88% of the ses- Leisure-time physical activity sions the facilitators “mostly” or “completely” provided Inactive or light activity 58 (56.9) the “Mindful Eating” portion of the intervention. In 69.2% Moderate or vigorously around 3 times/week 21 (20.6) of the sessions facilitators “mostly” or “completely” deliv- Moderate or vigorously on most days 23 (22.6) ered the “Breathe” mindfulness-stress reduction compo- nent. Facilitators “completely” reviewed the three commitments at the end of each session 88.5% of the time, income, women of color, 78.2% had a high school dip- and 73% of sessions ended in the compassion meditation loma and/or some college or vocational training, and as indicated in the manual. 13% had a college degree. Thirty-three percent were sin- gle, separated, or divorced. There was a notable amount Participant response of food insecurity (42%) . Around 45% were obese, Fifty-eight women (53%) completed a Final Evaluation and 55% were overweight. Women started the interven- Questionnaire. The lower response was due to the ques- tion at a mean of 15.9 (SD = 3.8) weeks gestation and tionnaire being sent after the completion of the post- completed it at a mean of 24 (SD = 3.0) weeks gestation. intervention research assessment. We strongly recom- mend in future studies that program evaluation ques- Participant retention/attendance tionnaires be completed in class or at assessment visits Of the 114 women enrolled in the intervention, eight to improve response rates. Among those who responded, women did not complete the baseline questionnaires most reported that the class location was either “very and thus their quantitative data are not reported here. convenient” (60%) or “somewhat convenient” (29%), as Four women miscarried and 7 were lost to follow up (1 was the day and time of the class (“very convenient” Vieten et al. BMC Pregnancy and Childbirth (2018) 18:201 Page 9 of 14 55%; “somewhat convenient” 41%). Almost all partici- Correlations between changes in targets and outcomes pants felt they had enough opportunities to ask any As shown in Table 6, as hypothesized, there was a pat- questions they had of the teachers during or after class tern showing that increases in measures of mindfulness (95%; 3% did not have any questions to ask). Most par- were associated with decreases in distress (stress and de- ticipants were “very satisfied” 71% or “satisfied” 29% pression) and self-reported eating behavior. Specifically, overall. No one endorsed being “dissatisfied” or “very increases in psychological flexibility (acceptance) were dissatisfied”. All participants reported understanding of significantly correlated with decreases in stress, depres- the idea of acceptance (“understood it very well” 65%; sion and emotional eating (but not external eating). “understood it somewhat” 35%). Similarly, improvements in all five of the mindfulness Participants reported finding the three major program (FFMQ) subscales were correlated with decreases in ei- components useful, and most participants practiced at ther stress or depression or both. Increases in the mind- least one mindfulness skill at least a few times over the fulness subscales measuring “acting with awareness” and past week (Table 4). The eating and movement advice “non-judging” were correlated with a decrease in emo- for outside of class (the three basic commitments and tional eating and external eating. Finally, increases in the tips for eating healthy and movement) was also found to reappraisal form of emotion regulation were correlated be useful (“very useful” 46%; “useful” 49%; “not very use- with decreased stress and emotional eating, whereas in- ful” 4%; and “not at all useful” 2%). Ninety-five percent creases in emotion suppression were correlated with in- of the participants used one or more of the skills or con- creased stress, depression, and a non-significant increase cepts learned in the program outside of class. Mindful in emotional eating. There were no associations between breathing was most endorsed (48%), followed by mindful the mindful eating subscales of “awareness” and “exter- eating (36%), and mindful movement (33%). nal eating” with stress, depression, or eating behaviors. Changes in aspects of mindfulness and emotion regulation Discussion We assessed changes in mindfulness in several domains In this study, we developed and tested an eight-week (mindful eating, psychological flexibility/acceptance, the five mindfulness-based intervention directed toward redu- facets of mindfulness captured by the FFMQ, and emotion cing stress and overeating in pregnancy. We have de- regulation), from pre-intervention to post-intervention, scribed both the content of the intervention, and the within subjects. There were significant increases in mindful iterative process of intervention development required eating (awareness of eating, p < .01), and non-significant re- to adequately tailor and optimize the intervention for a ductions in external eating (p = .09). There were improve- high-risk sample. We utilized the ORBIT model, which ments in three of the five mindfulness subscales of the recognizes that interventions must be customized to FFMQ: observe (p < .0001), non-judging (p =.03), and non- meet the needs of special vulnerable populations, and reactivity (p = .002) with a non-significant trend toward im- intervention development must be strongly informed by provement in the “act with awareness” subscale (p = .08). iterative feasibility testing with the target population. There were also increases in AAQ psychological flexibility/ The resulting Mindful Moms Training (MMT) is a acceptance (which can also be described as reductions in mindfulness-based psychosocial intervention for low- to experiential avoidance) (p < .0001), and in adaptive emotion middle-income overweight/obese pregnant women that regulation in the tendency toward reappraisal (p = .002), was designed to foster healthy weight gain during preg- with no change in tendency for emotional suppression (see nancy and reduction of transmission of obesity to infants Table 5). There were significant improvements in PSS per- by targeting 1) reductions in stress and negative mood, ceived stress (p < .0001) and PHQ depression (p < .0001) through acceptance-based coping, and 2) improved nu- from pre-intervention to post-intervention. trition and healthy eating behavior during pregnancy Table 4 Participant reported usefulness and frequency of use of intervention components (n = 58) How useful? How often used over past week? Program Components Not at all Not very Useful Very useful Did not A few times 1×/day Several times useful useful use most days most days Mindful Awareness of 0% 3% 41% 55% 2% 31% 40% 27% Breathing Mindful Movement 0% 7% 44% 53% 7% 32% 30% 32% Mindful Eating 0% 7% 40% 53% 11% 39% 30% 20% Three Basic Commitments 2% 4% 49% 46% N/A N/A N/A N/A Vieten et al. BMC Pregnancy and Childbirth (2018) 18:201 Page 10 of 14 Table 5 Changes in mindfulness and emotion regulation from pre- to post- intervention Pre Post Change in Intervention Group Mean (SD) Mean (SD) P Mindful Eating – Awareness (MEQ) N = 79 2.55 (0.6) 2.73 (0.7) 0.01 Mindful Eating – External (MEQ) N = 77 2.31 (0.6) 2.43 (0.8) 0.09 Psychological Flexibility (AAQ) N = 80 49.92 (10.1) 53.67 (8.9) < 0.0001 Mindfulness – Observe (FFMQ) N = 81 25.64 (6.2) 28.61 (6.1) < 0.0001 Mindfulness - Describe (FFMQ) N = 81 29.05 (5.6) 29.67 (5.2) 0.19 Mindfulness - Act w/Awareness (FFMQ) N = 80 28.40 (6.0) 29.28 (5.0) 0.08 Mindfulness - Nonjudge (FFMQ) N = 80 27.48 (5.9) 28.76 (5.6) 0.03 Mindfulness - Nonreact (FFMQ) N = 80 19.60 (4.7) 21.27 (4.0) 0.002 Emotion Regulation - Reappraisal (ERQ) N = 78 28.29 (6.5) 30.46 (6.5) 0.002 Emotion Regulation - Suppression (ERQ) N = 80 12.51 (5.0) 12.88 (4.8) 0.51 Perceived Stress (PSS) N = 82 18.62 (6.1) 15.77 (5.7) < 0.0001 Depression (PHQ9) N = 82 7.12 (5.6) 4.57 (3.8) < 0.0001 Paired t-tests through mindful eating practices, stress reduction, and mindfulness - the ability to observe inner experiences increased activity. (e.g., distressing thoughts, sensations, or emotions), non- We were able to obtain excellent retention, attend- judgment, and non-reactivity to those experiences. In ance, and reporting of home practice outside of the class addition, we found increases in psychological flexibility, setting. Attendance was similar across waves. Partici- which is defined by greater acceptance of experiences (i.e., pants reported high satisfaction with the program, in reductions in experiential avoidance), as well as the ability terms of content and logistics. We also found strong fa- to regulate emotions by reappraising situations. Further, cilitator fidelity to the intervention. we found evidence that improvements in mindfulness Partial support was found for the hypothesized me- were correlated with decreases in stress, depression, and chanisms of change: general mindfulness, mindful eating, emotional and external eating (i.e., eating to soothe dis- acceptance, and emotion regulation. We found impro- tress or in response to environmental cues instead of hun- vement in awareness of eating, and three facets of ger or caloric need). Table 6 Pearson correlations between change in mindfulness measures and changes in distress and eating behavior Changes in Mindfulness Variables n Change in Change in Change in Change in Perceived Depression Emotional External eating Stress (PSS) (PHQ-9) Eating (DEBQ) (DEBQ) Mindful Eating Questionnaire Mindful Eating - Awareness (MEQ) 58–79 −0.10 −0.02 −0.18 −0.02 Mindful Eating - External (MEQ) 56–77 −0.00 −0.08 −0.06 0.04 Acceptance and Action Questionnaire Psychological Flexibility (AAQ) 59–80 − 0.26* − 0.40*** − 0.22* − 0.02 Five Factor Mindfulness Questionnaire Mindfulness - Observe (FFMQ) 59–81 − 0.33** − 0.06 − 0.17 0.00 Mindfulness - Describe (FFMQ) 59–81 − 0.36*** − 0.42*** − 0.13 − 0.12 Mindfulness - Act With Awareness (FFMQ) 59–80 − 0.18 − 0.46*** −0.25* − 0.32** Mindfulness - Nonjudge (FFMQ) 59–80 −0.14 − 0.26* −0.28* − 0.33** Mindfulness - NonReact (FFMQ) 58–80 −0.36** − 0.13 −0.16 − 0.05 Emotion Regulation Questionnaire Emotion Regulation - Reappraisal (ERQ) 58–78 −0.28* −0.03 − 0.25* −0.19+ Emotion Regulation - Suppression (ERQ) 59–80 0.22* 0.26* 0.18 0.13 *** = p < .001, ** = p < .01, * = p < .05, + = p < .10 The sample size (n) varies, ranging from 56 to 80, as shown, due to missing data Vieten et al. BMC Pregnancy and Childbirth (2018) 18:201 Page 11 of 14 These results support the presumed mechanisms of and weight gain. It is difficult to recruit subjects and im- mindfulness practices in reducing distress and improving plement a group intervention during the first trimester eating behavior in pregnant women. The primary out- since many women do not realize that they are pregnant, comes from the nonrandomized trial that utilized this or trust in the viability of the pregnancy, until the end of intervention (reported elsewhere (Epel E, Laraia B, Cole- the first trimester. Future studies could focus on pre- man-Phox K, Leung C, Vieten C, Mellin L, Kristeller J, pregnancy women, or provide a drop-in style group for- Thomas M, Stotland N, Bush N et al: Effects of a mindful- mat immediately upon confirmation of pregnancy. ness-based intervention on distress, weight gain, and glu- While the brief and nonpharmacological nature of this cose control in pregnant low-income women: a controlled intervention makes it a promising candidate for wide- trial, in preparation)) showed that women who were spread use in supporting well-being in pregnancy, a lon- enrolled in MMT, compared to a non-randomized com- ger, more intensive intervention may be more effective in parison group of women receiving treatment as usual, had limiting excessive weight gain. When a sample has high significant reductions in perceived stress, depressive food insecurity, as this sample did, providing healthy food symptoms, and glucose levels after an oral glucose toler- directly or easier access to healthy food may improve effi- ance test (glucose regulation), but no differences in cacy. We are pilot testing further curriculum development whether they met Institute of Medicine (IOM) criteria for to augment MMT by providing both cooking skills (hands recommended weight gain. Although there were no de- on kitchen training) and fresh grocery bags each week, tectable effects on the primary outcome of weight, the and preliminary feedback from participants has been fa- positive effects on mothers’ mental health are important. vorable. In their evaluations, participants suggested that Those in MMT had lower depression, not just post- the MMT program could also expand mindfulness medi- intervention but throughout the postpartum period . tation and sharing time, and meet every other week until Additionally, their offspring had fewer medical visits . later in the pregnancy. We are currently following this sample to examine devel- Recruitment and retention were difficult, requiring tre- opmental effects on offspring. mendous staff effort and devotion of study resources, Our results should be interpreted while bearing in mind which has implications for scaling to a community setting. the study’s limitations. We had a substantial rate of miss- The narrow window of eligibility for enrolling women in a ing final participant evaluations of the intervention that group intervention during the 2nd trimester of pregnancy may have led to biased results, and could not compare presents unique obstacles. Logistical issues particularly those who completed the final evaluations with those who common in low-income samples, such as inflexible work did not because we collected them anonymously (to help schedules, lack of transportation/reliance on public tran- participants feel completely free to be critical in light of sit, and need for childcare also created barriers. In order the power differential). Also, because the intervention was to optimize recruitment and retention efficiency for future developed through an iterative process over the course of interventions, it may be useful to more fully integrate the the study, each wave of participants provided data based program with existing support programs or organizations/ on slightly different intervention designs. While statisti- communities for low-income pregnant mothers. cally significant, changes in mindful eating (awareness) and mindfulness (observe, nonjudge, and nonreact) sub- scales were small (< 12%). Since there are not yet norms Conclusions established for clinically meaningful improvements, it is Pregnancy is a critical period for both maternal and off- possible that these improvements are clinically negligible. spring health, and there is need to reduce distress and un- It is also possible that even minor improvements in these healthy eating during pregnancy, particularly for women at variables can make a difference in the outcomes of inter- greatest risk for high stress and excessive gestational weight est. Reductions in perceived stress and depression were 15 gain. Through an iterative process of intervention develop- and 36% respectively, which are more noticeable clinically. ment, wehavedeveloped amindfulness-based programde- Reported relationships between increased mindfulness/ac- signed to reduce stress and encourage healthy weight gain ceptance and reduced stress, depression, emotional eating that we have demonstrated is feasible to utilize with a high- and external eating were based on correlations, and thus, stress diverse pregnant population. Partial support was we cannot infer causal relationships. Power was not ad- found for effects of the intervention on hypothesized mech- equate to conduct a more thorough analysis of the rela- anisms of change: general mindfulness, mindful eating, ac- tionships between these change scores while controlling ceptance, and emotion regulation. Improvements in for potentially confounding variables. mindfulness were correlated with decreases in stress, de- Another limitation of this project was that pregnant pression, and self-reported emotional and external eating. women began the intervention in the second trimester, By sharing our process of intervention development which is potentially late for addressing eating behaviors and initial findings regarding the mechanisms of MMT Vieten et al. BMC Pregnancy and Childbirth (2018) 18:201 Page 12 of 14 effects, we hope to make future studies in this area eas- California Pacific Medical Center (CPMC) (FWA00000921), the University of California, Berkeley (FWA00006252), and Contra Costa Regional Medical ier to implement. Our intervention manual is available Center and Health Centers (FWA00008831) review boards. Written consent upon request to be tailored for other populations. These was obtained from each participant. findings should encourage practitioners and policy- Competing interests makers that even in very high risk samples, pregnancy is The authors declare that they have no competing interests. a window of opportunity for behavior change that can improve metabolic and mood trajectories both for Publisher’sNote women and their offspring. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Author details Additional files California Pacific Medical Center Research Institute, 475 Brannan Street, San Francisco, CA 94120, USA. Institute of Noetic Sciences, 625 Second Street, Additional file 1: MAMAS Study Demographic Questionnaire. (PDF 568 kb) 3 # 200, Petaluma, CA 94952, USA. Center for Health and Community, Additional file 2: MAMAS Study Facilitator Fidelity Assessment. (PDF 292 kb) University of California, San Francisco, 3333 California St., Suite 465, Box 0844, San Francisco, CA 94143-0844, USA. School of Public Health, Additional file 3: MAMAS Study Final Evaluation Questionnaire. (PDF 71 kb) University of California, Berkeley, 207-B University Hall, Berkeley, CA 94720-7360, USA. Department of Psychology, Indiana State University, Terre Haute, Indiana Abbreviations 47809, USA. Department of Pediatrics, University of California, San Francisco, AAQ: Acceptance and action questionnaire; BMI: Body mass index; 550 16th Street, San Francisco, CA 94158, USA. School of Human Ecology, CNM: Certified Nurse Midwife; CPMC: California Pacific Medical Center; University of Wisconsin-Madison, 1300 Linden Drive, Madison, WI 53706, USA. CRC: Clinical Research Center; DEBQ: Dutch eating behavior questionnaire; ERQ: Emotion Regulation Questionnaire; FFMQ: Five factor mindfulness Received: 24 May 2017 Accepted: 20 April 2018 questionnaire; FNP: Family Nurse Practitioner; IOM: Institute of Medicine; MAMAS: Maternal adiposity, metabolism, and stress; MBCT: Mindfulness- based cognitive therapy; MB-EAT: Mindfulness-Based Eating Awareness References Training; MBSR: Mindfulness-based stress reduction; MEQ: Mindful eating 1. Ogden CL, Carroll MD, Lawman HG, Fryar CD, Kruszon-Moran D, Kit BK, questionnaire; MMT: Mindful moms training; ORBIT: Obesity-Related Flegal KM. Trends in obesity prevalence among children and adolescents in Behavioral Intervention Trials; PANAS: Positive and negative affective scale; the United States, 1988-1994 through 2013-2014. JAMA. 2016;315(21):2292–9. PSS: Perceived stress scale; SHINE: Supporting Health by Integrating Nutrition 2. Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in and Exercise; UCSF: University of California, San Francisco obesity among adults in the United States, 2005 to 2014. JAMA. 2016; 315(21):2284–91. Acknowledgments 3. Institute of Medicine. Weight gain during pregnancy: reexamining the We thank Holly Wing, Gwen Valencia-Moscoso, Nina Fry, Ingrid Ammondson, guidelines. Washington DC: National Academies Press; 2009. Amber Benson, Samantha Schilf, Vanessa Tearnan, for their assistance with 4. Catalano P, Ehrenberg H. The short-and long-term implications of maternal participant recruitment and data collection; Cy de Groat, Michael Coccia, and obesity on the mother and her offspring. BJOG. 2006;113(10):1126–33. Alan Pierce for assistance with data management and statistical analysis; the 5. Hedderson MM, Weiss NS, Sacks DA, Pettitt DJ, Selby JV, Quesenberry CP, California Pacific Medical Center (CPMC) Research Institute Clinical Research Ferrara A. Pregnancy weight gain and risk of neonatal complications: Team, the University of California, San Francisco (UCSF) Clinical Research macrosomia, hypoglycemia, and hyperbilirubinemia. Obstet Gynecol. 2006; Center (CRC); and the CPMC, San Francisco General Hospital, UCSF, and 108(5):1153–61. community women’s health facilities. We also thank Hokhmah Joyallen, 6. Li C, Liu Y, Zhang W. Joint and independent associations of gestational Shahara Godfrey, Karen Sharifa Krongold for leading the mindfulness groups; weight gain and pre-pregnancy body mass index with outcomes of and our study participants. pregnancy in Chinese women: a retrospective cohort study. PLoS One. 2015;10(8):e0136850. Funding 7. Oken E, Rifas-Shiman SL, Field AE, Frazier AL, Gillman MW. Maternal Support for this work was provided by The National Institutes of Health gestational weight gain and offspring weight in adolescence. Obstet (NHLBI U01 HL097973–02; NCCIH K01 AT005270); the Aetna Foundation, the Gynecol. 2008;112(5):999. Bella Vista Foundation, the Mental Insight Foundation, and the Lisa and John 8. Kiel DW, Dodson EA, Artal R, Boehmer TK, Leet TL. Gestational weight gain Pritzker Foundation. Funding agencies had no role in the design of the and pregnancy outcomes in obese women: how much is enough? Obstet study and collection, analysis, and interpretation of data and in writing the Gynecol. 2007;110(4):752–8. manuscript. 9. Bray GA, Champagne CM. Beyond energy balance: there is more to obesity than kilocalories. J Am Diet Assoc. 2005;105(5 Suppl 1):S17–23. Availability of data and materials 10. Adam TC, Epel ES. Stress, eating and the reward system. Physiol Behav. The datasets used and/or analyzed during the current study are available 2007;91(4):449–58. from the corresponding author upon reasonable request. 11. Garg N, Wansink B, Inman JJ. 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BMC Pregnancy and Childbirth – Springer Journals
Published: Jun 1, 2018
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