Impact of a Health Coach-Led, Text-Based Digital Behavior Change Intervention on Weight Loss and Psychological Well-Being in Patients Receiving a Procedureless Intragastric Balloon Program: Prospective Single-Arm Study.

BACKGROUND: Digital health interventions show promise for weight management. However, few text-based behavior change interventions have been designed to support patients receiving intragastric balloons, and none have simultaneously evaluated weight loss, psychological well-being, and behavior change despite the crucial interplay of these factors in weight management. OBJECTIVE: This study aims to assess whether a health coach-led, asynchronous, text-based digital behavior change coaching intervention (DBCCI) delivered to participants receiving an intragastric balloon and its aftercare program was feasible and acceptable to participants and supported improved outcomes, including weight loss, psychological well-being, and lifestyle behavior change conducive to weight loss maintenance. METHODS: This 12-month, single-arm prospective study enrolled adults aged 21 to 65 years with BMI ≥27 kg/m2 receiving a procedureless intragastric balloon (PIGB) at 5 bariatric clinics in the United Kingdom and the Netherlands. Participants received the DBCCI and the clinic-led PIGB aftercare program (remotely delivered) for 6 months after PIGB placement and then no intervention for an additional 6 months. The DBCCI was an evidence-based, personalized intervention wherein health coaches supported participants via exchanged asynchronous in-app text-based messages. Over the 12-month study, we assessed percentage of total body weight loss and psychological well-being via self-administered validated questionnaires (Warwick-Edinburgh Mental Wellbeing Scale, Generalized Anxiety Disorder Scale, Impact of Weight on Quality of Life-Lite-Clinical Trials Version, Loss of Control Over Eating Scale-Brief, Weight Efficacy Lifestyle Questionnaire-Short Form, and Barriers to Being Active Quiz). Participant engagement with and acceptability of the intervention were assessed via self-reported surveys. RESULTS: Overall, 107 participants (n=96, 89.7% female; mean baseline BMI 35.4, SD 5.4 kg/m2) were included in the analysis. Mean total body weight loss was 13.5% (SEM 2.3%) at the end of the DBCCI and 11.22% (SEM 2.3%) at the 12-month follow-up (P<.001). Improvements were observed for all psychological well-being measures throughout the 12 months except for the Generalized Anxiety Disorder Scale (improvement at month 1) and Barriers to Being Active Quiz (improvements at months 3 and 6). Surveys showed high levels of engagement with and acceptability of the DBCCI. CONCLUSIONS: This study provides evidence that the health coach-led, asynchronous, text-based DBCCI was engaging and acceptable to participants with overweight and obesity. The DBCCI, delivered alongside the PIGB and its aftercare program, supported improved weight loss outcomes and psychological well-being versus baseline and was associated with lifestyle behavior changes known to help achieve and maintain long-term weight loss and improved health outcomes. Follow-up findings suggest a potential need for longer-term, more intense coaching to focus on weight loss maintenance and support ongoing self-coaching. This could be achieved by leveraging generative artificial intelligence to provide ongoing automated behavior change coaching support to augment human-led care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05884606; https://clinicaltrials.gov/study/NCT05884606.

Application and effectiveness of eHealth strategies for metabolic and bariatric surgery patients: A systematic review.

OBJECTIVE: To date the application of eHealth strategies among adults and adolescents undergoing metabolic and bariatric surgery (MBS) has not been systematically reviewed. This study comprehensively examines eHealth intervention studies among MBS patients within the RE-AIM framework to assess reach, effectiveness, adoption, implementation and maintenance of these efforts. METHODS: A search was conducted using PubMed, EMBASE, CINAHL, PsycNET and SCOPUS of original research relating to eHealth strategies for MBS patients published in peer-reviewed journals and revealed 38 published articles between 2011 and 2019. RESULTS: Studies varied widely in terms of design (qualitative to randomized controlled trials) and eHealth delivery method (telemedicine to blog post content) with a balance of pre- or post-MBS use. No studies included adolescents and very few reported (1) a conceptual framework to support study design/outcomes; and (2) race/ethnicity composition. CONCLUSIONS: Although some studies report that eHealth strategies/interventions are effective in producing post-MBS weight loss and other positive health outcomes, most are pilot studies or have study design limitations. There is an opportunity for development of (1) tailored eHealth interventions to support pre- and post-MBS sustained behavior change and improved outcomes; and (2) rigorous studies that employ robust conceptual frameworks so dissemination and implementation efforts can be mapped to construct-driven outcomes.

Partnering Support Interventions with Bariatric Surgery to Maximize Health Outcomes in Adolescents with Severe Obesity.

OBJECTIVE: Rates of adolescents with severe obesity continue to rise worldwide, with concurrent increases in metabolic and bariatric surgery (MBS) uptake. The gap between support (lifestyle, pharmacotherapy) interventions and MBS as treatment options for adolescents has been understudied. This review, couched in a socio-ecological framework, investigates how support interventions for adolescents with severe obesity could be combined or sequenced with MBS to optimize health outcomes. METHODS: A comprehensive search revealed 36 published articles between 1995 and 2019 that included the combination of support interventions and MBS among adolescents. RESULTS: There were no studies that specifically reported outcomes or effect sizes for the combination of lifestyle intervention with MBS. Previous studies have reported individual results for either lifestyle intervention or MBS but not for their compound effect. CONCLUSIONS: As rates of adolescents with severe obesity are on the rise globally, future research should focus on how partnering support interventions with MBS can amplify positive short- and long-term health outcomes and within a socio-ecological framework. Understanding the sequence of these approaches will be of particular importance. High-risk and vulnerable populations such as ethnic minorities who have suffered a disproportionate burden of the obesity epidemic must be included in rigorously tested future trials of combination interventions to maximize health outcomes worldwide.

Behavior Modification of Diet and Parent Feeding Practices in a Community- Vs Primary Care-Centered Intervention for Childhood Obesity.

OBJECTIVE: To evaluate behavior modification of diet and parent feeding practices in childhood obesity interventions. DESIGN: Secondary analysis of randomized, controlled trial comparing Mind, Exercise, Nutrition … Do It! (MEND2-5 and MEND/Coordinated Approach to Child Health [CATCH6-12]) vs Next Steps at baseline and 3 and 12 months. SETTING: Austin and Houston, TX. PARTICIPANTS: A total of 549 Hispanic and black children randomized to programs by age groups (2-5, 6-8, and 9-12 years) INTERVENTIONS: Twelve-month MEND2-5 and MEND/CATCH6-12 vs Next Steps. MAIN OUTCOME MEASURE(S): Diet (MEND-friendly/unfriendly food groups and Healthy Eating Index-2010) and parent feeding practices (parental overt control, discipline, limit setting, monitoring, reinforcement, modeling, and covert control; and food neophobia). ANALYSIS: Mixed-effects linear regression. RESULTS: Changes in diet quality, consumption of MEND-unfriendly foods, and parent feeding practices did not differ between programs. In both interventions, MEND-unfriendly vegetables, grains, dairy and protein, added fat and desserts/sugar-sweetened beverages declined in 2-5- and 6-8-year-olds (P < .001). Healthy Eating Index-2010 improved in 2-5- (treatment; P = .002) and 6-8-year-olds (P = .001). Parental overt control decreased and limit setting, discipline, monitoring, reinforcement, and covert control increased with both interventions in 2-5- and 6-8-year-olds (P < 0.01-0.001). CONCLUSIONS: Diet quality, consumption of MEND-unfriendly foods, and parent feeding practices were altered constructively in 2 pediatric obesity interventions, especially in 2-5- and 6-8-year-olds.

The Intersection of Behavioral Science and Digital Health: The Case for Academic-Industry Partnerships.

A decade after the first health app became available, the field of digital health has produced a range of health behavior insights and an expanding product portfolio. Despite sustained interest and growth fueled by academic and industry interests, the impact of digital health on health behavior change and related outcomes has been limited. This underperformance relative to expectations may be partially attributed to a gap between industry and academia in which both seek to develop technology-driven solutions but fail to converge around respective, unique strengths. An opportunity exists for new and improved collaborative models of research, innovation, and care delivery that disrupt the field of behavioral medicine and benefit academic and industry interests. For those partnerships to thrive, recognizing key differences between academic and industry roles may help smooth the path. Here we speak specifically to concerns particular to academics and offer suggestions for how to navigate related challenges.

Addressing childhood obesity in low-income, ethnically diverse families: outcomes and peer effects of MEND 7-13 when delivered at scale in US communities.

OBJECTIVES: Implementation of a large-scale, child weight management program in low-income, ethnically diverse communities provided an important opportunity to evaluate its effectiveness under service level conditions (i.e. provision as a primary care child weight management service). METHODS: MEND 7-13 is a community-based, multi-component, childhood obesity intervention designed to improve dietary, physical activity and sedentary behaviors. It comprises twice weekly sessions for 10 consecutive weeks (35 contact hours) and is delivered to groups of children and accompanying parents/caregivers. The evaluation used an uncontrolled, repeated measures design. Overall, 3782 children with overweight or obesity attended 415 MEND 7-13 programs in eight US states, of whom 2482 children (65.6%) had complete data for change in zBMI. The intervention targeted low-income, ethnically diverse families. Changes in anthropometric, cardiovascular fitness and psychological outcomes were evaluated. A longitudinal multivariate imputation model was used to impute missing data. Peer effects analysis was conducted using the instrumental variables approach and group fixed effects. RESULTS: Mean changes in BMI and zBMI at 10 weeks were -0.49 kg/m2 (95% CI: -0.67, -0.31) and -0.06 (95% CI: -0.08, -0.05), respectively. Benefits were observed for cardiovascular fitness and psychological outcomes. Mean peer reduction in zBMI was associated with a reduction in participant zBMI in the instrumental variables model (B = 0.78, P = 0.04, 95% CI: 0.03, 1.53). Mean program attendance and retention were 73.9% and 88.5%, respectively. CONCLUSION: Implementing MEND 7-13 under service level conditions was associated with short-term improvements in anthropometric, fitness and psychological indices in a large sample of low-income, ethnically diverse children with overweight and obesity. A peer effect was quantified showing that benefits for an individual child were enhanced, if peers in the same group also performed well. To our knowledge, this is the first US study to evaluate outcomes of an up-scaled community-based, child weight management program and to show positive peer effects associated with participation in the intervention.

Efficacy of a Community- Versus Primary Care-Centered Program for Childhood Obesity: TX CORD RCT.

OBJECTIVE: This randomized controlled trial was conducted to determine comparative efficacy of a 12-month community-centered weight management program (MEND2-5 for ages 2-5 or MEND/CATCH6-12 for ages 6-12) against a primary care-centered program (Next Steps) in low-income children. METHODS: Five hundred forty-nine Hispanic and black children (BMI ≥ 85th percentile), stratified by age groups (2-5, 6-8, and 9-12 years), were randomly assigned to MEND2-5 (27 contact hours)/MEND/CATCH6-12 (121.5 contact hours) or Next Steps (8 contact hours). Primary (BMI value at the 95th percentile [%BMIp95 ]) and secondary outcomes were measured at baseline, 3 months (Intensive Phase), and 12 months (Transition Phase). RESULTS: For age group 6-8, MEND/CATCH6-12 resulted in greater improvement in %BMIp95 than Next Steps during the Intensive Phase. Effect size (95% CI) was -1.94 (-3.88, -0.01) percentage points (P = 0.05). For age group 9-12, effect size was -1.38 (-2.87, 0.16) percentage points for %BMIp95 (P = 0.07). MEND2-5 did not differentially affect %BMIp95 . Attendance averaged 52% and 22% during the Intensive and Transition Phases. Intervention compliance was inversely correlated to change in %BMIp95 during the Intensive Phase (P < 0.05). In the Transition Phase, %BMIp95 was maintained or rebounded in both programs (P < 0.05). CONCLUSIONS: MEND/CATCH6-12 was more efficacious for BMI reduction at 3 months but not 12 months compared to Next Steps in underserved children. Intervention compliance influenced outcomes, emphasizing the need for research in sustaining family engagement in low-income populations.

Long-Term Outcomes following the MEND 7-13 Child Weight Management Program.

BACKGROUND: In the current study, we report outcomes 2.4 years from baseline in a random subsample of overweight and obese children who attended MEND 7-13 programs delivered in UK community settings under service level conditions. METHODS: The study employed an uncontrolled pre-follow-up design. A total of 165 children were measured. Outcomes included anthropometry, parental perception of emotional distress, body esteem, and self-esteem. RESULTS: Overall, there were significant improvements in all outcomes apart from BMI z-score. In boys, BMI z-score, waist circumference z-score, and psychometrics all improved. In girls, there were no statistically significant differences at 2.4 years, except for body esteem. CONCLUSIONS: In real-world settings, the MEND intervention, when delivered by nonspecialists, may result in modest, yet positive, long-term outcomes. Subsequent research should focus on improving the outcome effect size, providing effective behavior change maintenance strategies, and further investigating the reasons behind the observed gender differences.

Is BMI alone a sufficient outcome to evaluate interventions for child obesity?

BACKGROUND: BMI is often used to evaluate the effectiveness of childhood obesity interventions, but such interventions may have additional benefits independent of effects on adiposity. We investigated whether benefits to health outcomes following the Mind, Exercise, Nutrition…Do It! (MEND) childhood obesity intervention were independent of or associated with changes in zBMI. METHODS: A total of 79 obese children were measured at baseline; 71 and 42 participants were followed-up at 6 and 12 months respectively, and split into four groups depending on magnitude of change in zBMI. Differences between groups for waist circumference, cardiovascular fitness, physical and sedentary activities, and self-esteem were investigated. RESULTS: Apart from waist circumference and its z-score, there were no differences or trends across zBMI subgroups for any outcome. Independent of the degree of zBMI change, benefits in several parameters were observed in children participating in this obesity intervention. CONCLUSION: We concluded that isolating a single parameter like zBMI change and neglecting other important outcomes is restrictive and may undermine the evaluation of childhood obesity intervention effectiveness.

Randomized controlled trial of the MEND program: a family-based community intervention for childhood obesity.

The aim of this study was to evaluate the effectiveness of the Mind, Exercise, Nutrition, Do it (MEND) Program, a multicomponent community-based childhood obesity intervention (www.mendcentral.org). One hundred and sixteen obese children (BMI >or= 98 th percentile, UK 1990 reference data) were randomly assigned to intervention or waiting list control (6-month delayed intervention). Parents and children attended eighteen 2-h group educational and physical activity sessions held twice weekly in sports centers and schools, followed by a 12-week free family swimming pass. Waist circumference, BMI, body composition, physical activity level, sedentary activities, cardiovascular fitness, and self-esteem were assessed at baseline and at 6 months. Children were followed up 12 months from baseline (0 and 6 months postintervention for the control and intervention group, respectively). Participants in the intervention group had a reduced waist circumference z-score (-0.37; P < 0.0001) and BMI z-score (-0.24; P < 0.0001) at 6 months when compared to the controls. Significant between-group differences were also observed in cardiovascular fitness, physical activity, sedentary behaviors, and self-esteem. Mean attendance for the MEND Program was 86%. At 12 months, children in the intervention group had reduced their waist and BMI z-scores by 0.47 (P < 0.0001) and 0.23 (P < 0.0001), respectively, and benefits in cardiovascular fitness, physical activity levels, and self-esteem were sustained. High-attendance rates suggest that families found this intensive community-based intervention acceptable. Further larger controlled trials are currently underway to confirm the promising findings of this initial trial.