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. 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. This 12-month, single-arm prospective study enrolled adults aged 21 to 65 years with BMI ≥27kg/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. Overall, 107 participants (n=96, 89.7% female; mean baseline BMI 35.4, SD 5.4kg/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 month1) and Barriers to Being Active Quiz (improvements at months3 and 6). Surveys showed high levels of engagement with and acceptability of the DBCCI. 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. ClinicalTrials.gov NCT05884606; https://clinicaltrials.gov/study/NCT05884606.
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