PDF(Pubmed)
Abstract：
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.
BACKGROUND: ClinicalTrials.gov NCT05884606; https://clinicaltrials.gov/study/NCT05884606.
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.
BACKGROUND: ClinicalTrials.gov NCT05884606; https://clinicaltrials.gov/study/NCT05884606.
摘要：
背景：数字健康干预显示了体重管理的希望。然而,很少有基于文本的行为改变干预措施被设计来支持接受胃内气球的患者，没有人同时评估体重减轻，心理健康，和行为改变，尽管这些因素在体重管理中至关重要的相互作用。
目的：本研究旨在评估健康教练领导的异步，基于文本的数字行为改变教练干预（DBCCI）提供给参与者接受胃内球囊和其后续护理计划是可行的和可接受的参与者，并支持改善的结果，包括减肥,心理健康，和生活方式行为的改变有利于减肥维持。
方法：这12个月，单臂前瞻性研究纳入了在英国和荷兰的5家减肥诊所接受无手术胃内球囊(PIGB)的21~65岁BMI≥27kg/m2的成年人.参与者在PIGB放置后6个月接受DBCCI和诊所主导的PIGB后续护理计划（远程交付），然后在另外6个月没有干预。DBCCI是基于证据的，个性化干预,其中健康教练通过交换异步应用内基于文本的消息支持参与者.在12个月的研究中，我们通过自我管理的有效问卷评估了总体体重减轻和心理健康的百分比（华威-爱丁堡精神健康量表，广义焦虑症量表，体重对生活质量的影响-精简版临床试验版本，对饮食失去控制的规模-简介，体重功效生活方式问卷-简表，和成为主动测验的障碍)。通过自我报告的调查评估参与者对干预措施的参与度和可接受性。
结果：总体而言，107名参与者（n=96，89.7％为女性；平均基线BMI35.4，SD5.4kg/m2）纳入分析。在DBCCI结束时平均总体重减轻为13.5%(SEM为2.3%),在12个月随访时平均总体重减轻为11.22%(SEM为2.3%)(P<.001)。在整个12个月中，除广泛性焦虑症量表（第1个月改善）和主动测验障碍（第3和6个月改善）外，所有心理健康指标均得到改善。调查显示，与DBCCI的参与度和可接受性很高。
结论：这项研究提供了证据，异步，基于文本的DBCCI对超重和肥胖的参与者具有吸引力和可接受性.DBCCI与PIGB及其善后计划一起交付，与基线相比,支持改善体重减轻结局和心理健康,并且与已知有助于实现和维持长期体重减轻和改善健康结局的生活方式行为改变相关.后续调查结果表明，潜在的长期需求，更紧张的教练专注于减肥维护和支持正在进行的自我教练。这可以通过利用生成人工智能来提供持续的自动化行为改变指导支持来实现，以增强人类主导的护理。
背景：ClinicalTrials.govNCT05884606;https://clinicaltrials.gov/study/NCT05884606。
目的：本研究旨在评估健康教练领导的异步，基于文本的数字行为改变教练干预（DBCCI）提供给参与者接受胃内球囊和其后续护理计划是可行的和可接受的参与者，并支持改善的结果，包括减肥,心理健康，和生活方式行为的改变有利于减肥维持。
方法：这12个月，单臂前瞻性研究纳入了在英国和荷兰的5家减肥诊所接受无手术胃内球囊(PIGB)的21~65岁BMI≥27kg/m2的成年人.参与者在PIGB放置后6个月接受DBCCI和诊所主导的PIGB后续护理计划（远程交付），然后在另外6个月没有干预。DBCCI是基于证据的，个性化干预,其中健康教练通过交换异步应用内基于文本的消息支持参与者.在12个月的研究中，我们通过自我管理的有效问卷评估了总体体重减轻和心理健康的百分比（华威-爱丁堡精神健康量表，广义焦虑症量表，体重对生活质量的影响-精简版临床试验版本，对饮食失去控制的规模-简介，体重功效生活方式问卷-简表，和成为主动测验的障碍)。通过自我报告的调查评估参与者对干预措施的参与度和可接受性。
结果：总体而言，107名参与者（n=96，89.7％为女性；平均基线BMI35.4，SD5.4kg/m2）纳入分析。在DBCCI结束时平均总体重减轻为13.5%(SEM为2.3%),在12个月随访时平均总体重减轻为11.22%(SEM为2.3%)(P<.001)。在整个12个月中，除广泛性焦虑症量表（第1个月改善）和主动测验障碍（第3和6个月改善）外，所有心理健康指标均得到改善。调查显示，与DBCCI的参与度和可接受性很高。
结论：这项研究提供了证据，异步，基于文本的DBCCI对超重和肥胖的参与者具有吸引力和可接受性.DBCCI与PIGB及其善后计划一起交付，与基线相比,支持改善体重减轻结局和心理健康,并且与已知有助于实现和维持长期体重减轻和改善健康结局的生活方式行为改变相关.后续调查结果表明，潜在的长期需求，更紧张的教练专注于减肥维护和支持正在进行的自我教练。这可以通过利用生成人工智能来提供持续的自动化行为改变指导支持来实现，以增强人类主导的护理。
背景：ClinicalTrials.govNCT05884606;https://clinicaltrials.gov/study/NCT05884606。
