Adaptation of an Evidence-based Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Early Serious Mental Illness: iOTA-eSMI

项目摘要/摘要 修订后的R34符合RFA-MH-18-706、NIMH对数字健康的持续兴趣以及 事先审查。大多数严重精神疾病(SMI)的肥胖和相关并发症发生在 慢性精神疾病。慢性SMI患者逆转肥胖的行为干预面临长期挑战 任期有效性、执行力和可持续性。药物治疗仅限于标签外的治疗 具有适度的有效性和/或严重的不良事件风险。此应用程序侧重于预防 通过适应和试点以预防为重点的互动肥胖治疗方法来治疗慢性肥胖症 (IOTA)适用于经历早期体重增加、超重或早期体重增加的早期SMI(ESMI)患者 I类肥胖症。干预措施将根据研究最多的、有效的IOTA进行调整(例如，在24岁时减肥 几个月)，源自糖尿病预防计划。计划中的调整解决了ESMI，预防 (关注体重增加衰减)，以及与RDoC相关的目标机制参与。直系父母 此应用程序的IOTA使用健康教练，他们通过可扩展、廉价、 半自动短信，一项在低收入人群中使用率很高的技术，以增加 干预参与度、有效性和成本效益。使用正式的评估程序和具体的 实施科学框架、此应用程序的计划调整以解决ESMI、预防和 与RDoC相关的目标机制参与、假设提高了与健康相关的意识、洞察力和 食物摄入量和活动量的自我效能。我们的总体目标是适应和试点一个可扩展、可持续、 在广大社区精神卫生中心(CMHC)人口中使用以预防为重点的IOTA 患有ESMI的高危人群，计划在全功率随机对照试验中进行未来的有效性测试 最终大规模实施。 具体目标1：评估干预参与度、有效性和 实施，并确定在ESMI中用于减肥的先前IOTA的所需适应。 具体目标2：使先前的IOTA用于ESMI中的肥胖减轻，旨在最大限度地提高可接受性， ESMI的参与度、可持续覆盖范围和目标参与度。 具体目标3：在不同的成人样本中进行IOTA-ESMI的随机试验和可行性研究 年龄18-45岁，患有ESMI和最初体重增加、超重或早期I级肥胖的患者，将IOTA-ESMI与 健康教育控制情况。这项研究的目标是衡量可行性、可接受性、耐受性和 目标投入，探索IOTA-ESMI对基线体重变化的影响 控制力。二次分析将评估与所需心理物理相关的RDoC领域的IOTA影响 技能和自我效能感，探索体重变化和目标投入之间的关系。 1

Project Summary/Abstract This revised R34 is responsive to RFA-MH-18-706, to the ongoing NIMH interest in Digital Health, and to the prior review. Most obesity and related complications in serious mental illness (SMI) occur in the context of chronic psychiatric illness. Behavioral interventions to reverse obesity in chronic SMI face challenges with long- term effectiveness, implementation and sustainability. Pharmacotherapies are limited to off-label treatments with modest effectiveness and/or serious adverse event risks. This application focuses on prevention of chronic obesity by adapting and pilot testing a prevention-focused, interactive obesity treatment approach (iOTA) for use in persons with early-phase SMI (eSMI) experiencing initial weight gain, overweight or early class I obesity. The intervention will be adapted from the most studied, effective iOTA (e.g., weight loss at 24 months), derived from the Diabetes Prevention Program. Planned adaptations address eSMI, prevention (focus on weight gain attenuation), and RDoC-relevant target mechanism engagement. The immediate parent iOTA for this application uses health coaches who extend their sustainable reach with scalable, inexpensive, semi-automated SMS messaging, a highly-utilized technology among low-income populations, to increase intervention engagement, effectiveness and cost-effectiveness. Using a formal evaluation process and specific implementation science framework, planned adaptations for this application address eSMI, prevention, and RDoC-relevant target mechanism engagement, hypothesizing increased health-related awareness, insight and self-efficacy for food intake and activity. Our overarching aim is to adapt and pilot a scalable, sustainable, prevention-focused iOTA for use in the broad community mental health center (CMHC) population of at-risk persons with eSMI, planning for future effectiveness testing in a fully-powered RCT and eventual large scale implementation. Specific Aim 1: Evaluate barriers and facilitators for intervention engagement, effectiveness and implementation, and identify needed adaptations of the prior iOTA for use in obesity attenuation in eSMI. Specific Aim 2: Adapt the prior iOTA for use in obesity attenuation in eSMI, aiming to maximize acceptability, engagement, sustainable reach and target engagement for eSMI. Specific Aim 3: Conduct a randomized pilot and feasibility study of iOTA-eSMI in a diverse sample of adults aged 18-45 with eSMI and initial weight gain, overweight or early class I obesity, comparing iOTA-eSMI to a health education control condition. The goal of this study is to measure feasibility, acceptability, tolerability, and target engagement, exploring effects on change in body weight from baseline with iOTA-eSMI compared to control. Secondary analyses will assess iOTA effects on RDoC domains relevant to needed psychophysical skills and self-efficacy, exploring the relationship between weight change and target engagement. 1