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

采用循证互动肥胖治疗方法 (iOTA) 预防早期严重精神疾病的肥胖：iOTA-eSMI

• 批准号: 9807090
• 负责人: JOHN W. NEWCOMER
• 金额: $ 22.97万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-15 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9807090
• 关键词: Address; Adherence; Adult; Antipsychotic Agents; Attenuated; Awareness; Behavior Therapy; Body Weight; Body Weight Changes; Body Weight decreased; Cardiovascular Diseases; Caregivers; Caring; Centers for Population Health; Chronic; Client; Community Mental Health Centers; Computers; Data; Development; Diet; Early treatment; Eating; Effectiveness; Enrollment; Environment; Evaluation; FDA approved; Face; Feasibility Studies; Florida; Focus Groups; Future; General Population; Goals; Group Interviews; Health; Health education; Individual; Internet; Intervention; Label; Low Income Population; Low income; Measures; Medical; Mental disorders; Methods; Missouri; National Institute of Mental Health; Neighborhood Health Center; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Online Systems; Outcome; Overweight; Parents; Participant; Patients; Persons; Pharmacotherapy; Phase; Pilot Projects; Population; Populations at Risk; Premature Mortality; Prevention; Process; Provider; Psychologist; Psychophysics; Randomized; Research Domain Criteria; Sampling; Self Efficacy; Serious Adverse Event; Social Processes; System; Technology; Testing; Text; Text Messaging; Treatment Effectiveness; Visit; Weight Gain; Workplace; Youth; adverse event risk; aged; attenuation; base; cardiovascular disorder prevention; career; cognitive system; cost effectiveness; design; diabetes prevention program; digital; effective intervention; evidence base; expectation; experience; health training; implementation science; insight; interest; lifestyle intervention; medication compliance; obesity prevention; obesity treatment; person centered; prevent; professional atmosphere; psychosocial; racial diversity; response; secondary analysis; severe mental illness; skills; visit adherence

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

项目概要/摘要 修订后的 R34 是对 RFA-MH-18-706、NIMH 对数字健康的持续兴趣以及对 事先审查。大多数肥胖和严重精神疾病 (SMI) 的相关并发症发生在 慢性精神疾病。逆转慢性 SMI 肥胖的行为干预面临着长期的挑战 术语有效性、实施性和可持续性。药物治疗仅限于标签外治疗 具有适度的有效性和/或严重的不良事件风险。该应用程序的重点是预防 通过调整和试点测试以预防为中心的交互式肥胖治疗方法来治疗慢性肥胖 (iOTA) 用于早期体重增加、超重或早期 SMI (eSMI) 患者 I 级肥胖。干预措施将改编自研究最多、有效的 iOTA（例如，24 岁时体重减轻） 月），源自糖尿病预防计划。计划的调整涉及 eSMI、预防 （重点关注体重增加衰减）和 RDoC 相关目标机制参与。直系父辈 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 SMS 消息传递是低收入人群中广泛使用的技术，以增加 干预参与度、有效性和成本效益。使用正式的评估流程和具体的 实施科学框架，计划对该应用程序进行调整，解决 eSMI、预防和 RDoC 相关目标机制参与，假设健康相关意识、洞察力和 食物摄入和活动的自我效能。我们的首要目标是适应和试点可扩展的、可持续的、 以预防为重点的 iOTA，适用于广泛的社区心理健康中心 (CMHC) 人群 患有 eSMI 的高危人群，计划在功能齐全的 RCT 中进行未来有效性测试，并且 最终大规模实施。 具体目标 1：评估干预参与、有效性和影响的障碍和促进因素 实施，并确定对先前的 iOTA 进行必要的修改，以用于 eSMI 中的肥胖衰减。 具体目标 2：调整先前的 iOTA 以用于 eSMI 中的肥胖衰减，旨在最大限度地提高可接受性， eSMI 的参与度、可持续影响力和目标参与度。 具体目标 3：在不同的成人样本中进行 iOTA-eSMI 的随机试点和可行性研究 年龄 18-45 岁，患有 eSMI 且初始体重增加、超重或早期 I 级肥胖，将 iOTA-eSMI 与 健康教育控制情况。本研究的目的是衡量可行性、可接受性、耐受性和 目标参与度，探索 iOTA-eSMI 与基线相比对体重变化的影响 控制。二次分析将评估 iOTA 对与所需心理物理学相关的 RDoC 领域的影响 技能和自我效能，探索体重变化和目标参与度之间的关系。 1