Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Serious Mental Illness
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Washington University School of Medicine
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| 追踪信息 | |||
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| 首次提交日期 ICMJE | October 2, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | July 5, 2018 | ||
| 预计主要完成日期 | March 31, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Change in Body Mass Index (BMI)[ Time Frame: Baseline and 16 Weeks ] Weight in kilograms and height in meters will be measured and combined to calculate BMI in kg/mˆ2 at baseline and following 16 weeks of participation in either an Interactive Obesity Treatment Approach (iOTA) program or a Health Education Program. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Serious Mental Illness | ||
| 正式标题 ICMJE | Adaptation of an Evidence-based Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Serious Mental Illness | ||
| 简要概况 | The proposed project aims to pilot and adapt a scalable and sustainable interactive obesity treatment approach (iOTA) program for adults with serious mental illness (SMI). The project consists of 2 arms: the iOTA SMI arm and the Health Education Control Group arm. The investigators hypothesize that participants in the iOTA intervention group will show favorable change in BMI compared to participants in the Health Education Control group, and participants in the iOTA intervention group will show favorable change in self efficacy with respect to healthy eating and activity compared to those in the Health Education Control group. |
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| 详细说明 | Obesity is highly prevalent among chronically-treated individuals with severe mental illness (SMI), exceeding general population rates and contributing to type 2 diabetes, cardiovascular disease (CVD) and premature mortality. Behavioral interventions to reverse obesity in chronic SMI have shown limited effectiveness. There are currently no FDA-approved pharmacotherapies for obesity in SMI, and off-label pharmacotherapies used for weight loss are associated with limited effectiveness or serious adverse event risks. Prior obesity interventions for SMI have often been designed for delivery by existing community mental health center (CMHC) caseworkers/staff. However, mental health workers commonly perceive themselves as overworked and/or career-specialized for psychological rather than medical care, creating barriers to sustainable provider engagement. Using a design-for-dissemination approach, initial development of the intervention under study incorporated trained health coaches using scalable, inexpensive technology to increase intervention engagement, effectiveness, sustainable reach and cost-effectiveness. Derived from the effective lifestyle intervention used in the Diabetes Prevention Program, the initial parent Interactive Obesity Treatment Approach (iOTA) intervention targets diet, activity and medication adherence, incorporating electronic (e.g., web-based) and interpersonal health coach support. That parent iOTA produces weight loss at 24 months in low-income, racially diverse, community health center populations with obesity, and became a platform for further adaptations of iOTA interventions for other populations and environments, targeting low-income populations with limited web and computer access. Using a formal evaluation process and implementation science framework, the parent iOTA intervention was subsequently adapted to low-income workplace environments, (the Working for You or WfY study, RO1 DK103760; PI: Evanoff) amplifying face-to-face health coach and peer interactions with interactive, semi-automated SMS text messaging, a highly utilized technology among low-income populations. The investigators further adapted the WfY iOTA for use in adults with chronic SMI using Innovation Corps (I-Corps) methods. Created by the National Science Foundation (NSF) and supported by NIH (PA-18-314), I-Corps uses the Lean Launchpad approach developed by serial entrepreneurs at Stanford for translating academic innovation into practice. The emphasis is on immediate and iterative elicitation of stakeholder feedback via focus groups or short interviews. Using stakeholder input, investigators revise assumptions and hypotheses, testing redesigned offerings and making adjustments to ideas that are not working. In conducting our interviews, we identified "customer" specific (e.g. client, clinician and administrator) barriers to implementation of an un-adapted iOTA in mental health treatment centers. Themes that consistently emerged were concern about limited human resources and added work burden not directly related to the mental health of clients, while clients expressed a desire for more in-person and telephonic coaching time, in addition to text messaging. Now, the investigators propose to use an overarching treatment adaptation framework18 to further refine our treatment to be more readily implementable for individuals with chronic SMI treated in the CMHC setting. Reproducible adaptation of effective interventions to new target populations and settings requires a formal evaluation process and an implementation science framework. Our overarching aim for this application is to pilot and iteratively adapt a scalable and sustainable iOTA for adults with SMI, planning for future effectiveness testing in a well-powered randomized controlled trial (RCT), and eventual large scale dissemination and implementation. Aim 1: Conduct a randomized pilot and feasibility study of iOTA-SMI in a diverse sample of adults with chronic SMI, comparing iOTA-SMI to a health education control condition. iOTA-SMI will be piloted in a representative sample of 40 adults ages 18-60 with SMI, randomizing participants 2:1 to 16 weeks of iOTA-SMI versus monthly health education. We hypothesize favorable differences in BMI for iOTA-SMI compared to control. Secondary analyses will assess iOTA effects on health self-efficacy, exploring the relationship between effects on Body Mass Index (BMI) and the target mechanism. Aim 2: Evaluate feasibility and acceptability of iOTA implementation, making iterative adaptations based on data collected during the pilot. Feasibility, engagement and implementation challenges will be characterized, measured by i) enrollment and retention, ii) obesity intervention acceptability, iii) text response rates, iv) visit adherence v) client expectations, vi) fidelity and vii) CMHC staff-rated acceptability, appropriateness and burden. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
40 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | June 30, 2019 | ||
| 预计主要完成日期 | March 31, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - aged 18-60 years - BMI ≥ 28 - have a diagnosis of a severe and persistent mental illness - psychiatric symptoms present for at least 6 months prior to screening - at least 6 months of lifetime antipsychotic exposure prior to screening - not taking weight loss medications or participating in another behavioral weight loss intervention - enrolled in case management services - able to provide written informed consent Exclusion Criteria: - acute suicidality at time of screening - active substance use disorder diagnosis - unable or unwilling to provide written informed consent | ||
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| 年龄 | 最小年龄：18 Years ，最大年龄：60 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Washington University School of Medicine | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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