Teaching Obesity Treatment Options to Adult Learners (TOTAL): A Multi-site RCT

向成人学习者教授肥胖治疗方案（总计）：多中心随机对照试验

• 批准号: 10424975
• 负责人: Luke M Funk
• 金额: --
• 依托单位: WM S. MIDDLETON MEMORIAL VETERANS HOSP
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10424975
• 关键词: Address; Adult; Age; Attitude; Awareness; Behavior; Behavior Therapy; Behavioral; Body Weight Changes; Body Weight decreased; Body mass index; Caring; Clinical; Consolidated Framework for Implementation Research; Cost Analysis; Decision Making; Development; Dietary intake; Drug Prescriptions; Educational process of instructing; Electronic Health Record; Elements; Evaluation; Evidence based treatment; Expenditure; Future; Goals; Health; Health Promotion; Health Services Accessibility; Health behavior; Healthcare Systems; Hypertension; Improve Access; Intervention; Interview; Knowledge; Lead; Malignant Neoplasms; Measures; Medical; Medical center; Methodological Studies; Modeling; Motivation; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Office Surgery; Outcome; Outcome Assessment; Overweight; Participant; Patients; Pharmaceutical Preparations; Physical activity; Preparation; Protocols documentation; Provider; Quality of life; Randomized; Randomized Controlled Trials; Reach Effectiveness Adoption Implementation and Maintenance; Research; Research Personnel; Research Priority; Resources; Schedule; Site; Surveys; System; Technology; Telemedicine; Telephone; Testing; Treatment Effectiveness; Veterans; Visit; Weight maintenance regimen; Work; bariatric surgery; barrier to care; care recipients; comorbidity; compare effectiveness; cost; disorder prevention; effective therapy; effectiveness evaluation; evidence base; implementation cost; improved; innovation; military veteran; novel; obesity risk; obesity treatment; operation; pharmacy benefit; pilot test; population based; population health; post intervention; primary outcome; programs; randomized trial; recruit; retention rate; secondary outcome; symposium; telehealth; therapy design; treatment as usual

Background: Nearly 80% of Veterans meet criteria for overweight (body mass index [BMI] of 25-29.9 kg/m2) or obesity (BMI≥30). VA offers three evidence-based obesity treatments at little to no cost to Veterans: MOVE! (to improve dietary intake and physical activity through behavioral modification); obesity medications; and bariatric surgery, but all are significantly underutilized: <10% of Veterans with obesity participate in MOVE!; 2% receive obesity medications; and 0.3% of those who meet BMI criteria for bariatric surgery (BMI≥35) undergo it. There is an urgent need to increase use of all three treatments to improve Veteran health. Significance/Impact: Nearly 4,000,000 Veterans meet BMI criteria for overweight/obesity. It is essential that Veterans with overweight/obesity are aware of the three treatment options and are motivated to pursue them. Currently, no interventions in VA seek to increase use of all three evidence-based obesity treatment options for Veterans not currently participating in MOVE!. The TOTAL intervention (Teaching Obesity Treatment Options to Adults Learners), if effective, would increase obesity treatment initiation for Veterans, lead to greater weight loss, and improve quality of life. Given that TOTAL is deliverable via VA telemedicine, it could be implemented throughout the VA healthcare system without requiring significant resources and could be integrated into the existing VA behavioral weight management program, MOVE!. Innovation: The research in this proposal would be the first adequately powered RCT in VA testing an intervention to increase use of all three evidence-based obesity treatments: MOVE!, obesity medications, and bariatric surgery. It would leverage the power of the VA electronic health record and would improve access to care by expanding use of a recently developed telemedicine technology – VA Video Connect (VVC) – which was developed by VA researchers. It could be implemented and disseminated efficiently within VA given that MOVE! is available at every VAMC and is supported by NCP. Specific Aims: Aim 1: Compare the effectiveness of TOTAL vs. usual care for increasing obesity treatment initiation among Veterans with overweight/obesity who are not participating in MOVE!; Aim 2: Compare the effectiveness of TOTAL vs. usual care for increasing sustained MOVE! participation, receipt of an obesity medication prescription or bariatric surgery referral, and weight loss; Aim 3: Inform future dissemination efforts of TOTAL via interviews with key stakeholders, a “Reach” analysis, and cost analysis. Methodology: Study population: Veterans at two VAMCs, age 18-75 with a BMI ≥30 or 27-29.9 + an obesity- related comorbidity who have not had a MOVE! visit within the past 12 months and thus are not participating in obesity treatment will participate in the RCT; Intervention: The TOTAL intervention consists of an 18-minute obesity treatment educational video and three motivational sessions (all delivered via VA Video Connect [VVC]); Comparison: Usual care (Veterans who have not had a MOVE! visit in the previous 12 months); Outcomes: MOVE! initiation, sustained MOVE! participation, obesity medication use, bariatric surgery referral, weight change; Timing: Primary and secondary outcomes will be measured 18 months post-randomization. Implementation/Next Steps: Facilitators and barriers to TOTAL implementation will be assessed in Aim 3 interviews with Veteran, provider, and operations stakeholders using the Consolidated Framework for Implementation Research (CFIR). [We will also perform “reach” and cost analyses. We will collaborate with NCP to disseminate TOTAL to all VAMCs that have a MOVE! program. The National MOVE! Director will present study results on a national MOVE! call and make presentation materials available on the national MOVE! SharePoint dissemination site. The National MOVE! Director will support MOVE! coordinators who work directly with health behavior coordinators at every VAMC with MOVE!. The study team will consider partnering with NCP to conduct a QUERI National Partnered Evaluation evaluating how TOTAL can be implemented throughout VA.

背景：近80%的退伍军人符合超重标准（体重指数[BMI]为25-29.9 kg/m2）或 肥胖（BMI≥30）。退伍军人管理局提供了三个以证据为基础的肥胖治疗，几乎没有成本退伍军人：移动！（至 通过行为改变改善饮食摄入和身体活动）;肥胖症药物;和减肥药 手术，但都是显着利用不足：<10%的退伍军人与肥胖参与移动！2%收到 肥胖药物; 0.3%符合减肥手术BMI标准（BMI≥35）的人接受了减肥手术。 迫切需要增加这三种治疗方法的使用，以改善退伍军人的健康状况。 意义/影响：近400万退伍军人符合超重/肥胖的BMI标准。至关重要的是 超重/肥胖的退伍军人知道这三种治疗方案，并有动力去追求它们。 目前，没有任何VA干预措施寻求增加所有三种循证肥胖治疗方案的使用， 目前没有参加MOVE的退伍军人！全面干预（教授肥胖治疗方案， 成人学习者），如果有效，将增加肥胖治疗开始退伍军人，导致更大的体重减轻， 提高生活质量。鉴于TOTAL可通过VA远程医疗交付，因此可以实施 在整个VA医疗保健系统中，无需大量资源，并且可以集成到 现有的VA行为体重管理计划，移动！ 创新：本提案中的研究将是第一个在VA测试中具有充分效力的RCT， 增加所有三种循证肥胖治疗方法使用的干预措施：MOVE！，肥胖药物，以及 减肥手术它将利用VA电子健康记录的力量，并将改善对 通过扩大使用最近开发的远程医疗技术- VA视频连接（VVC）， 由VA研究人员开发。它可以在VA内有效地实施和传播，因为MOVE！ 每个VAMC都提供，并由NCP提供支持。 具体目标：目标1：比较TOTAL与常规护理对增加肥胖治疗的有效性 在未参加MOVE！的超重/肥胖退伍军人中启动;目标2：比较 TOTAL与常规护理的有效性，以增加持续的MOVE！参与，接受肥胖 药物处方或减肥手术转诊和减肥;目标3：告知未来的传播工作 通过与关键利益相关者的访谈、“范围”分析和成本分析， 方法学：研究人群：两个VAMC的退伍军人，年龄18-75岁，BMI ≥30或27-29.9 +肥胖- 相关的comoremons谁没有动！在过去12个月内访问，因此没有参加 肥胖治疗将参与RCT;干预：总干预包括18分钟的 肥胖治疗教育视频和三个激励会议（全部通过VA视频连接[VVC]提供）; 比较：医疗保健（退伍军人谁没有移动！过去12个月内的访视）;结局： 动起来！启动，持续移动！参与，肥胖药物使用，减肥手术转诊，体重 变化;时间：将在随机化后18个月测量主要和次要结局。 实施/后续步骤：目标3将评估实施TOTAL的促进因素和障碍 使用整合框架采访退伍军人、提供商和运营利益相关者， 实施研究（CFIR）。[We还将进行“覆盖范围”和成本分析。我们将与NCP合作 向所有有行动的VAMC传播TOTAL！程序.全国搬家！导演将介绍 研究结果在全国移动！打电话，使演示材料可在国家移动！ SharePoint传播站点。全国搬家！导演支持MOVE！直接工作的协调员 与健康行为协调员在每个VAMC与移动！研究小组将考虑与NCP合作 进行QUERI国家合作评估，评估如何在整个VA实施TOTAL。