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：将近80％的退伍军人符合超重的标准（体重指数[BMI] 25-29.9 kg/m2）或 肥胖（BMI≥30）。 VA对退伍军人几乎没有成本提供三种基于证据的肥胖症治疗：搬家！ （到 通过行为改变改善饮食摄入和体育锻炼）；肥胖药物；和减肥 手术，但所有人都没有得到明显未充分利用：<10％的退伍军人参加了移动！ 2％收到 肥胖药物；符合BMI减肥手术标准（BMI≥35）的人中有0.3％接受了这种情况。那里 迫切需要增加所有三种治疗方法以改善退伍军人健康。 意义/影响力：将近4,000,000名退伍军人符合超重/肥胖症的BMI标准。至关重要 超重/肥胖症的退伍军人意识到三种治疗选择，并有动力追求他们。 目前，VA的任何干预措施都没有寻求增加所有三种基于证据的肥胖治疗方案的使用 退伍军人目前未参加Move！全面干预（教肥胖治疗方案 成人学习者），如果有效，将增加对退伍军人的肥胖症治疗计划，从而导致体重减轻更大， 并改善生活质量。鉴于总数是通过VA远程医疗传递的，因此可以实施 在整个VA医疗保健系统中，不需要大量资源，可以将 现有的VA行为体重管理计划，移动！ 创新：该提案中的研究将是VA测试中的第一个足够动力的RCT 干预以增加所有三种基于证据的肥胖治疗的使用：移动！，肥胖药物和 减肥手术。它将利用VA电子健康记录的力量，并将提高进入 通过扩大最近开发的远程医疗技术的使用-VA视频连接（VVC） - 由VA研究人员开发。考虑到这一举动，它可以在VA内有效地实施和传播！ 每个VAMC可用，并由NCP支持。 具体目的：目标1：比较肥胖治疗的全部和通常护理的有效性 没有参加Move的退伍军人之间的启动！目标2：比较 持续移动增加的全部和通常护理的有效性！参与，接收客观性 药物处方或减肥手术转诊和体重减轻；目标3：告知未来的传播努力 通过与主要利益相关者的访谈，“覆盖范围”分析和成本分析的总访谈。 方法论：研究人群：两名VAMC的退伍军人，年龄18-75岁，BMI≥30或27-29.9 +肥胖症 - 没有动作的相关合并症！在过去的12个月内访问，因此没有参加 肥胖治疗将参加RCT；干预：总干预措施包括18分钟 肥胖治疗教育视频和三个动机会议（全部通过VA视频连接[VVC]提供）； 比较：通常的护理（从未采取行动的退伍军人！在过去的12个月中拜访）；结果： 移动！启动，持续的举动！参与，肥胖药物使用，减肥手术转诊，体重 改变;时机：随机化后18个月将测量主要和次要结果。 实施/下一步：将在AIM 3中评估促进者和全面实施的障碍 使用合并框架的资深人士，提供商和运营利益相关者的访谈 实施研究（CFIR）。 [我们还将执行“覆盖范围”和成本分析。我们将与NCP合作 将总计传播到所有有移动的VAMC！程序。民族举动！导演将在场 研究结果是针对民族举动的！致电并制作《国家举动》中的演示材料！ SharePoint传播网站。民族举动！导演将支持举动！直接工作的协调员 每一个VAMC都有健康行为协调员！研究团队将考虑与NCP合作 进行Queri国家合作评估，评估如何在整个VA中实施总计。