Collaborate2Lose: Collaborating with romantic and non-romantic support persons to improve long-term weight loss

背景：超过40%的退伍军人患有肥胖，肥胖是多种慢性病的危险因素。体重减轻 干预措施在临床上能显著减轻体重，但体重回升通常是由于体重下降所致。 坚持改变生活方式。这些变化往往会受到家里其他人的很大影响。因此， 让退伍军人和同居支持人员参与体重管理工作可以改善长期- 减肥这一术语。拟议的试验的目标是评估涉及浪漫和非浪漫的 在体重管理努力中为退伍军人长期减肥提供浪漫支持的人。 意义：这项研究将有助于我们的长期目标，即实施有效的方法来减少 退伍军人中的肥胖和相关的合并症。该提案涉及卫生服务研究和 可获得性、初级保健实践、虚拟保健和研究与办公室的发展重点 优先发展为退伍军人提供高质量的临床试验。重要的是 在2016年的一项最先进的调查中，强调了确定有效的减肥保持策略 体重管理会议。 创新：我们将大幅提升前期工作和行动！通过退伍军人管理局提供的计划1) 教退伍军人和他们的支持人员应用沟通和支持技能来支持退伍军人 体重管理和2)注重长期减肥。 具体目标：目标1：比较患者专属干预和伴侣辅助干预对长期体重的影响 损失(主要结果)和特定于肥胖的生活质量(次要结果)。我们的主要假设是 从临床上看，退伍军人的平均体重减轻幅度将至少高出3个百分点 有意义的差异，在72周时，伴侣辅助的手臂比只有患者的手臂更有意义。目标2：评估 相互依赖理论结构的变化在多大程度上调节了早期干预效果 (动机转换、夫妻效能、结果预期和社会支持)。目标3：评估 行动中的适当性、可接受性和可行性的实施结果！协调员通过 经过验证的调查和定性访谈，并在以下子集中评估治疗接受和制定 参与的退伍军人和支持人员通过定性访谈。 研究方法：这是一项双臂随机试验。参与者：由一名肥胖退伍军人和一名 同居的成人支持人。干预：指标性患者将参与基于群体的体重 管理计划使用退伍军人事务部(VA)全国移动！体重管理课程和 使用VA虚拟技术平台VA Video Connect交付。支持人员将参加会议， 而二人组将学习和练习沟通技能。比较：退伍军人将参加重量比赛 没有支持人员的管理计划。结果：主要结果是体重减轻的百分比 基线。时间：干预时间为72周。结果将在基线和每24小时进行评估 周，以72周为主要终点。 执行：我们将评估搬家！协调人对干预适当性的看法， 目标3中的可接受性、可行性和退伍军人待遇收据和颁布。 信息，我们将做好准备研究未来的实施情况。在这项研究中开发的材料 可以通过Move作为一个可选模块进行分发和实施！协调人。

Background: Over 40% of Veterans have obesity, a risk factor for multiple chronic diseases. Weight loss interventions produce clinically significant weight loss, yet weight regain commonly occurs due to declining adherence to lifestyle changes. These changes are often substantially influenced by others in the home. Thus, involving both Veterans and a cohabiting support person in weight management efforts could improve long- term weight loss. The goal of the proposed trial is to evaluate the efficacy of involving romantic and non- romantic support persons in weight management efforts to sustain long-term weight loss in Veterans. Significance: This study will contribute to our long-term goal of implementing effective approaches to reduce obesity and associated comorbidities among Veterans. This proposal addresses Health Services Research & Development priorities of access, primary care practice, and virtual care and Office of Research & Development priority of providing Veterans with access to high-quality clinical trials. The importance of identifying efficacious strategies for weight loss maintenance was highlighted in a 2016 State-of-the-Art conference on weight management. Innovation: We will substantially enhance prior work and the MOVE! program offered through the VA by 1) teaching Veterans and their support persons to apply communication and support skills to support Veteran weight management and 2) focusing on long-term weight loss. Specific Aims: Aim 1: Compare effects of patient-only and partner-assisted interventions on long-term weight loss (primary outcome) and obesity-specific quality of life (secondary outcome). Our primary hypothesis is that average weight loss from baseline among Veterans will be at least 3 percentage points greater, a clinically meaningful difference, in the partner-assisted arm than the patient-only arm at 72 weeks. Aim 2: Evaluate the extent to which early intervention effects are mediated by changes in interdependence theory constructs (transformation of motivation, couple efficacy, outcome expectancy, and social support). Aim 3: Evaluate implementation outcomes of appropriateness, acceptability, and feasibility among MOVE! Coordinators via validated surveys and qualitative interviews, and evaluate treatment receipt and enactment among a subset of participating Veterans and support persons via qualitative interviews. Methodology: This is a two-arm randomized trial. Participants: Dyads comprising a Veteran with obesity and a cohabiting adult support person. Intervention: Index patients will participate in a group-based weight management program using the Veterans Affairs (VA) national MOVE! weight management curriculum and delivered using the VA virtual technology platform, VA Video Connect. Support persons will join the sessions, and dyads will learn and practice communication skills. Comparison: Veterans will participate in the weight management program without a support person. Outcomes: The primary outcome is percent weight loss from baseline. Time: The intervention is 72 weeks in duration. Outcomes will be assessed at baseline and every 24 weeks, with 72 weeks as the primary endpoint. Implementation: We will assess MOVE! coordinator perceptions of intervention appropriateness, acceptability, and feasibility and Veteran treatment receipt and enactment in Aim 3. Armed with this information, we will be poised to study implementation in the future. The materials developed in this study could be disseminated and implemented as an optional module by MOVE! Coordinators.