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

Collaborate2Lose：与浪漫和非浪漫支持人员合作，以改善长期减肥效果

• 批准号: 10424742
• 负责人: Corrine Ione Voils
• 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: 2022-07-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10424742
• 关键词: Address; Adherence; Adult; Behavior Therapy; Behavioral; Body Weight decreased; Cholesterol; Chronic Disease; Clinical; Clinical Trials; Cognitive; Communication; Counseling; Couples Therapy; Dietary intake; Early Intervention; Educational Curriculum; Educational process of instructing; Exercise; Expectancy; Feeling; Future; Goals; Health; Health Care Costs; Health Services Research; Health behavior change; Home; Individual; Intervention; Interview; Joints; Learning; Life Style; Maintenance; Mediating; Mediator of activation protein; Medical; Methodology; Motivation; Obesity; Outcome; Participant; Patient-Focused Outcomes; Patients; Perception; Persons; Physical activity; Prevalence; Primary Health Care; Problem Solving; Quality of life; Randomized; Risk Factors; Social Environment; Social Network; Social support; Spouses; Surveys; Thinking; Time; United States Department of Veterans Affairs; Veterans; Weight; Weight maintenance regimen; Work; arm; base; clinically significant; comorbidity; dietary; efficacy evaluation; efficacy outcomes; evidence base; experience; future implementation; implementation evaluation; implementation outcomes; improved; indexing; innovation; insight; intervention effect; lifestyle intervention; primary endpoint; primary outcome; programs; randomized trial; research and development; secondary outcome; skills; success; symposium; theories; treatment as usual; two-arm trial; virtual; virtual healthcare; virtual technology; weight loss intervention

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.

背景：超过40％的退伍军人患有肥胖症，这是多种慢性疾病的危险因素。减肥 干预措施会产生临床上明显的体重减轻，但由于下降而通常会重新恢复体重 遵守生活方式的改变。这些变化通常受到家庭中其他人的影响。因此， 参与退伍军人和同居的支持人员参与体重管理工作可以改善长期 定期减肥。拟议试验的目的是评估涉及浪漫和非 - 体重管理方面的浪漫支持人员为维持退伍军人的长期体重减轻。 意义：这项研究将有助于我们实施有效方法以减少的长期目标 退伍军人之间的肥胖和相关合并症。该建议涉及卫生服务研究和 发展优先级，初级保健实践和虚拟护理以及研究办公室 为退伍军人提供高质量临床试验的发展优先级。重要性 在2016年最先进 体重管理会议。 创新：我们将显着增强先前的工作和举动！通过VA提供的计划1） 教退伍军人及其支持人员运用沟通和支持技能来支持退伍军人 体重管理和2）专注于长期体重减轻。 具体目的：目标1：比较仅患者和伴侣辅助干预措施对长期体重的影响 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 退伍军人中基线的平均体重减轻至少要大3个百分点，临床上 有意义的差异，在伴侣辅助手臂中，仅在72周时与患者的手臂相比。目标2：评估 相互依赖理论构造的变化介导早期干预效应的范围 （动机的转变，夫妇疗效，预期和社会支持）。目标3：评估 移动之间适当性，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，并评估了一部分 通过定性访谈参与退伍军人和支持人员。 方法论：这是一项两臂随机试验。参与者：由肥胖和一个老兵组成的二元组 同居成人支持人员。干预：指数患者将参加基于组的体重 使用退伍军人事务（VA）国家举动的管理计划！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， 二元组将学习和练习沟通技巧。比较：退伍军人将参加体重 没有支持人员的管理计划。结果：主要结果是减肥百分比减轻 基线。时间：干预时间为72周。结果将在基线和每24个评估 周，作为主要终点，有72周。 实施：我们将评估移动！干预适当性的协调员看法， AIM 3中的可接受性，可行性和资深治疗收据和颁布。 信息，我们将未来研究实施。本研究中开发的材料 可以通过移动传播并作为可选模块实现！协调员。