The EMBER Trial for Weight Management Engagement

参与体重管理的 EMBER 试验

• 批准号: 10315463
• 负责人: Jessica Yelena Breland
• 金额: --
• 依托单位: VETERANS ADMIN PALO ALTO HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10315463
• 关键词: Address; Affect; Behavior; Behavioral; Belief; Body Weight decreased; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Color; Complications of Diabetes Mellitus; Data; Diabetes Mellitus; Disease; Dissemination and Implementation; Effectiveness; Ensure; Exercise; Food Services; Goals; Health; Health Promotion; Health Services Accessibility; Health Services Administration; Heart Diseases; Hybrids; Intervention; Interview; K-Series Research Career Programs; Letters; Malignant Neoplasms; Methodology; Methods; Modeling; Morbidity - disease rate; Motivation; Obesity; Organization and Administration; Outcome; Pain management; Paper; Participant; Patient Self-Report; Patient-Centered Care; Patients; Persons; Physical activity; Pilot Projects; Population; Primary Health Care; Quality of life; Randomized; Research; Research Design; Research Priority; Risk; Science; Self Efficacy; Self-Direction; Series; Services; Site; System; Testing; Time; Touch sensation; Translating; United States; United States Health Resources Administration; Veterans; Veterans Health Administration; Weight; Weight Gain; Weight maintenance regimen; Woman; Work; arm; base; behavioral health; comorbidity; cost; design; digital; disorder prevention; effectiveness implementation trial; flexibility; follow-up; health equity; health service use; high risk; high risk population; hybrid type 1 design; hybrid type 1 trial; hybrid type 2 trial; implementation outcomes; implementation science; implementation strategy; improved; innovation; interest; mortality; motivational enhancement therapy; novel; nutrition; obese patients; obesity risk; patient oriented; people of color; physical conditioning; population health; primary outcome; programs; secondary outcome; self help; severe COVID-19; smoking cessation; therapy design; tool; virtual healthcare

Background: Almost 40% of Veterans using the Veterans Health Administration (VA) have obesity, putting millions at risk for costly and debilitating conditions, including diabetes, cancer, and severe COVID-19. VA weight management programs effectively reduce weight, morbidity, and mortality. For example, MOVE!, VA’s flagship program for weight management is associated with reductions in cardiovascular disease and diabetes. However, while 94% of eligible Veterans are offered weight management programs, less than 8% use them. Motivational interviewing improves treatment engagement, but clinicians have limited time to apply it. Therefore, we developed EMBER, a self-directed tool with the goal of Enhancing Motivation for Better Engagement and Reach for weight management. It is available in paper and digital formats. EMBER is not a weight management program, instead it engages Veterans in existing programs by informing and guiding choices about weight management. EMBER is the product of an HSR&D Career Development Award (15-257). Significance: If EMBER increases engagement in effective weight management programs, it has the potential to help Veterans lose weight, thereby improving health and quality of life for thousands of patients. As a result, we address many HSR&D priorities, e.g., access to care, virtual care, healthy equity, & primary care. Innovation & Impact: EMBER is the first self-directed, motivational interviewing-based intervention designed to increase Veteran engagement in weight management programs. As opposed to a “one-off” study in a specific population, the proposed work takes a novel, low-touch population health approach that could be translated to other programs (e.g., behavioral pain management). EMBER also includes vignettes relevant to populations at high risk for obesity (e.g., women, people of color). Further, t he Hybrid Type 1 design will ensure results can be scaled and sustained while also advancing implementation science. As such, the proposed work will: 1) advance the science of engagement in behavioral health programs and 2) facilitate future research on the implementation of EMBER and similar interventions. Specific Aims: 1. Assess whether Veterans randomized to EMBER are more likely to have any weight management engagement at 2-month follow-up (per administrative data supplemented with self-report) compared to those randomized to the control arm (information sheet listing available programs). (Primary Outcome) 2. Assess whether Veterans randomized to EMBER have greater weight management program retention, weight management behaviors (e.g., physical activity), weight loss, and quality of life gains at 6-month follow-up compared to those randomized to the control arm. (Secondary Outcomes) 3. Assess factors likely to affect EMBER’s implementation. Preliminary implementation outcomes will be assessed via RE-AIM4 (Reach, Effectiveness, Implementation) and the Proctor et al.5 implementation outcomes framework (Acceptability, Appropriateness, Costs, Fidelity). (Implementation Outcomes) Randomized two site Hybrid Type 1 Effectiveness-Implementation Trial among Veteran primary care patients with obesity in VA (N=470). Participants will be randomized to EMBER or a control condition consisting of a list of available weight management programs. The primary outcome is any weight management engagement 2-months after baseline. Aims 1 and 2 will use self-report and administrative data to assess intervention outcomes. Aim 3 will use patient data and information from research staff. Methodology: Implementation/Next Steps: If effective, we will use implementation strategies suggested by Aim 3 to ensure Veterans receive EMBER. We will test these strategies in a Hybrid Type 2 trial to understand EMBER’s effectiveness in real world contexts and best practices for dissemination and implementation of EMBER and similar interventions.

背景：几乎40%的退伍军人使用退伍军人健康管理局（VA）有肥胖， 数以百万计的人面临昂贵和虚弱的疾病风险，包括糖尿病，癌症和严重的COVID-19。VA 体重管理计划有效地降低体重、发病率和死亡率。例如，MOVE！VA的 体重管理的旗舰计划与心血管疾病和糖尿病的减少有关。 然而，虽然94%的合格退伍军人提供体重管理计划，但只有不到8%的人使用它们。 动机性访谈提高了治疗参与度，但临床医生应用它的时间有限。 因此，我们开发了EMBER，这是一个自我导向的工具，其目标是增强动机， 参与和体重管理。它有纸质和数字格式。Ember不是一个 体重管理计划，而是通过告知和指导退伍军人参与现有的计划， 体重管理的选择。EMBER是HSR&D职业发展奖（15-257）的产物。 意义：如果EMBER增加有效体重管理计划的参与， 帮助退伍军人减肥，从而改善成千上万患者的健康和生活质量。因此，在本发明中， 我们处理许多HSR&D优先事项，例如， 获得保健、虚拟保健、健康公平和初级保健。 创新和影响：EMBER是第一个自我导向的，基于动机的面试干预设计， 增加退伍军人参与体重管理计划。与“一次性”研究不同， 具体人群，拟议的工作采取了一种新的，低接触的人口健康方法，可以 翻译成其它程序（例如，行为疼痛管理）。EMBER还包括与以下内容相关的小插曲： 肥胖症高危人群（例如，女人，有色人种）。 此外，t 混合1型设计将确保 成果可以扩大规模和持续，同时也可以推进执行科学。因此，拟议的工作 将：1）推进参与行为健康计划的科学，2）促进未来的研究， 实施应急、复原和评价系统及类似的干预措施。 具体目标： 1.评估随机分配到EMBER的退伍军人是否更有可能进行任何体重管理 2个月随访时的参与度（根据补充自我报告的管理数据）与 随机分配至对照组的受试者（信息表列出了可用的程序）。（主要结局） 2.评估随机分配到EMBER的退伍军人是否有更大的体重管理计划保留， 体重管理行为（例如，体力活动）、体重减轻和6个月时生活质量提高 与随机分配到对照组的患者相比的随访结果（次要结局） 3.评估可能影响EMBER实施的因素。初步实施结果将是 通过RE-AIM 4（范围、有效性、实施）和普罗克特等人5的实施进行评估 成果框架（可接受性、适当性、成本、忠实性）。（执行成果） 在退伍军人中进行的随机双中心混合型1型重复性试验 VA中肥胖患者的护理（N=470）。受试者将被随机分配至EMBER或对照组 包括可用的体重管理程序的列表。主要结果是任何体重 基线后2个月的管理参与。目标1和2将使用自我报告和管理数据， 评估干预结果。目标3将使用患者数据和研究人员的信息。 方法学： 实施/后续步骤：如果有效，我们将使用目标3建议的实施策略，以确保 退伍军人接收灰烬。我们将在混合型2试验中测试这些策略，以了解EMBER的 在真实的世界背景下的有效性以及传播和执行应急基金和 类似的干预措施。