Testing the Efficacy of a Technology-Assisted Weight Management Intervention within Patient-Centered Medical Homes: The GEM (Goals for Eating and Moving) Study

项目摘要 美国预防服务工作组（USPSTF）建议初级保健提供者使用 5As框架（评估，建议，同意，协助，安排）为肥胖患者提供咨询。提供商 由于竞争性需求和低感知能力等障碍，经常不为患者提供咨询 这可能导致患者对有效的体重管理计划的关注度差。病人为本 医疗之家可以使用基于团队的护理来解决这些障碍， 管理计划，并为那些不参加的人提供体重管理服务。我们 开发并形成性评估了一种创新的、技术辅助的5As干预措施，以促进 减肥，行为改变，并增加密集课程的入学率（例如，MOVE！程序从 退伍军人事务部（VA）和糖尿病预防计划）。这次干预，被称为 GEM（饮食和移动目标），使用4个组件提供5A咨询-GEM在线工具， 健康教练咨询、初级保健小组简短咨询和后续电话辅导。GEM工具 是一个移动友好的软件程序，通过平板电脑在初级保健设置，以促进 由健康教练和初级保健人员提供咨询。我们的初步数据表明，创业板干预是 对患者和工作人员来说是可行的和可接受的，并有助于5A咨询。需要进行随机试验， 检查其对减肥和健康结果的影响。我们将进行一项随机分组对照试验 在2个城市健康中心：VA纽约港和Montefiore医疗集团（MMG）内的站点， 评估GEM干预措施与增强型孕产妇保健相比的有效性。我们将招募512名患者 来自16个初级保健团队（8个来自VA站点，8个来自MMG站点），每个团队有2个或更多的初级保健提供者。 符合条件的患者，体重指数≥30 kg/m2或>25 kg/m2，合并即将进行的主要 将通过邮件和电话进行预约。初级保健团队中的患者 随机分配到干预组的患者将接受GEM干预，对照组的患者将 获得更好的护理。主要结局将是1年干预结束时的体重减轻。 我们将使用RE-AIM评估框架来评估覆盖范围（入组的合格患者比例）， 有效性（体重减轻和其他相关结果），采用（初级保健团队的可接受性）， 实施（干预保真度）和维持（体重变化和计划的可持续性 随机化后12至24个月的组分）。

PROJECT SUMMARY The United States Preventive Services Task Force (USPSTF) recommends that primary care providers use the 5As framework (Assess, Advise, Agree, Assist, Arrange) to provide counseling to obese patients. Providers frequently do not counsel patients due to barriers such as competing demands and low perceived competency which may contribute to poor patient attendance to effective weight management programs. Patient-centered medical homes can use team-based care to address these barriers, increase attendance to intensive weight management programs, and provide weight management services to those who do not to attend. We developed and formatively evaluated an innovative, technology-assisted 5As-based intervention to promote weight loss, behavior change, and increase enrollment in intensive programs (e.g. the MOVE! program from the Veteran’s Affairs (VA) and the Diabetes Prevention Program) within medical homes. This intervention, called GEM (Goals for Eating and Moving), uses 4 components to deliver 5As counseling—the GEM online tool, health coach counseling, brief primary care team counseling, and follow-up telephone coaching. The GEM tool is a mobile-friendly software program delivered via tablet computers in the primary care setting to facilitate counseling by a health coach and primary care staff. Our preliminary data suggest that the GEM intervention is feasible and acceptable to patients and staff and facilitates 5As counseling. A randomized trial is needed to examine its impact on weight loss and health outcomes. We will conduct a cluster-randomized controlled trial at 2 urban health centers: the VA New York Harbor and at sites within the Montefiore Medical Group (MMG) to assess the efficacy of the GEM intervention compared to Enhanced Usual Care. We will recruit 512 patients from 16 primary care teams (8 from VA sites, 8 from MMG sites), each with 2 or more primary care providers. Eligible patients with a Body Mass Index of ≥30 kg/m2 or >25 kg/m2 and comorbidities with upcoming primary care appointments will be recruited via mail with follow up telephone calls. Patients within primary care teams randomized to the intervention group will receive the GEM intervention and those in the control group will receive Enhanced Usual Care. The primary outcome will be weight loss at the end of the 1 year intervention. We will use the RE-AIM evaluation framework to assess the reach (proportion of eligible patients who enroll), efficacy (weight loss and other related outcomes), adoption (acceptability to primary care teams), implementation (intervention fidelity) and maintenance (sustainability of weight change and program components between 12 and 24 months post-randomization).