Power-Up: An Effectiveness Trial of the Diabetes Prevention Program Tailored for Black and Latino Men

摘要 一个基于诊所的翻译糖尿病预防计划（DPP）量身定制的黑人和拉丁美洲男子有潜力 解决DPP实施的局限性，减少男性糖尿病差异。拟定研究 旨在1）评估Power-Up与标准护理National DPP（NDPP）对以下人群体重减轻百分比的影响： 有糖尿病风险的种族/少数民族男性; 2）比较有糖尿病风险的种族/少数民族男性的参与情况， 糖尿病患者在Power-Up与标准护理NDPP中的差异;以及3）评估范围、有效性、采用、实施和 使用RE-AIM框架的上电成本。我们假设随机分配到Power-Up组的男性 第16周和第1年时的体重减轻（相对于基线的体重减轻%）显著大于随机分配至 标准护理，混合性别NDPP组。随机分配到Power-Up的男性也会有更大的参与度 费率（即，参加至少4次会议）和保留率（即，参加9个或更多的会议）比随机分配到 标准护理NDPP。使用大型学术医疗中心的电子健康记录（EHR）系统和网络 在整个纽约市的中小型独立初级保健实践中，我们将确定黑人和拉丁美洲男子 符合NDPP的BMI和A1 c资格要求。我们希望通过我们的健康招募450名参与者 系统合作伙伴。男性将以1：1的比例随机分配至增强干预组或标准NDPP组 在他们的诊所符合现行CDC标准和我们卫生系统合作伙伴的现行NDPP做法， 在这两种情况下，教练都将为错过现场训练的男子提供电话补课。的 主要结果将是在基线、大约16周（治疗结束时）测量的12个月内的体重减轻百分比。 核心会话）和12个月（维护会话结束）。研究收集的体重将是主要结局 在第一次通电或NDPP会议上由教练测量（或在会议不进行时由研究工作人员或临床研究中心测量） 出席）。样本量为450名男性，标准差为4.7个百分点， 组内（程序组内）相关性为0.05，我们将有98.2%的把握度检测到2.5个百分点 在0.05的显著性水平下，干预组之间的差异。这个样本量也会给我们80%的把握度 在敬业度上有13.8个百分点的差异，在保留率上有16.4个百分点的差异。 与RE-AIM评价相关的三级结局包括通过经验证的自我评估收集的定量和定性数据。 通过电话调查，EHR数据提取和定性访谈管理的报告问卷， 个人和焦点小组。我们的评估将回答对医疗保健系统和NDPP最重要的问题 提供者和我们与各种医疗保健系统的合作伙伴关系将使我们能够广泛传播干预措施， 证明有效。

Abstract A clinic-based translation of the Diabetes Prevention Program (DPP) tailored to Black and Latino men has the potential to address prior limitations of DPP implementation and reduce diabetes disparities among men. The proposed study is designed to 1) Assess the effect of Power-Up vs. standard care National DPP (NDPP) on percent weight loss among racial/ethnic minority men at risk for diabetes; 2) Compare engagement of racial/ethnic minority men at risk for diabetes in Power-Up vs. standard care NDPP; and 3) Evaluate the Reach, Effectiveness, Adoption, Implementation, and Costs of Power-Up using the RE-AIM framework. We hypothesize that men randomized to Power-Up will achieve significantly greater weight loss (% weight loss from baseline) at 16-weeks and 1-year than men randomized to the standard care, mixed-gender NDPP group. Men randomized to Power-Up will also have significantly greater engagement rates (i.e., attend at least 4 sessions) and retention rates (i.e., attend 9 or more sessions) than men randomized to the standard care NDPP. Using the electronic health record (EHR) systems of a large academic medical center and a network of small to medium independent primary care practices throughout New York City, we will identify Black and Latino men that meet the BMI and A1c eligibility requirements for NDPP. We expect to enroll 450 participants through our health system partners. Men will be randomized 1:1 to either the Power-Up intervention arm or referred to the standard NDPP at their clinic site. Consistent with current CDC standards and current NDPP practices of our health system partners, telephone make-up sessions will be offered by coaches in both conditions to men who miss in-person sessions. The primary outcome will be percent weight loss over 12 months, measured at baseline, approximately 16 weeks (end of core sessions), and 12 months (end of maintenance sessions). Study-collected weight will be the primary outcome measured at the first Power-Up or NDPP session by coaches (or from study staff or clinic sites when sessions are not attended). With a sample size of 450 men, a standard deviation of 4.7 percentage points in percent weight loss, and an intraclass (intra program group) correlation of 0.05 we would have 98.2% power to detect a 2.5 percentage point difference between the intervention arms at the 0.05 significance level. This sample size would also give us 80% power to detect a 13.8 percentage point difference in engagement, and a 16.4 percentage point difference in retention. Tertiary outcomes related to the RE-AIM evaluation include quantitative and qualitative data collected via validated self- report questionnaires administered via telephone survey, EHR-data extraction, and qualitative interviewing of individuals and focus groups. Our evaluation will answer questions most important to healthcare systems and NDPP providers and our partnerships with diverse healthcare systems will allow us to disseminate the intervention broadly, if proven effective.