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

摘要 为黑人和拉丁裔男性量身定做的糖尿病预防计划(DPP)的临床翻译具有潜力 以解决之前实施DPP的局限性，减少男性之间的糖尿病差距。建议的研究是 旨在1)评估通电与标准护理国家DPP(NDPP)对以下人群体重减轻百分比的影响 种族/少数民族男性患糖尿病的风险；2)比较种族/少数民族男性患糖尿病风险的参与度 糖尿病在加电与标准护理NDPP中的对比；以及3)评估覆盖范围、有效性、采用、实施和 使用RE-AIM框架的通电成本。我们假设，随机选择通电的男性将实现 在16周和1年内，体重下降(从基线开始的体重下降百分比)显著高于随机接受 标准护理，混合性别NDPP组。随机选择通电的男性也会有更大的参与度 与随机参加的男性相比，男性的保留率(即至少参加4次)和保留率(即参加9次或更多) 标准护理NDPP。使用大型学术医疗中心和网络的电子健康记录(EHR)系统 在整个纽约市的中小型独立初级保健机构中，我们将识别黑人和拉丁裔男性 符合NDPP的BMI和A1c资格要求。我们预计将通过我们的健康计划招募450名参与者 系统合作伙伴。男性将被1：1随机分配到加电干预臂或参考标准NDPP 在他们的诊所现场。与我们卫生系统合作伙伴当前的CDC标准和NDPP实践相一致， 在这两种情况下，教练都会为缺席面对面训练的男性提供电话化妆课程。这个 主要结果将是在12个月内体重减轻的百分比，以基线衡量，大约16周(结束 核心会议)和12个月(维护会议结束)。研究收集的体重将是主要结果 在第一次加电或NDPP课程时由教练测量(如果课程不是，则从研究人员或诊所现场测量 出席者)。样本量为450名男性，体重减轻百分比的标准偏差为4.7个百分点， 组内(计划内)相关性为0.05，我们将有98.2%的能力检测到2.5个百分点 干预组间差异达到0.05显著水平。这个样品的大小也会给我们80%的动力 发现参与度差异13.8个百分点，保留率差异16.4个百分点。 与RE-AIM评估相关的第三级结果包括通过有效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对 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 提供者和我们与不同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，如果 事实证明是有效的。

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.