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

Power-Up：针对黑人和拉丁裔男性的糖尿病预防计划的有效性试验

基本信息

批准号：
10908006
负责人：
Earle C Chambers
金额：
$ 6.48万
依托单位：
ALBERT EINSTEIN COLLEGE OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-16 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10908006
关键词：
Academic Medical Centers Address Adoption Affect Black race Blood Pressure Body Weight decreased Body mass index Cessation of life Clinic Clinical Data Collaborations Data Diabetes Mellitus Diabetes prevention Disadvantaged Disparity Effectiveness Electronic Health Record Eligibility Determination Enrollment Epidemic Evaluation Exposure to Failure Focus Groups Funding Future Gender Glycosylated hemoglobin A Goals Health Health Promotion Health behavior Health system Healthcare Systems Individual Intervention Interview Latino Maintenance Measures Mental Health Methods Minority Men National Institute of Diabetes and Digestive and Kidney Diseases New York City Non-Insulin-Dependent Diabetes Mellitus Outcome Outcome Measure Participant Patient Outcomes Assessments Patient Self-Report Persons Physicians Pilot Projects Population Prediabetes syndrome Prevalence Primary Care Provider Psychosocial Factor Questionnaires Randomized Randomized, Controlled Trials Reach, Effectiveness, Adoption, Implementation, and Maintenance Research Personnel Sample Size Sampling Site Surveys Telephone Testing Translations Urban Community Weight Woman Work cost design diabetes prevention program diabetes risk disability effectiveness evaluation effectiveness trial electronic health record system ethnic disparity ethnic minority gender disparity health care settings men men of color neighborhood disadvantage outreach personalized approach preference primary care practice primary care setting primary outcome program costs programs racial disparity racial minority recruit retention rate secondary outcome standard care treatment arm

项目摘要

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.

抽象的针对黑人和拉丁裔男人量身定制的糖尿病预防计划（DPP）的基于诊所的翻译具有潜力解决DPP实施的先前局限性并减少男性的糖尿病差异。拟议的研究是设计为1）评估加电与标准护理国家DPP（NDPP）对体重百分比减轻百分比的影响种族/族裔少数民族有糖尿病风险； 2）比较有风险的种族/族裔少数民族的参与加电与标准护理NDPP中的糖尿病； 3）评估覆盖范围，有效性，采用，实施和使用RE-AIM框架的加电成本。我们假设男人随机加强力量将实现在16周和1年的男性中，体重减轻（基线减肥％减轻％减肥）明显更大标准护理，混合性别NDPP组。随机加电的男性也将具有更大的参与度比率（即至少参加4次会议）和保留率（即参加9次或更多会议）比随机的男人标准护理NDPP。使用大型学术医学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实践中，我们将确定黑人和拉丁美洲人符合NDPP的BMI和A1C资格要求。我们希望通过我们的健康注册450名参与者系统合作伙伴。男性将被随机分配给加电干预臂或转介给标准NDPP 在他们的诊所地点。与当前的CDC标准和我们卫生系统合作伙伴的当前NDPP实践一致，在这两种情况下，教练都会为错过面对面会议的男人提供电话彩妆课程。这主要结果将是12个月内的体重减轻百分比，在基线时测量，约16周（结束核心会议）和12个月（维护结束）。研究的体重将是主要结果在教练的第一次加电或NDPP会议上测量（或从学习人员或诊所地点时，参加）。样本量为450人，体重减轻百分比的标准偏差为4.7个百分点，一个内部（Intra Intra Intra Group）相关性为0.05，我们将拥有98.2％的功率来检测2.5个百分点干预臂在0.05显着性水平上的差异。此样本量也将为我们提供80％的功率检测参与度的13.8个百分点差异，保留率差异为16.4个百分点。与重新评估有关的第三级结果包括通过验证的自我收集的定量和定性数据报告通过电话调查，EHR-DATA提取和定性访谈的报告调查表个人和焦点小组。我们的评估将回答对医疗系统和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大致传播干预措施，如果被证明有效。