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：
10475221
负责人：
Earle C Chambers
金额：
$ 74.11万
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/10475221
关键词：
Academic Medical Centers Address Adoption Affect Black race Blood Pressure Body Weight decreased Body mass index Centers for Disease Control and Prevention (U.S.)Cessation of life Clinic Clinical Data Collaborations Communities Data Diabetes Mellitus Diabetes prevention Disadvantaged 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 Health Care Provider Psychosocial Factor Questionnaires Randomized Randomized Controlled Trials Reach Effectiveness Adoption Implementation and Maintenance Research Personnel Sample Size Sampling Site Surveys System Telephone Testing Translations Urban Community Weight Woman Work base design diabetes prevention program diabetes risk disability effectiveness evaluation effectiveness trial ethnic minority gender disparity health care settings implementation cost men men of color outreach personalized approach preference primary care setting primary outcome program costs programs racial and ethnic racial and ethnic disparities 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性量身定制的糖尿病预防计划 (DPP) 的临床翻译具有潜力解决 DPP 实施之前的局限性并减少男性之间的糖尿病差异。拟议的研究是旨在 1) 评估 Power-Up 与标准护理国家 DPP (NDPP) 对体重减轻百分比的影响有患糖尿病风险的种族/族裔男性； 2) 比较有风险的种族/族裔少数男性的参与度 Power-Up 与标准护理 NDPP 中的糖尿病； 3) 评估范围、有效性、采用、实施和使用 RE-AIM 框架的启动成本。我们假设随机接受 Power-Up 的男性将实现与随机分组的男性相比，第 16 周和第 1 年时的体重减轻（相对于基线的体重减轻百分比）显着增加标准护理，混合性别 NDPP 组。随机分配到 Power-Up 的男性也会有显着更高的参与度率（即参加至少 4 次课程）和保留率（即参加 9 次或更多课程）高于随机分配到该组的男性标准护理 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，我们将识别黑人和拉丁裔男性满足 NDPP 的 BMI 和 A1c 资格要求。我们预计通过我们的健康计划招募 450 名参与者系统合作伙伴。男性将按照 1:1 的比例随机分配到 Power-Up 干预组或转入标准 NDPP 在他们的诊所现场。符合当前 CDC 标准和我们卫生系统合作伙伴当前的 NDPP 实践，在这两种情况下，教练都会为错过现场训练的男子提供电话补课。这主要结果是 12 个月内体重减轻百分比，在基线时测量，大约 16 周（研究结束时）核心课程）和 12 个月（维护课程结束）。研究收集的体重将是主要结果由教练在第一次 Power-Up 或 NDPP 课程中进行测量（或者在课程不进行时由研究人员或诊所进行测量）参加）。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，类内（项目组内）相关性为 0.05，我们将有 98.2% 的功效检测到 2.5 个百分点干预组之间的差异达 0.05 显着性水平。这个样本量也将为我们提供 80% 的功效发现参与度差异 13.8 个百分点，保留度差异 16.4 个百分点。与 RE-AIM 评估相关的第三个结果包括通过经过验证的自我收集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进行报告调查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以及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，如果事实证明有效。