Project Details
Description
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.
Status | Active |
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Effective start/end date | 9/16/19 → 8/31/24 |
Funding
- National Institute of Diabetes and Digestive and Kidney Diseases: $665,667.00
- National Institute of Diabetes and Digestive and Kidney Diseases: $733,278.00
- National Institute of Diabetes and Digestive and Kidney Diseases: $621,196.00
- National Institute of Diabetes and Digestive and Kidney Diseases: $635,845.00
- National Institute of Diabetes and Digestive and Kidney Diseases: $64,781.00
- National Institute of Diabetes and Digestive and Kidney Diseases: $32,389.00
- National Institute of Diabetes and Digestive and Kidney Diseases: $139,999.00
- National Institute of Diabetes and Digestive and Kidney Diseases: $741,084.00
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