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Enhanced enrollment in the National Diabetes Prevention Program for the underserved: a randomized control trial

Award Number: R01DK119478
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Summary Type 2 diabetes affects 9.4% of US adults with higher rates among racial/ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among Hispanic, non-Hispanic black, and low-income non-Hispanic white participants. Strategies to improve NDPP engagement and weight loss are needed urgently, especially for these subgroups. Pilot results of the Pre- NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a non-randomized cohort study among 1,140 racially diverse, predominately low-income participants. Outcomes of 75 Pre-NDPP participants who enrolled in the NDPP were compared to 1,065 prior participants using ANCOVA and multivariable logistic regression. Pre-session participants stayed in the NDPP 99.8 days longer (p<.001) and attended 14.3% more sessions (p<.001) on average than those without a pre- session. Pre-session participants lost 2.0% more weight (p<.001) and were 3.5 times more likely to achieve the 5% weight loss target (p<.001). Sensitivity analyses were consistent. Findings suggest pre-sessions may be a promising and pragmatic strategy to improve NDPP effectiveness and mitigate disparities in program outcomes, but a randomized controlled trial (RCT) is needed to determine whether Pre-NDPP reliably improves NDPP outcomes. The purpose of this study is to 1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive Pre-NDPP vs. direct enrollment into the NDPP (usual care), 2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race/ethnicity and income level), and 3) evaluate implementation factors, including cost and projected return on investment. The long-term goal is to disseminate a scalable, evidence-based strategy to improve success of the NDPP and reduce disparities in NDPP effectiveness. If found to be effective, Pre-NDPP can be disseminated to all NDPP providers, including more than 1,700 NDPP sites, and may be supported by current NDPP payers such as Medicare, commercial insurers, and employer groups. Thus, this approach has a high potential to impact the burden of type 2 diabetes and related health disparities across the country.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	DENVER HEALTH AND HOSPITAL AUTHORITY	777 BANNOCK ST	DENVER	CO	80204	DENVER	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	2/1/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $479,778 )
2023	2023	DENVER HEALTH AND HOSPITALS AUTHORITY	777 BANNOCK ST	DENVER	CO	80204	DENVER	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	4/4/2023	NON-COMPETING CONTINUATION	$479,778
														Subtotal = $479,778

Issue Date FY: 2022 ( Subtotal = $555,201 )
2022	2022	DENVER HEALTH AND HOSPITALS AUTHORITY	777 BANNOCK ST	DENVER	CO	80204	DENVER	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	4/1/2022	NON-COMPETING CONTINUATION	$555,201
														Subtotal = $555,201

Issue Date FY: 2021 ( Subtotal = $597,511 )
2021	2021	DENVER HEALTH AND HOSPITALS AUTHORITY	777 BANNOCK ST	DENVER	CO	80204	DENVER	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	3/30/2021	NON-COMPETING CONTINUATION	$597,511
														Subtotal = $597,511

Issue Date FY: 2020 ( Subtotal = $589,437 )
2020	2020	DENVER HEALTH AND HOSPITALS AUTHORITY	777 BANNOCK ST	DENVER	CO	80204	DENVER	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	3/30/2020	NON-COMPETING CONTINUATION	$589,437
2020	2019	DENVER HEALTH AND HOSPITALS AUTHORITY	777 BANNOCK ST	DENVER	CO	80204	DENVER	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	1/7/2020	NEW	$0
														Subtotal = $589,437

Issue Date FY: 2019 ( Subtotal = $585,437 )
2019	2019	DENVER HEALTH AND HOSPITALS AUTHORITY	777 BANNOCK ST	DENVER	CO	80204	DENVER	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	8/26/2019	NEW	$0
2019	2019	DENVER HEALTH AND HOSPITALS AUTHORITY	777 BANNOCK ST	DENVER	CO	80204	DENVER	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	4/1/2019	NEW	$585,437
														Subtotal = $585,437

Grand Total All Awards = $2,807,364

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Enhanced enrollment in the National Diabetes Prevention Program for the underserved: a randomized control trial

Award Number: R01DK119478

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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