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A Shared Decision Making Intervention for Diabetes Prevention in Women with a History of Gestational Diabetes Mellitus.

Award Number: R01DK127733
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/ABSTRACT Women with a history of gestational diabetes mellitus (GDM) are at high risk of developing type 2 diabetes (T2DM). Evidence from the Diabetes Prevention Program indicates that lifestyle change and metformin use in this population are clinically equivalent, each reducing the incidence of T2DM by approximately 50% among women with a GDM history. These women face a preference-sensitive decision between the evidence-based alternatives. Shared decision making (SDM) is an attractive approach in this situation, using a decision aid to make the decision explicit, describe the available options with equipoise, elicit patient preferences, and help patients make an informed decision that is right for them. To our knowledge, there are no existing studies evaluating SDM for diabetes prevention among women with a history of GDM. Our team has extensive experience with a team-based SDM approach for diabetes prevention, and our prior work showed that this approach leads to increased uptake of an evidence-based diabetes prevention strategy (lifestyle change, metformin or both) as well as sustained weight loss at 12-month follow-up in a broader population with prediabetes. We have also completed a pilot test of SDM among 33 women with a GDM history, demonstrating feasibility and acceptability. In this proposal, we aim to evaluate SDM for diabetes prevention among women with a history of GDM and prediabetes within two health systems (UCLA and Intermountain). Pharmacists will implement the intervention at UCLA, and clinic care managers will implement the intervention at Intermountain. Our Specific Aims are as follows: To test the effectiveness of an RCT evaluating SDM for diabetes prevention on 1) weight loss among overweight/obese women with a history of GDM and hemoglobin A1c between 5.7-6.4%, 2) uptake of lifestyle change and/or metformin use, patient- reported outcomes (physical activity, eating patterns, patient activation, health-related quality of life), annual follow-up screening for progression to T2DM, and rates of GDM in a subsequent pregnancy (exploratory outcome), and 3) to evaluate the incremental cost of program implementation per woman with a history of GDM and hemoglobin A1c between 5.7-6.4% who successfully initiates lifestyle change and/or metformin. Our application presents a unique opportunity to implement a rigorous project addressing a critical area of unmet need in diabetes prevention for women with history of GDM, leveraging our health system infrastructure and our collaborative, multidisciplinary team with a strong record of accomplishment in diabetes prevention. This work will provide pragmatic, effective and sustainable approaches to increase evidence-based diabetes prevention strategies for women with a history of GDM that can be readily adopted in other health systems.


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: 2025 ( Subtotal = $490,857 )
2025	2025	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	11/25/2024	NON-COMPETING CONTINUATION	$490,857
														Subtotal = $490,857

Issue Date FY: 2024 ( Subtotal = $530,770 )
2024	2024	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	002	4	5/6/2024	NON-COMPETING CONTINUATION	$33,170
2024	2024	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	11/28/2023	NON-COMPETING CONTINUATION	$497,600
2024	2023	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	12/5/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $530,770

Issue Date FY: 2023 ( Subtotal = $756,961 )
2023	2023	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	7/29/2023	SUPPLEMENT FOR EXPANSION	$193,004
2023	2023	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	1/20/2023	NON-COMPETING CONTINUATION	$563,957
														Subtotal = $756,961

Issue Date FY: 2022 ( Subtotal = $575,294 )
2022	2022	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	4/7/2022	NON-COMPETING CONTINUATION	$57,528
2022	2022	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	11/5/2021	NON-COMPETING CONTINUATION	$517,766
														Subtotal = $575,294

Issue Date FY: 2021 ( Subtotal = $589,875 )
2021	2021	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90095	LOS ANGELES	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	2/15/2021	NEW	$589,875
														Subtotal = $589,875

Grand Total All Awards = $2,943,757

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A Shared Decision Making Intervention for Diabetes Prevention in Women with a History of Gestational Diabetes Mellitus.

Award Number: R01DK127733

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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