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Madievsky R, Vu A, Cheng F, Chon J, Turk N, Krueger A, Krong J, Maranon R, Liu S, Han CS, Norris KC, Mangione C, Page J, Thomas S, Duru OK, Moin T. A randomized controlled trial of a shared decision making intervention for diabetes prevention for women with a history of gestational diabetes mellitus: The Gestational diabetes Risk Attenuation for New Diabetes (GRAND study). Contemporary clinical trials. 2023 Jan 1; 124:107007.
BACKGROUND: Gestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Metformin and lifestyle change through a Diabetes Prevention Program (DPP) are equally effective in preventing diabetes in patients with a GDM history, so women can choose a strategy based on their preferences. This study aims to test whether shared decision making (SDM) can help women with a history of GDM increase adoption of evidence-based strategies and lose weight to lower their risk of incident diabetes in real-world settings. METHODS: This pragmatic randomized controlled trial (RCT) will test the effectiveness of SDM for diabetes prevention among 310 overweight/obese women with a history of GDM and prediabetes from two large health care systems (n = 155 from UCLA Health and n = 155 from Intermountain Healthcare). The primary outcome is the proportion of participants who lose = 5% body weight at 12 months. Secondary outcomes include uptake of DPP and/or metformin and other patient-reported outcomes such as patient activation and health-related quality of life. Rates of GDM in a subsequent pregnancy will be an exploratory outcome. A descriptive analysis of costs related to SDM implementation will also be conducted. CONCLUSION: This is the first RCT to examine the effectiveness of SDM on weight loss, lifestyle change and/or metformin use, and other patient-reported outcomes in participants with a GDM history at risk of developing diabetes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03766256. Registered on 6 December 2018.