Introduction and Objective: Women with overweight/obesity, prediabetes and a history of gestational diabetes mellitus (GDM) face a “preference-sensitive” decision for T2DM prevention since both intensive lifestyle intervention/DPP and metformin lower risk of incident T2DM. Methods: In the Gestational diabetes Risk Attenuation for New Diabetes (GRAND) study, we conducted a two-site RCT of SDM intervention vs active control. Pharmacists and nurses delivered the SDM intervention using a decision aid presenting Intensive Lifestyle Intervention/Diabetes Prevention Program (ILI/DPP) and/or metformin as evidence-based, prevention options. Active control participants reviewed print materials with trained research staff. Our primary outcome was ≥5% weight loss over 12 months follow-up. Secondary outcomes included uptake of DPP and/or metformin or dietary and physical activity measures. Multivariate analyses controlled for site and family history of diabetes. Results: Among 247 participants (n=114 intervention, n=133 active control), we observed a nonsignificant trend toward ≥5% weight loss among intervention vs. active control arm (OR 1.76, 0.94-3.30, p=0.08) at 12-months follow-up. Intervention participants were more likely to initiate the DPP (OR 2.95, 1.47-5.89, p=0.002) and/or metformin (OR 8.46, 3.58-19.96, p0.0001) than active control participants. Intervention participants reported eating ultra-processed foods less frequently than active control participants (OR 0.53, 0.32-0.88, p=0.01). Conclusion: Our RCT of a shared decision-making intervention for T2DM prevention for women with overweight/obesity, prediabetes and a history of GDM showed a non-significant trend toward achieving ≥5% weight. However, SDM increased the likelihood of participation in evidence-based prevention options which hold promise to reduce diabetes risk. Disclosure O. Duru: Consultant; Current; Boehringer Ingelheim International GmbH. T. Tibbe: None. L. Wisk: None. C.S. Han: None. A. Moss: None. F. Cheng: None. J. Chon: None. J. Krong: None. S. Liu: None. A. Malone: None. R.P. Maranon: None. C. Mangione: None. K.C. Norris: Consultant; Current; Atlantis Health Care Inc. J. Page: None. S.C. Thomas: Employee; Current; PocketRN. T. Moin: None. Funding NIH/NIDDK (R01DK127733)
DURU et al. (Fri,) studied this question.