
GoodMomS 2 Study
Overview
GooDMomS2- A Bio-Behavioral Study
Of the 4 million women who give birth each year in the U.S., 7-14% (~240,000) will have been diagnosed with gestational diabetes mellitus (also known as GDM), depending on race/ethnicity, geography, and diagnostic thresholds. About 30% of those diagnosed will have GDM in the next pregnancy, and over time, mothers with GDM are at high risk for type 2 diabetes and cardiovascular disease (CVD) with hazard ratios of 5-10 for diabetes and 3-4 for CVD. Sustainable weight loss after delivery is a key factor for preventing diabetes and CVD. For every 1 kg of weight loss, there is a 16% reduction in diabetes risk and a 2 mmHg decrease in blood pressure.
In GooDMomS2, we expanded the scope of interventions. We propose an adaptive trial design among 60 participants to assess the effects of a DPP-based lifestyle intervention (LI) compared to an Enhanced Lifestyle intervention (ELI) that includes meal planning, compared to Metformin 750 mg twice daily.
Visit the GooDMomS website for more details.
Outcomes
- Mean weight change at 6 months (primary)
- Improvement in physical activity score
- Physiological outcomes (change in blood pressure, A1c, lipids)
- Wellness (quality of life, depression score) and lifestyle behaviors (diet quality, breastfeeding)
- Adherence to Metformin treatment
- Adverse events in either study arm.
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