Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes

Launched by GEORGE WASHINGTON UNIVERSITY · Apr 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a 6-month program focused on lifestyle changes (like diet and exercise) is more effective for weight loss compared to the medication Metformin in mothers who recently had gestational diabetes. The trial is specifically for women who are between 8 weeks and 12 months postpartum and have a body mass index (BMI) between 25 and 45. Participants in the study will receive support through weekly online group sessions, tracking their diet and activity with a Fitbit and an app, and may be randomly assigned to either the lifestyle program or to take Metformin if they are not meeting their weight loss goals.

To participate, women must have delivered a single baby and should not be planning to get pregnant soon or have certain health conditions, such as type 1 or type 2 diabetes. Each participant will attend an initial visit for health checks and will return for follow-ups, including measuring their baby's growth. This study aims to discover which approach—lifestyle changes or medication—better helps women manage their weight and health after experiencing gestational diabetes.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Mothers between 8 weeks and 12 months postpartum from a pregnancy complicated by GDM will be recruited. The research team will begin recruiting women who are at least 8 weeks postpartum to provide time to describe the study and answer any questions. Mothers who want to participate will be enrolled in the study between 12 weeks and 12 months postpartum.
• • BMI of 25 kg/m2 to 45 kg/m2
• • Singleton delivery
• • Participants must also have a working cell phone, be willing to accept email or text messages attend Zoom calls, and be willing to be potentially randomized to drug therapy with Metformin.
• Exclusion Criteria:
• • Pregnant or planned pregnancy within the next 6 months.
• • Participation in any other weight loss program or taking weight loss medication.
• • Normal or underweight BMI (BMI \< 24.9 kg/m2)
• • Multi-fetal (twins or triplets) gestation
• • Women with type 1 or type 2 diabetes, malignancy, other serious co-morbidities (advanced kidney disease, NYHA class 3-4 CHF, advanced COPD), schizophrenia or other major psychiatric disease, and substance abuse or AIDS.
• • Women whose infants have significant medical conditions, such as congenital heart disease, renal impairment, or hepatic impairment.