Lifestyle program versus metformin for postpartum weight loss after gestational diabetes
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
PHASE2 · George Washington University · NCT06948825
This trial tests whether a 6-month online lifestyle program or taking metformin helps women who had gestational diabetes lose weight in the first year after delivery.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | George Washington University (other) |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06948825 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial compares a Diabetes Prevention Program–based 6-month lifestyle intervention, an enhanced lifestyle arm, and metformin in women 12 weeks to 12 months postpartum after a pregnancy complicated by gestational diabetes. Participants receive a Bluetooth scale and Fitbit, attend regular online group sessions led by a trained health counselor, and submit diet, activity, and weight data while researchers collect baseline blood tests (HbA1c and lipids) and vital signs. One arm receives metformin 850 mg tablets while the other arms receive standard or enhanced lifestyle support; outcomes include weight change and cardiometabolic measures collected over the study period. Study staff review remote monitoring data and provide feedback by email or text to support behavior change.
Who should consider this trial
Good fit: Mothers between about 12 weeks and 12 months postpartum after a singleton pregnancy complicated by gestational diabetes with BMI 25–45 kg/m2 who have a working cell phone and can join Zoom sessions are ideal candidates.
Not a fit: Women who are pregnant or planning pregnancy within six months, have type 1 or type 2 diabetes, are already in another weight-loss program, or have serious comorbidities are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the intervention could help postpartum women achieve greater weight loss and reduce future diabetes risk through a scalable lifestyle program or metformin.
How similar studies have performed: Prior DPP-style lifestyle programs and metformin have both reduced diabetes risk in other populations, but direct head-to-head comparisons focused on recent postpartum women are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Washington D.C., District of Columbia
- Milken Institute School of Public Health - The George Washington University — Washington D.C., District of Columbia, United States (RECRUITING)
Study contacts
- Principal investigator: Wanda Nicholson, MD — The George Washington University
- Study coordinator: Jennifer R Gomez Berrospi, MPH
- Email: Jengomez291@gwu.edu
- Phone: 202-994-2582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Weight Loss, Gestational Diabetes Mellitus in Pregnancy, Postpartum Care, diabetes prevention, gestational diabetes, lifestyle intervention