Lifestyle Intervention vs. Metformin for Postpartum Weight Loss after Gestational Diabetes

This study is looking at whether a lifestyle intervention or the medication Metformin is more effective for weight loss in mothers who recently had gestational diabetes (diabetes during pregnancy). You could be eligible if you are a woman between 18 and 45 years old, and are 8 weeks to 12 months postpartum (after giving birth) from a pregnancy complicated by gestational diabetes. The study aims to see if either approach helps with weight loss over 6 months. Researchers will compare participants who receive Metformin Hcl 850Mg Tab to those who receive a Lifestyle Intervention or an Enhanced Lifestyle Intervention. The study plans to enroll 60 participants, but its current status is unclear.

Study design
This is an interventional study comparing different treatments, with a planned enrollment of 60 participants. It is not specified if participants will be randomly assigned to a treatment group.
What's involved
You would complete online forms and questionnaires, attend an in-person visit for blood tests and to receive a scale and activity tracker. You would also participate in weekly or bi-weekly Zoom sessions for 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to measure weight change at 6 months, indicating participants will be followed for at least that duration.

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NCT06948825

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

Recruiting
PHASE2Ages 18–45InterventionalPrevention
George Washington University
~60 participants
Updated 2026-01-13 on ClinicalTrials.gov
What's tested:Metformin Hcl 850Mg TabLifestyle InterventionEnhanced Lifestyle Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean weight change at 6 months
Measured over 6 months
Weight Loss
Gestational Diabetes Mellitus in Pregnancy
Postpartum Care
1 sites across 1 states
District of Columbia1
  • Wanda Nicholson, MD · PRINCIPAL_INVESTIGATOR · The George Washington University

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Eligibility criteria

Inclusion

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

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.
  • Mean weight change at 6 months6 months

    Weight in kg.