Actively Recruiting
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Led by George Washington University · Updated on 2026-01-13
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
G
George Washington University
Lead Sponsor
U
University of North Carolina
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the effectiveness of a 6-month lifestyle intervention compared to Metformin in postpartum women who have delivered a singleton, live born infant within the last 12 weeks to 1 year and had a pregnancy complicated by gestational diabetes. The main question this study aims to answer is: Is a Lifestyle Intervention or Metformin more effective for weight loss in postpartum women with recent gestational diabetes? Researchers will compare a 6-month Lifestyle Intervention and Metformin to see if either intervention is more effective in achieving weight loss and improving health outcomes. Participants will: * Attend an in-person baseline visit to receive a Bluetooth-enabled scale and Fitbit, have blood drawn for testing, and have their height, weight, and blood pressure measured. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length. * Track diet, physical activity, and weight using the Fitbit and Looseit! apps. * Attend weekly online group sessions for the first 4 weeks, then biweekly sessions. * If not meeting weight loss goals, be randomized to either Enhanced Lifestyle Intervention or Metformin arms of the study. * If randomized to Metformin, participants will attend one in-person meeting with the study provider, get blood drawn for testing, and undergo a urine pregnancy test before starting the medication. * Continue with biweekly group sessions or have regular check-in calls. * If randomized to the Enhanced Lifestyle Intervention, participants will get a free Instacart membership, a 1:1 session with the study health counselor focused on meal planning and free grocery delivery once a week for the remainder of the study. * Participants will meet every other week via Zoom with the health counselor and other participants in the enhanced lifestyle arm. * At the end of the 6 months, all participants will come for an in-person visit to get blood drawn for testing. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.
CONDITIONS
Official Title
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mothers between 8 weeks and 12 months postpartum from a pregnancy complicated by gestational diabetes mellitus
- Body mass index (BMI) between 25 and 45 kg/m2
- Singleton delivery
- Must have a working cell phone, be willing to accept email or text messages, attend Zoom calls, and be willing to possibly take Metformin medication if randomized
You will not qualify if you...
- Currently pregnant or planning pregnancy within the next 6 months
- Participation in any other weight loss program or taking weight loss medication
- Normal or underweight BMI (less than 25 kg/m2)
- Multiple pregnancy (twins or triplets)
- Diagnosis of type 1 or type 2 diabetes, cancer, advanced kidney disease, severe heart or lung disease, serious psychiatric illness, substance abuse, or AIDS
- Infant with significant medical conditions such as congenital heart disease, kidney or liver problems
AI-Screening
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Trial Site Locations
Total: 1 location
1
Milken Institute School of Public Health - The George Washington University
Washington D.C., District of Columbia, United States, 20052
Actively Recruiting
Research Team
J
Jennifer R Gomez Berrospi, MPH
CONTACT
W
Wanda Nicholson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
3
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