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Led by George Washington University · Updated on 2026-01-13
60
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying postpartum women who have had gestational diabetes during pregnancy to compare the effects of a 6-month lifestyle intervention versus Metformin for weight loss and health improvements. This Phase 2 clinical trial focuses on women who delivered a single baby within the last 12 weeks to one year and aims to find out which approach helps participants lose weight more effectively after pregnancy. The study starts with all participants joining a lifestyle program including weekly online group sessions for 4 weeks followed by biweekly sessions. Those who do not meet weight loss goals by weeks 4 or 6 may be randomly assigned to either an enhanced lifestyle intervention, which adds meal planning support and free grocery delivery, or a Metformin medication group. The Metformin group receives an in-person counseling session, lab testing, and takes Metformin tablets daily. Both groups continue their assigned interventions for a total of 6 months. Participants will attend baseline and end-of-study visits in person for measurements and blood tests, including tracking their infants growth. They will use Fitbit and a diet app to monitor activity and food intake throughout. Regular online group sessions, check-in calls, and questionnaires will assess progress, physical activity, blood pressure, blood sugar, lipids, quality of life, depression, breastfeeding, medication adherence, and infant growth during the study. The total participation lasts 6 months.
CONDITIONS
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
J
Jennifer R Gomez Berrospi, MPH
W
Wanda Nicholson, MD
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George Washington University
Lead Sponsor
University of North Carolina
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Enhanced Lifestyle Intervention (eLI) | Lifestyle Intervention (LI) | Metformin Arm (MI) | Standard Postpartum Care (Guideline-supported) |
|---|---|---|---|---|
| What it is | A behavioral program with virtual group sessions, personalized meal planning support, and grocery delivery for mothers who recently had gestational diabetes. | A standard behavioral program with virtual group sessions focused on weight loss and healthy lifestyle after gestational diabetes. | Prescription of metformin 850mg, taken orally twice daily with blood testing and virtual provider meetings. | Usual postpartum care after gestational diabetes, including lifestyle recommendations, screening for glucose abnormalities, and general support, without structured behavioral programs or routine drug therapy for weight loss or diabetes prevention. |
| Primary use | Designed to promote weight loss, encourage healthy lifestyle habits, and reduce risk of type 2 diabetes for postpartum women with prior GDM. | Intended to help postpartum women with prior GDM achieve weight loss and lower diabetes risk through behavior change. | Used as a medication to facilitate weight loss and reduce the risk of developing type 2 diabetes after gestational diabetes. | Supports gradual postpartum weight loss and ongoing glucose monitoring, aiming to prevent future diabetes through lifestyle counseling and routine care. |
| How it is given or performed | Virtual meetings every other week with health counselors, personalized meal-planning sessions, and free grocery delivery. | Weekly Zoom sessions transitioning to every other week for behavioral education and support. | Metformin tablets taken orally twice per day, with blood tests, urine pregnancy checks, and virtual provider consultations. | Periodic clinic visits for weight, glucose, and blood pressure checks, general advice on healthy diet and physical activity, and ongoing screening for abnormal glucose according to guidelines. |
| Evidence status | The program is being prospectively evaluated in a randomized trial; definitive results are not yet established. | Lifestyle interventions for weight loss and diabetes prevention have demonstrated benefit in postpartum and pre-diabetes populations in published studies, but intensive structured programs in this population remain under continued study. | Metformin has been shown in randomized studies to reduce diabetes risk and facilitate weight loss in populations at increased risk, but its routine use for postpartum weight management is not currently guideline-supported. | Guideline-supported postpartum care advises lifestyle change and routine screening; large observational studies confirm gradual weight loss and ongoing diabetes risk reduction but lack intensive intervention-level results. |
| Important limitations | The approach requires frequent virtual meetings, access to digital counseling, grocery delivery, and personalized support, which may not be available outside the study setting. Efficacy still awaits prospective trial results. | Behavioral interventions rely heavily on participant engagement; virtual sessions may not be effective for all, and real-world implementation outside clinical trials is often limited. | Metformin is not currently a guideline-supported routine medication for postpartum weight loss in mothers with prior GDM; drug adherence, tolerability, and monitoring requirements may affect real-world uptake. | Usual postpartum care typically involves infrequent visits and general lifestyle advice, which may be insufficient for significant weight loss or sustained diabetes prevention without more intensive behavioral or medication interventions. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete online medical history and questionnaires. They attend an in-person visit to receive a digital scale and Fitbit, have blood drawn for lab tests, and infant measurements are taken.
1 visit (in-person)
Duration - 6 weeks
Participants begin weekly 45-minute online group sessions via Zoom for 4 weeks, then sessions become biweekly. Participants use Fitbit and digital scales to track progress. The goal is to achieve weight loss targets at 4 and 6 weeks.
Weekly group sessions for 4 weeks, then biweekly sessions until week 6
Duration - Up to 5.5 months
Participants who reach weight loss goals continue with the Lifestyle Intervention biweekly for a total of 6 months. Those who do not reach goals are randomized to either Enhanced Lifestyle Intervention or Metformin treatment.
Biweekly group sessions for Enhanced Lifestyle Intervention; regular follow-up calls for Metformin group
Duration - Up to 5.5 months
Participants receive biweekly online group sessions including guidance on healthy meal planning and online grocery shopping with free delivery. Sessions last 45-60 minutes led by a health counselor.
Biweekly group sessions
Duration - 4.5 to 5 months
Participants have an in-person session to learn about Metformin and infant hypoglycemia risks, followed by lab tests. Metformin is taken orally with dosage escalation. Follow-up calls occur 1 week after start and then every 2 weeks to monitor side effects and adherence.
1 in-person session, then follow-up calls weekly at first and biweekly thereafter
Duration - 1 day
Participants complete health questionnaires and an in-person visit to provide blood samples and infant measurements. Metformin participants bring pill containers for adherence check.
1 visit (in-person)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
3
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American College of Obstetricians and Gynecologists Committee on Practice Bulletins--Obstetrics
https://pubmed.ncbi.nlm.nih.gov/11547793/Wanda K Nicholson, A Jenna Beckham, Karen Hatley...
https://pubmed.ncbi.nlm.nih.gov/27654119/Karst Y Heida, Arie Franx, Bas B van Rijn...
https://pubmed.ncbi.nlm.nih.gov/26459420/J Tuomilehto, J Lindström, J G Eriksson...
https://pubmed.ncbi.nlm.nih.gov/11333990/Leanne Bellamy, Juan-Pablo Casas, Aroon D Hingorani...
https://pubmed.ncbi.nlm.nih.gov/19465232/Matteo Cassina, Marta Donà, Elena Di Gianantonio...
https://pubmed.ncbi.nlm.nih.gov/24861556/Mohammed K Ali, Justin Echouffo-Tcheugui, David F Williamson
https://pubmed.ncbi.nlm.nih.gov/22232096/Argyro Syngelaki, Kypros H Nicolaides, Jyoti Balani...
https://pubmed.ncbi.nlm.nih.gov/26840133/William C Knowler, Elizabeth Barrett-Connor, Sarah E Fowler...
https://pubmed.ncbi.nlm.nih.gov/11832527/George Washington University
Lead Sponsor
University of North Carolina
Collaborating Sponsor
