Actively Recruiting

Phase 2
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID06948825

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

N/A

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

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 infant's 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

Brief Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Mothers between 8 weeks and 12 months postpartum from a pregnancy complicated by gestational diabetes
  • Body mass index (BMI) between 25 kg/m2 and 45 kg/m2
  • Delivered a single baby (singleton delivery)
  • Have a working cell phone and be willing to receive emails or text messages
  • Willing to attend Zoom group sessions
  • Agree to possible randomization to Metformin drug therapy
Not Eligible

You will not qualify if you...

  • Currently pregnant or planning pregnancy within the next 6 months
  • Participating in any other weight loss program or taking weight loss medication
  • Normal or underweight BMI (less than 24.9 kg/m2)
  • Multiple pregnancy (twins or triplets)
  • Diagnosed with type 1 or type 2 diabetes, cancer, advanced kidney disease, severe heart or lung disease, schizophrenia or other major psychiatric illness, substance abuse, or AIDS
  • Infant has significant medical conditions such as congenital heart disease, kidney or liver impairment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment

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)

Lifestyle Intervention (LI)

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

Intervention Assignment and Continuation

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

Enhanced Lifestyle Intervention (eLI)

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

Metformin Treatment

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

End of Study Assessment

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)

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

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Research Team

J

Jennifer R Gomez Berrospi, MPH

W

Wanda Nicholson, MD

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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Published Research Related To This Trial

Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007-2010.

Carla L DeSisto, Shin Y Kim, Andrea J Sharma

https://pubmed.ncbi.nlm.nih.gov/24945238

Earlier Age of Onset of Chronic Hypertension and Type 2 Diabetes Mellitus After a Hypertensive Disorder of Pregnancy or Gestational Diabetes Mellitus.

Karst Y Heida, Arie Franx, Bas B van Rijn...

https://pubmed.ncbi.nlm.nih.gov/26459420