Recruiting
Phase 2

Lifestyle Intervention & Metformin

Sponsor:

George Washington University

Code:

NCT06948825

Conditions

Weight Loss

Gestational Diabetes Mellitus in Pregnancy

Postpartum Care

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Metformin Hcl 850Mg Tab

Lifestyle Intervention

Enhanced Lifestyle Intervention

Study Details

Brief summary:

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

Weight Loss

Gestational Diabetes Mellitus in Pregnancy

Postpartum Care

Study ID

NCT06948825

Start date

Oct 27, 2025

Status verified date

Jan, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Enhanced Lifestyle (eLI)

Participants will continue with the same components as the Lifestyle Intervention (LI), with the addition of guidance on healthy meal planning and online grocery shopping, including one free delivery per week via instacart. If randomized to this group, participants will continue to have group sessions every other week with others in the eLI arm of the study for the duration of the study (5 or 4.5 months depending on when they were randomized to the Metformin arm) for a total of a 6-month intervention. Group sessions will last 45-60 minutes each. These sessions will be led by a trained health counselor.

active comparator: Metformin arm (MI)

Participants in this arm will have an individual in-person session with the health counselor and study provider where they receive information about 1) the risks and benefits of Metformin for weight loss, 2) potential risks of infant hypoglycemia and the signs/symptoms of infant hypoglycemia, 3) risk factors for development of infant hypoglycemia and the potential long-term effects and consequences of infant hypoglycemia and, 4) guidance on how to take Metformin.

Participants will be placed on Metformin by mouth (850 mg daily x 7 days, then 850 mg twice daily) and will have a 15-minute follow-up call one week after starting the medication to answer additional questions, assess for any medication side effects, and assess for adherence, and then 15-minute follow-up calls by the research team every 2 weeks. Participants will be encouraged to continue practicing healthy lifestyle behaviors learned during the first 4 weeks of the intervention.

active comparator: Lifestyle Intervention (LI)

All participants will begin with the DPP-based Lifestyle Intervention (LI). This arm includes weekly online 45-minute Zoom group sessions for 4 weeks. After week 4, Zoom group sessions will be biweekly. The goal is a 2% weight loss at 4 weeks and a 3% weight loss at 6 weeks. If participants reach their weight loss goal, they will continue in this arm of the study. These sessions will be led by a trained health counselor.

Interventions

Metformin Hcl 850Mg Tab

Participants randomized to Metformin will have a prescription of Metformin 850mg orally twice a day. The participant will get blood drawn for testing, undergo a urine pregnancy test, and meet with the study provider to discuss the medication.

Lifestyle Intervention

Participants in the Lifestyle Intervention will meet once a week via zoom with the study health counselor to go over lesson plans. After 4 weeks, participants will meet via zoom every other week.

Enhanced Lifestyle Intervention

Participants in the Enhanced Lifestyle Intervention will meet every other week, and will get a free instacart membership to have access to free grocery delivery. Additionally, participants in this intervention will have a 1:1 virtual meeting focused on meal planning with the study health counselor.

Primary outcome measure

  • Mean weight change at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Jennifer R Gomez Berrospi, MPH

202-994-2582Jengomez291@gwu.edu

Wanda Nicholson, MD

wanda.nicholson@email.gwu.edu

Locations

Milken Institute School of Public Health - The George Washington University

Recruiting

Washington D.C., District of Columbia, United States, 20052

Contacts

Jennifer Gomez, MPH

202-994-2582Jengomez291@gwu.edu

More Information

Sponsor

George Washington University

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Keywords

  • diabetes prevention
  • gestational diabetes
  • lifestyle intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by George Washington University on 2026-01-13.