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Can a lifestyle program beat a pill for Post-Diabetes weight loss?

NCT ID NCT06948825

Disease control Sponsor: George Washington University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a 6-month lifestyle program (diet, exercise, coaching) or the drug metformin is better for weight loss in mothers who recently had gestational diabetes. Sixty women who gave birth in the last year will join. Participants track their activity and weight, attend online group sessions, and may get extra support like free groceries. The goal is to find the most effective way to help these mothers lose weight and improve their health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metformin (a diabetes medication) and a lifestyle program (diet, exercise, and coaching)
What this could lead to
If it works, this could show that a lifestyle program is as good as or better than metformin for helping mothers lose weight after gestational diabetes, pointing toward a non-drug option.
What could go wrong
This is a small, early-phase study with only 60 people. Results may not apply to everyone, and weight loss can be hard to maintain. Metformin can cause stomach upset.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

gestational diabetes Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gestational diabetes mellitus in pregnancy Postpartum care Weight loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Milken Institute School of Public Health - The George Washington University

    RECRUITING

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

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