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NCT06948825 · ClinicalTrials.gov registry record · Phase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
A Phase 2 study of Weight Loss and Gestational Diabetes Mellitus in Pregnancy, sponsored by George Washington University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06948825 is a Phase 2 study of Weight Loss and Gestational Diabetes Mellitus in Pregnancy that is actively recruiting participants, run by George Washington University. The registered enrollment target is 60 participants, below the 1,501-participant average among 116 other Weight Loss trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06948825, a Phase 2 study of Weight Loss and Gestational Diabetes Mellitus in Pregnancy, is actively recruiting participants, sponsored by George Washington University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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 test
Conditions Studied
Interventions
- BEHAVIORAL Lifestyle Intervention
- DRUG Metformin Hcl 850Mg Tab
- BEHAVIORAL Enhanced Lifestyle Intervention
Study Locations (1)
District of Columbia
- Milken Institute School of Public Health - The George Washington University - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-10-27 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06948825
The ClinicalTrials.gov registry entry for NCT06948825 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,501-participant average among 116 other Weight Loss trials with a reported enrollment target (96% lower). The listed sponsor is George Washington University, which has 133 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Weight Loss appearing as the primary indexed condition, and to 3 interventions - of which Lifestyle Intervention is the first listed.
NCT06948825 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06948825 about?
NCT06948825 is a clinical study titled "Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes". 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 questio...
What is the current status of trial NCT06948825?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-10-27. Estimated completion is 2026-11.
What conditions does trial NCT06948825 study?
This clinical trial studies the following conditions: Weight Loss, Gestational Diabetes Mellitus in Pregnancy, Postpartum Care.
What interventions are being tested in trial NCT06948825?
The interventions under investigation include: Lifestyle Intervention (BEHAVIORAL), Metformin Hcl 850Mg Tab (DRUG), Enhanced Lifestyle Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06948825?
This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06948825 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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