RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-11
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06948825

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * BMI of 25 kg/m2 to 45 kg/m2
  3. * Singleton delivery
  4. * 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.
  1. * Pregnant or planned pregnancy within the next 6 months.
  2. * Participation in any other weight loss program or taking weight loss medication.
  3. * Normal or underweight BMI (BMI \< 24.9 kg/m2)
  4. * Multi-fetal (twins or triplets) gestation
  5. * 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.
  6. * Women whose infants have significant medical conditions, such as congenital heart disease, renal impairment, or hepatic impairment.

Contacts and Locations

Study Contact

Jennifer R Gomez Berrospi, MPH
CONTACT
202-994-2582
Jengomez291@gwu.edu
Wanda Nicholson, MD
CONTACT
wanda.nicholson@email.gwu.edu

Principal Investigator

Wanda Nicholson, MD
PRINCIPAL_INVESTIGATOR
The George Washington University

Study Locations (Sites)

Milken Institute School of Public Health - The George Washington University
Washington D.C., District of Columbia, 20052
United States

Collaborators and Investigators

Sponsor: George Washington University

  • Wanda Nicholson, MD, PRINCIPAL_INVESTIGATOR, The George Washington University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-11
Study Completion Date2026-08

Study Record Updates

Study Start Date2025-11
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

  • diabetes prevention
  • gestational diabetes
  • lifestyle intervention

Additional Relevant MeSH Terms

  • Weight Loss
  • Gestational Diabetes Mellitus in Pregnancy
  • Postpartum Care