Lifestyle Intervention vs Metformin for Gestational Diabetes
(GooDMomS2 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are taking weight loss medication, you cannot participate in the trial.
What data supports the effectiveness of the treatment Enhanced Lifestyle Intervention, Lifestyle Intervention, Metformin for gestational diabetes?
Research shows that lifestyle interventions can help prevent type 2 diabetes in women with a history of gestational diabetes, although results can vary. Additionally, using metformin along with lifestyle changes has been shown to improve outcomes for women with gestational diabetes compared to lifestyle changes alone.12345
Is metformin safe for pregnant women with gestational diabetes?
How does the treatment of lifestyle intervention and metformin differ from other treatments for gestational diabetes?
The combination of lifestyle intervention and metformin for gestational diabetes is unique because it combines non-drug strategies like diet and exercise with a medication that helps control blood sugar levels. This approach can be an effective alternative to insulin, especially for women with higher body mass index (BMI), and may reduce the need for additional insulin therapy.28101112
What is the purpose of this trial?
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.
Research Team
Wanda Nicholson, MD
Principal Investigator
The George Washington University
Eligibility Criteria
This trial is for postpartum women who had a single, live birth in the last 12 weeks to 1 year and experienced gestational diabetes. They should be interested in weight loss and willing to use digital tracking tools and attend online sessions. Details about specific inclusion or exclusion criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants 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.
Lifestyle Intervention
Participants begin with a DPP-based Lifestyle Intervention, including weekly online 45-minute Zoom group sessions for 4 weeks, then biweekly sessions. The goal is a 2% weight loss at 4 weeks and a 3% weight loss at 6 weeks.
Randomization and Treatment
Participants not meeting weight loss goals are randomized to either Enhanced Lifestyle Intervention or Metformin. Enhanced Lifestyle includes meal planning and grocery delivery. Metformin involves medication and follow-up calls.
Follow-up
Participants are monitored for safety and effectiveness after treatment. At the end of the study, participants complete questionnaires and attend an in-person visit for final assessments.
Treatment Details
Interventions
- Enhanced Lifestyle Intervention
- Lifestyle Intervention
- Metformin
Find a Clinic Near You
Who Is Running the Clinical Trial?
George Washington University
Lead Sponsor
American Diabetes Association
Collaborator
Diabetes Sisters
Collaborator
University of North Carolina
Collaborator