No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 45
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
60 (estimated)
Sponsor
George Washington University · Other
Who this trial is looking for
This trial is looking for mothers who are 8 weeks to 12 months postpartum after a pregnancy with gestational diabetes. Participants will receive either lifestyle support or Metformin and will track their weight and health over six months.
I am a mother between 8 weeks and 12 months postpartum.
I had a pregnancy complicated by gestational diabetes.
I have a BMI between 25 and 45.
I had a singleton delivery.
I have a working cell phone.
I am willing to participate in online sessions.
You may not be able to join if
I am pregnant or planning to get pregnant in the next 6 months.
I am taking any weight loss medication.
I have a normal or underweight BMI.
I am carrying twins or triplets.
I have type 1 or type 2 diabetes.
I have serious health issues like advanced kidney disease.
My infant has significant medical conditions like heart disease.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility Criteria
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 partici…
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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