Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorGeorge Washington University
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Metformin Hcl 850Mg Tab
DrugParticipants randomized to Metformin will have a prescription of Metformin 850mg orally twice a day. The participant will get blood drawn for testing, undergo a urine pregnancy test, and meet with the study provider to discuss the medication.
Lifestyle Intervention
BehavioralParticipants in the Lifestyle Intervention will meet once a week via zoom with the study health counselor to go over lesson plans. After 4 weeks, participants will meet via zoom every other week.
Enhanced Lifestyle Intervention
BehavioralParticipants in the Enhanced Lifestyle Intervention will meet every other week, and will get a free instacart membership to have access to free grocery delivery. Additionally, participants in this intervention will have a 1:1 virtual meeting focused on meal planning with the study health counselor.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Enhanced Lifestyle (eLI)Active comparator 1 intervention
Group B: Metformin arm (MI)Active comparator 1 intervention
Group C: Lifestyle Intervention (LI)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean weight change at 6 months
Weight in kg.
Time frame
6 monthsSecondary outcomes
1
Change in physical activity
Measured using the Paffenberger Physical Activity Questionnaire, scores are calculated as total weekly energy expenditure in kilocalories per week; higher scores indicate better physical activity levels.
Time frame
6 months2
Change in blood pressure
Change in blood pressure, measured in mmHg. A better blood pressure reading is considered below 120/80 mmHg.
Time frame
6 months3
Change in A1c
Change in A1c lab value, measured in percentage (%), where a better A1c value is below 5.7%.
Time frame
6 months4
Change in lipids
Change in lipids, measured in mg/dL, where a better outcome is total cholesterol below 200mg/dL, HDL above 60 mg/dL, LDL below 100 mg/dL, and triglycerides below 150 mg/dL.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
George Washington University
Lead sponsor
University of North Carolina
Collaborator
Diabetes Sisters
Collaborator
American Diabetes Association
Collaborator
Source ClinicalTrials.gov