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

RecruitingPhase 2Ages 18 Years - 45 YearsFemaleGeorge Washington University
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In plain words

What the trial is, and whether it could suit you

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 s

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Metformin Hcl 850Mg Tab
  • Lifestyle Intervention
  • Enhanced Lifestyle Intervention
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Where

1 site
Milken Institute School of Public Health - The George Washington University
Washington D.C., United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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