Fit After Baby: Increasing Postpartum Weight Loss in Women at Increased Risk for Cardiometabolic … (NCT03215173) | Clinical Trial Compass
CompletedNot Applicable
Fit After Baby: Increasing Postpartum Weight Loss in Women at Increased Risk for Cardiometabolic Disease
United States82 participantsStarted 2017-09-01
Plain-language summary
This study plans to learn more about how to increase postpartum weight loss and how to decrease risk factors for postpartum women at increased risk for diabetes and heart disease. The program is delivered using a mobile application (app) and a lifestyle coach. This mobile application is developed for women who are at higher risk for diabetes and heart disease. Women who have gestational diabetes, (diabetes during pregnancy, or GDM), gestational hypertension (high blood pressure), and/or preeclampsia (high blood pressure and protein in the urine), and/or small-for gestational-age, and/or preterm (early) delivery during their pregnancies have a higher risk for diabetes and heart disease. This mobile application was developed using the latest research studies and using the evidence-based Diabetes Prevention and Colorado Weigh programs. The goal of the program is to help women lose weight and participate in physical activity after delivery.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Age 18-45
✓. Postpartum Body Mass Index (BMI): 26- 45 kg/m2 (≥24 for Asians)
✓. Positive history of one or more of the following complications in most recent singleton or twin pregnancy:
✓. Gestational diabetes mellitus (by Carpenter-Coustan criteria, IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, or a documented clinical diagnosis). Women with a glucose value \>200 mg/dL after a 50-g glucose challenge test at \>12 weeks gestation will also be included.
✓. Preeclampsia (high blood pressure and proteinuria diagnosed after 20 weeks gestation)
✓. Gestational hypertension (new hypertension diagnosed after 20 weeks without proteinuria)
✓. Pre-term delivery (32-37 weeks)
✓. Small for gestational age (\<10th percentile for gestational age)
Exclusion criteria
✕. Personal history of Type 1 or 2 diabetes
What they're measuring
1
Change in weight loss from baseline to one year postpartum
Timeframe: Baseline (~6 weeks), 6 months, and 12 months
2
Change in postpartum weight retention
Timeframe: Pre-pregnancy, 6 weeks, 6 months, and 12 months