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Sponsor: Pennington Biomedical Research Center
Conditions: Gestational Weight Gain, Obesity
Interventions: Weight Maintenance Group
Countries: United States
The aims of this randomized controlled trial are to determine the effects of a lifestyle program that supports weight maintenance and fat mass loss during pregnancy in women with obesity on changes in 1) maternal weight, fat mass, and cardiometabolic risk factors; 2) safety measures, including fetal and neonatal growth; 3) the mediators and moderators of the fat mass loss intervention and 4) the effects gestational fat mass loss has on reducing incidence of adverse obstetrical outcomes, including non-elective cesarean delivery, gestational diabetes, hypertension, and pre-eclampsia.
Sex: FEMALE
Age: 18 Years to 45 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * Are pregnant less than or equal to 15 weeks gestation at screening * Have a body mass index between 31.0 and 55.0 inclusive * Have a confirmed viable singleton gestation * Willing to receive randomization to either group * Willing and able to eat the study foods * Willing to enroll infant for study measurements after birth * Receive clearance from the prenatal care provider for participation Exclusion Criteria: * Smoking, drug, or alcohol use * Have a known fetal anomaly * Have a non-pregnancy related illness * Have pre-existing diabetes * Have pre-existing hypertension * Have severe anemia * Have current mental health issue or eating disorder * Short inter-pregnancy interval (\<6 months since last pregnancy) * Use of assisted reproductive technology * Use of medications with known effects on body weight including over the counter medications and supplements for weight loss * History of pre-eclampsia, prior small for gestational age infant, bariatric surgery * Planning to move out of the area in the next 12 months
- San Luis Obispo, California, United States
- Baton Rouge, Louisiana, United States