A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gestational Weight Gain
- Sponsor
- Pennington Biomedical Research Center
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Body weight
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Detailed Description
One hundred pregnant women with obesity who are otherwise healthy will be studied from early pregnancy until approximately 2 weeks postpartum. Major assessments will occur at baseline (13-16 weeks gestation), 27-29 weeks gestation, 35-37 weeks gestation, and approximately 2 weeks postpartum. Safety assessments will be collected every 4 weeks after enrollment. Participants will be randomized within site (approximately 50 individuals at Pennington Biomedical Research Center and approximately 50 individuals at California Polytechnic University) and obesity to either: Provider Directed Group or Weight Maintenance Group.
Investigators
Leanne Redman
Professor
Pennington Biomedical Research Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Body weight
Time Frame: From study entry to approximately 2 weeks postpartum
Body weight will be measured using a calibrated electrical scale with participants wearing a hospital gown and underwear.
Secondary Outcomes
- Fat mass(From study entry to approximately 2 weeks postpartum)