A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity

A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity

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.

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.

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