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

Completed · Not applicable

Conditions studied: Gestational Weight Gain, Obesity

In brief

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.

Key facts

Study ID

NCT04731688

Run by

Pennington Biomedical Research Center

People needed

100

Starts

2021-03-10

Expected to finish

2025-11-24

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California Polytechnic State University — San Luis Obispo, California, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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