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COMPLETED
NCT04731688
NA

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

Sponsor: Pennington Biomedical Research Center

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2021-03-10

Completion Date

2025-11-24

Last Updated

2026-08-10

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Weight Maintenance Group

The behavioral program is rooted in social learning theory and based on our existing prenatal intervention but with full food provision to ensure gestational fat mass loss is steady and closely supervised. Brief counseling sessions are designed to review self-monitoring records, reinforce adherence to the structured food provision program, problem-solve barriers, and provide additional support. Individuals will be provided with a structured meal plan designed to promote 25% calorie restriction during the second trimester followed by eucaloric intake during the 3rd trimester. Participants will be provided three meals and two snacks on 7 days at no cost.

Locations (2)

California Polytechnic State University

San Luis Obispo, California, United States

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States