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

Not Applicable

Active, not recruiting

• Conditions: Obesity; Gestational Weight Gain
• Interventions: Behavioral: Weight Maintenance Group

• Registration Number: NCT04731688
• Lead Sponsor: Pennington Biomedical Research Center

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.

Study Timeline

• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-02-01
• Study Start: 2021-03-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight Maintenance Group	Weight Maintenance Group	Individuals in this group will receive all aspects of the Provider Directed Group plus a comprehensive behavioral fat mass loss intervention with food provision. Individuals in this group will be provided foods to eat to support weight maintenance and loss of body fat throughout pregnancy. They will be asked to attend two behavioral counseling sessions at the beginning of the study to help learn the program and set goals. They will return for brief visits with a lifestyle counselor every two weeks until 20 weeks gestation and at least once a month until delivery. Individuals will be provided a scale to help keep track of weight during pregnancy.

Primary Outcome Measures

Name	Time	Method
Body weight	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 Outcome Measures

Name	Time	Method
Fat mass	From study entry to approximately 2 weeks postpartum	Fat mass will be assessed via a 3-compartment model in which fat mass is calculated from body weight, body density measured by the BODPOD, and total body water measured by deuterium dilution.

Trial Locations

Locations (2)

California Polytechnic State University; 🇺🇸 San Luis Obispo, California, United States

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States