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

Last updated: April 23, 2025
Sponsor: Pennington Biomedical Research Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Weight Maintenance Group

Clinical Study ID

NCT04731688
PBRC 2019-070
1R01DK124806-01
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 countermedications 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

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Weight Maintenance Group
Phase:
Study Start date:
March 10, 2021
Estimated Completion Date:
December 30, 2026

Study 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.

Connect with a study center

  • California Polytechnic State University

    San Luis Obispo, California 93407
    United States

    Active - Recruiting

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

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