Status:
COMPLETED
A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
California Polytechnic State University-San Luis Obispo
Oregon Health and Science University
Conditions:
Gestational Weight Gain
Obesity
Eligibility:
FEMALE
18-45 years
Phase:
NA
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...
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 ges...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04731688
Start Date
March 10 2021
End Date
November 24 2025
Last Update
November 26 2025
Active Locations (2)
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1
California Polytechnic State University
San Luis Obispo, California, United States, 93407
2
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808