NCT04731688Completed
A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 26 Jan 2021
- Start date
- 10 Mar 2021
- Primary completion date
- 24 Nov 2025
- Lead sponsor
- Pennington Biomedical Research Center
- Diseases
- Obesity
- NCT number
- NCT04731688
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 10 Mar 2021 to the primary completion date, 24 Nov 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Smoking, drug, or alcohol use
- 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
Other illness
- Have a non-pregnancy related illness
- Have pre-existing diabetes
- Have pre-existing hypertension
- Have current mental health issue or eating disorder
Other
- Have a known fetal anomaly
- Have severe anemia
- Short inter-pregnancy interval (\<6 months since last pregnancy)
- Use of assisted reproductive technology
- Planning to move out of the area in the next 12 months
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pennington Biomedical Research Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Unknown status |
| California Polytechnic State University Coordinator of this site? Confirm its status | San Luis Obispo | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.