A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity (NCT04731688) | Clinical Trial Compass
CompletedNot Applicable
A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity
United States100 participantsStarted 2021-03-10
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Body weight
Timeframe: From study entry to approximately 2 weeks postpartum