Pregnancy weight program aims to cut risks for moms with obesity
NCT ID NCT04731688
First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This study tested a lifestyle program to help pregnant women with obesity maintain their weight and lose body fat during pregnancy. About 100 women in early pregnancy took part, receiving either the program or standard care. The goal was to see if the program could improve mother and baby health, such as reducing risks for diabetes, high blood pressure, and cesarean delivery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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100 people
The number who actually took part.
- Started
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Mar 2021
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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California Polytechnic State University
San Luis Obispo, California, 93407, United States
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
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