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Pregnancy weight program aims to cut risks for moms with obesity

NCT ID NCT04731688

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

100 people

The number who actually took part.

Started

Mar 2021

Finished

Nov 2025

Lead sponsor

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

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

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.

Gestational Weight Gain Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • California Polytechnic State University

    San Luis Obispo, California, 93407, United States

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808, United States

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