A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity (Healthy Mamas)

August 6, 2026 updated by: Leanne Redman, Pennington Biomedical Research Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 gestation), 27-29 weeks gestation, 35-37 weeks gestation, and approximately 2 weeks postpartum. Safety assessments will be collected every 4 weeks after enrollment. Participants will be randomized within site (approximately 50 individuals at Pennington Biomedical Research Center and approximately 50 individuals at California Polytechnic University) and obesity to either: Provider Directed Group or Weight Maintenance Group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • San Luis Obispo, California, United States, 93407
        • California Polytechnic State University
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Weight Maintenance Group
Individuals in this group will receive all aspects of the Provider Directed Group plus a comprehensive behavioral fat mass loss intervention with food provision. Individuals in this group will be provided foods to eat to support weight maintenance and loss of body fat throughout pregnancy. They will be asked to attend two behavioral counseling sessions at the beginning of the study to help learn the program and set goals. They will return for brief visits with a lifestyle counselor every two weeks until 20 weeks gestation and at least once a month until delivery. Individuals will be provided a scale to help keep track of weight during pregnancy.
Behavioral: Weight Maintenance Group
The behavioral program is rooted in social learning theory and based on our existing prenatal intervention but with full food provision to ensure gestational fat mass loss is steady and closely supervised. Brief counseling sessions are designed to review self-monitoring records, reinforce adherence to the structured food provision program, problem-solve barriers, and provide additional support. Individuals will be provided with a structured meal plan designed to promote 25% calorie restriction during the second trimester followed by eucaloric intake during the 3rd trimester. Participants will be provided three meals and two snacks on 7 days at no cost.
No Intervention: Provider Directed Group
Individuals in this group will receive what is standard practice by their prenatal care providers during pregnancy. In addition, individuals in this group will be asked to attend a brief session at the time of randomization to familiarize with the study and what is expected. They will also be provided with materials describing healthy behaviors in pregnancy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: From study entry to approximately 2 weeks postpartum
Body weight will be measured using a calibrated electrical scale with participants wearing a hospital gown and underwear.
From study entry to approximately 2 weeks postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fat mass
Time Frame: From study entry to approximately 2 weeks postpartum
Fat mass will be assessed via a 3-compartment model in which fat mass is calculated from body weight, body density measured by the BODPOD, and total body water measured by deuterium dilution.
From study entry to approximately 2 weeks postpartum

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total body water
Time Frame: From study entry to approximately 2 weeks postpartum
Total body water is assessed by deuterium dilution.
From study entry to approximately 2 weeks postpartum
Fat-free mass
Time Frame: From study entry to approximately 2 weeks postpartum
Fat-free mass will be calculated as the subtraction of fat mass from total body weight.
From study entry to approximately 2 weeks postpartum
Fetal weight
Time Frame: From 19-22 weeks gestation to 39-42 weeks gestation
Fetal weight is measured by ultrasound and estimated by Hadlock formula.
From 19-22 weeks gestation to 39-42 weeks gestation
Infant body composition
Time Frame: Approximately 2 weeks old
Infant body composition will be assessed via a 3-compartment model which includes body weight, PEAPOD, and dual-energy x-ray absorptiometry.
Approximately 2 weeks old
Dietary intake
Time Frame: From study entry to 35-37 weeks gestation
Dietary intake is assessed by automated self-administered 24-hour dietary assessment tool (ASA-24).
From study entry to 35-37 weeks gestation
Metabolic syndrome score
Time Frame: From study entry to approximately 2 weeks postpartum
Metabolic syndrome score will be determined using measured blood pressure and waist circumference, and triglycerides, high density lipoprotein cholesterol, and glucose.
From study entry to approximately 2 weeks postpartum
Perinatal outcomes
Time Frame: From study entry to approximately 2 weeks postpartum
All perinatal outcomes (ie non-elective cesarean delivery, gestational diabetes, hypertension, pre-eclampsia) will be obtained by prenatal and delivery medical chart abstraction.
From study entry to approximately 2 weeks postpartum
Time Spent in Physical activity
Time Frame: From study entry to 35-37 weeks gestation
Physical activity (amount of time spent in physical activity) is assessed by activPAL activity device over a period of 5-7 days.
From study entry to 35-37 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pennington Biomedical Research Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Oregon Health and Science University
California Polytechnic State University-San Luis Obispo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leanne M Redman, Ph.D., Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 24, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PBRC 2019-070
  • 1R01DK124806-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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