Gestational Weight GainHealthy MamasNCT04731688
A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity
A study testing Weight Maintenance Group in people with Gestational Weight Gain and Obesity, run by Pennington Biomedical Research Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Weight Gain, Obesity
- What is being tested?
- Weight Maintenance Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Mar 2021to 24 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
California Polytechnic State University
San Luis Obispo, California, 93407
About this study
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.
Read the 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.
- Conditions
- Gestational Weight Gain, Obesity
- Being tested
- Weight Maintenance Group
- Keywords
- Pregnancy, Body Composition
- Medical subject headings
- Gestational Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Maintenance GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Weight Maintenance Group | Experimental | 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. Receives: Behavioral: Weight Maintenance Group |
| Provider Directed Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight will be measured using a calibrated electrical scale with participants wearing a hospital gown and underwear.
Measured: From study entry to approximately 2 weeks postpartum
Secondary outcomes (1)
Fat mass
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.
Measured: From study entry to approximately 2 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start10 Mar 2021
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two site randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- California Polytechnic State University-San Luis Obispo, Oregon Health and Science University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Leanne Redman, Pennington Biomedical Research Center
- Investigators
- Leanne M Redman, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731688
- Sponsor's protocol ID
- PBRC 2019-070
- Other IDs
- 1R01DK124806-01
- Acronym
- Healthy Mamas
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2021
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Redman LM, Phelan S, Apolzan JW, Beyl RA, Altazan AD, Dickey MS, Simeon E, Flanagan EW, Cabre HE, Sparks JR, Kebbe M, Caughey AB, Valent AM, Hsia DS, Yin E, Keadle SK. Protocol for a randomised controlled trial of a weight maintenance intervention to promote fat loss in pregnant individuals with obesity. BMJ Open. 2025 Feb 25;15(2):e095804. doi: 10.1136/bmjopen-2024-095804.
PubMed 40000086
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity
- ClinicalTrials.gov ID
- NCT04731688
- Acronym / sponsor ID
- Healthy Mamas / PBRC 2019-070
- Conditions
- Gestational Weight Gain, Obesity
- Keywords
- Pregnancy, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- California Polytechnic State University-San Luis Obispo, Oregon Health and Science University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two site randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Weight Maintenance Group | Experimental | Behavioral: Weight Maintenance GroupIndividuals 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. |
| Provider Directed Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- Smoking, drug, or alcohol use
- Have a known fetal anomaly
- Have a non-pregnancy related illness
- Have pre-existing diabetes
- Have pre-existing hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight Maintenance GroupThe 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. | Behavioural | Weight Maintenance Group |
Primary outcome
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.
1 secondary outcome
Fat mass
Time frame: From study entry to approximately 2 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Derived from this study: PubMed 40000086Redman LM, Phelan S, Apolzan JW, Beyl RA, Altazan AD, Dickey MS, Simeon E, Flanagan EW, Cabre HE, Sparks JR, Kebbe M, Caughey AB, Valent AM, Hsia DS, Yin E, Keadle SK. Protocol for a randomised controlled trial of a weight maintenance intervention to promote fat loss in pregnant individuals with obesity. BMJ Open. 2025 Feb 25;15(2):e095804. doi: 10.1136/bmjopen-2024-095804.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leanne M Redman, Ph.D. principal investigator
Pennington Biomedical Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight Maintenance Group in people with Gestational Weight Gain and Obesity, run by Pennington Biomedical Research Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: From study entry to approximately 2 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04731688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.