A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2025-11-24

Brief Summary

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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.

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Detailed Description

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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

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Gestational Weight Gain Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two site randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessments will be conducted by staff members who are masked to the participant's intervention group assignment.

Study Groups

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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.

Group Type EXPERIMENTAL

Weight Maintenance Group

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes