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

Study Overview
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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.

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 equally randomized within site (50 individuals at Pennington Biomedical Research Center and 50 individuals at California Polytechnic University) and obesity grade 2 or 3 to either: Provider Directed Group or Weight Maintenance Group.

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

Conditions
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Gestational Weight Gain, Obesity

Intervention / Treatment
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* Behavioral: Weight Maintenance Group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two site randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Maintenance Group<br>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<br>* 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.<br>|
| No Intervention: Provider Directed Group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight change from early pregnancy to end of pregnancy | Body weight will be measured using a calibrated electrical scale with participants wearing a hospital gown and underwear. | 13-16 weeks gestation and 35-37 weeks gestation | 
| Fat mass change from early pregnancy to end of pregnancy | 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. | 13-16 weeks gestation and 35-37 weeks gestation | 
| Total body water change from early pregnancy to end of pregnancy | Total body water is assessed by deuterium dilution. | 13-16 weeks gestation and 35-37 weeks gestation | 
| Fat-free mass change from early pregnancy to end of pregnancy | Fat-free mass will be calculated as the subtraction of fat mass from total body weight. | 13-16 weeks gestation and 35-37 weeks gestation | 
| Body weight change from early pregnancy to approximately 2 weeks postpartum | Body weight will be measured using a calibrated electrical scale with participants wearing a hospital gown and underwear. | 13-16 weeks gestation and approximately 2 weeks postpartum | 
| Fat mass change from early pregnancy 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. | 13-16 weeks gestation and approximately 2 weeks postpartum | 
| Total body water change from early pregnancy to approximately 2 weeks postpartum | Total body water is assessed by deuterium dilution. | 13-16 weeks gestation and approximately 2 weeks postpartum | 
| Fat-free mass change from early pregnancy to approximately 2 weeks postpartum | Fat-free mass will be calculated as the subtraction of fat mass from total body weight. | 13-16 weeks gestation and approximately 2 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Body Composition