Healthy Mamas: A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Grade 2 and 3 Obesity

Sponsor

Pennington Biomedical Research Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04731688

Collaborator

California Polytechnic State University-San Luis Obispo (Other), Oregon Health and Science University (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

100

Enrollment

Locations

Arms

44.7

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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 grade 2 and 3 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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Weight Gain Obesity	Behavioral: Weight Maintenance Group	N/A

Detailed Description

One hundred pregnant women with grade 2 or 3 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two site randomized controlled trialTwo site randomized controlled trial

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

A Weight Maintenance Program Promoting Fat Loss in Pregnancy in Women With Grade 2 and 3 Obesity

Actual Study Start Date :

Mar 10, 2021

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Are pregnant less than or equal to 15 weeks gestation at screening
Have a body mass index between 35.0 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Polytechnic State University	San Luis Obispo	California	United States	93407
2	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808