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

Pennington Biomedical Research Center

Status: Enrolling

Conditions: Obesity; Gestational Weight Gain

Treatments: Behavioral: Weight Maintenance Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04731688

1R01DK124806-01 (U.S. NIH Grant/Contract)

PBRC 2019-070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Weight Maintenance Group

Experimental group

Description:

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.

Treatment:

Behavioral: Weight Maintenance Group

Provider Directed Group

No Intervention group

Description:

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.