Gestational Weight Gain, Obesity
Conditions
Keywords
Pregnancy, Body Composition
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 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.
Interventions
BEHAVIORALWeight 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.
Sponsors
Pennington Biomedical Research Center
California Polytechnic State University-San Luis Obispo
Oregon Health and Science University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessments will be conducted by staff members who are masked to the participant's intervention group assignment.
Intervention model description
Two site randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fat mass | From study entry 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLeanne M Redman, Ph.D.
Pennington Biomedical Research Center
Outcome results
None listed