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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04731688
Other study ID # PBRC 2019-070
Secondary ID 1R01DK124806-01
Status Recruiting
Phase N/A
First received
Last updated
Start date March 10, 2021
Est. completion date December 30, 2026

Study information

Verified date March 2024
Source Pennington Biomedical Research Center
Contact Abby D Altazan, M.S.
Phone 225-763-2801
Email Abby.Altazan@pbrc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 30, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana
United States California Polytechnic State University San Luis Obispo California

Sponsors (4)

Lead Sponsor Collaborator
Pennington Biomedical Research Center California Polytechnic State University-San Luis Obispo, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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