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

Obesity Clinical Trial

— Healthy Mamas  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Obesity
• Weight Gain

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