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

NCT04731688 | Completed DMC

• 2 other identifiers: PBRC 2019-0701R01DK124806-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Gestational Weight Gain; Obesity

Keywords

Pregnancy; Body Composition

Outcome Measures

Primary Outcomes (1)

• Body weight

  Body weight will be measured using a calibrated electrical scale with participants wearing a hospital gown and underwear.

  From study entry to approximately 2 weeks postpartum

Secondary Outcomes (1)

• Fat mass

  From study entry to approximately 2 weeks postpartum

Other Outcomes (8)

• Total body water

  From study entry to approximately 2 weeks postpartum

• Fat-free mass

  From study entry to approximately 2 weeks postpartum

• Fetal weight

  From 19-22 weeks gestation to 39-42 weeks gestation

Study Arms (2)

Weight Maintenance Group

EXPERIMENTAL

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

Provider Directed Group

NO INTERVENTION

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.

Interventions

Weight Maintenance Group BEHAVIORAL

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.

Weight Maintenance Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 100 pregnant women with obesity will be enrolled.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• California Polytechnic State University-San Luis Obispo: collaborator
• Oregon Health and Science University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

California Polytechnic State University

San Luis Obispo, California, 93407, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• Redman LM, Phelan S, Apolzan JW, Beyl RA, Altazan AD, Dickey MS, Simeon E, Flanagan EW, Cabre HE, Sparks JR, Kebbe M, Caughey AB, Valent AM, Hsia DS, Yin E, Keadle SK. Protocol for a randomised controlled trial of a weight maintenance intervention to promote fat loss in pregnant individuals with obesity. BMJ Open. 2025 Feb 25;15(2):e095804. doi: 10.1136/bmjopen-2024-095804.

  PMID: 40000086 DERIVED

MeSH Terms

Conditions

Gestational Weight Gain; Obesity

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Leanne M Redman, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be conducted by staff members who are masked to the participant's intervention group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two site randomized controlled trial

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 1, 2021
• Study Start: March 10, 2021
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)