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Completed

NCT Number: NCT04731688

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

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

California Polytechnic State University, San Luis Obispo, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Body weight

    Time frame: 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 outcomes

  1. Fat mass

    Time frame: 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.

Other outcomes

  1. Total body water

    Time frame: From study entry to approximately 2 weeks postpartum

    Total body water is assessed by deuterium dilution.

  2. Fat-free mass

    Time frame: From study entry to approximately 2 weeks postpartum

    Fat-free mass will be calculated as the subtraction of fat mass from total body weight.

  3. Fetal weight

    Time frame: From 19-22 weeks gestation to 39-42 weeks gestation

    Fetal weight is measured by ultrasound and estimated by Hadlock formula.

  4. Infant body composition

    Time frame: Approximately 2 weeks old

    Infant body composition will be assessed via a 3-compartment model which includes body weight, PEAPOD, and dual-energy x-ray absorptiometry.

  5. Dietary intake

    Time frame: From study entry to 35-37 weeks gestation

    Dietary intake is assessed by automated self-administered 24-hour dietary assessment tool (ASA-24).

  6. Time Spent in Physical activity

    Time frame: From study entry to 35-37 weeks gestation

    Physical activity (amount of time spent in physical activity) is assessed by activPAL activity device over a period of 5-7 days.

  7. Metabolic syndrome score

    Time frame: From study entry to approximately 2 weeks postpartum

    Metabolic syndrome score will be determined using measured blood pressure and waist circumference, and triglycerides, high density lipoprotein cholesterol, and glucose.

  8. Perinatal outcomes

    Time frame: From study entry to approximately 2 weeks postpartum

    All perinatal outcomes (ie non-elective cesarean delivery, gestational diabetes, hypertension, pre-eclampsia) will be obtained by prenatal and delivery medical chart abstraction.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • California Polytechnic State University-San Luis Obispo
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Oregon Health and Science University

Registry information

Acronym: Healthy Mamas

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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