Recruiting

Exercise

Sponsor:

East Carolina University

Code:

NCT04805502

Conditions

Pregnancy

Overweight and Obesity

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Exercise Modes

Study Details

Brief summary:

The overall objective of this proposal is to conduct a longitudinal prospective study of overweight/obese (OW/OB) pregnant women and their offspring to determine which prenatal exercise mode will have the greatest impact on maternal and infant cardiometabolic health. This information may lead to clinical practice recommendations that improve childhood health. This randomized controlled trial will recruit 284 OW/OB pregnant women randomized to an exercise intervention (aerobic (AE), resistance (RE), or aerobic+resistance exercise (AERE)) or to no exercise; their infants will be measured at 1, 6, and 12 months of age. This design will test our central hypothesis that AERE and RE training during pregnancy will improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. This hypothesis will be tested with two specific aims:

Aim 1. Determine the influence of different exercise modes during OW/OB pregnancy on infant cardiometabolic health and growth trajectories. Hypothesis: AE, RE, and AERE by OW/OB pregnant women will improve offspring neuromotor and cardiometabolic measures at 1, 6, and 12 months postpartum (e.g. decreased %body fat, BMI z-score, heart rate \[HR\], non-HDL, and C-Reactive Protein (CRP); increased insulin sensitivity) compared to infants of OW/OB pregnant women that do not exercise; AERE and RE will have the greatest impact on improving infant measures.

Aim 2. Determine the most effective exercise mode in OW/OB pregnancy on improving maternal cardiometabolic health outcomes. Hypothesis: AE, RE, and AERE by OW/OB pregnant women will improve both maternal cardiometabolic health measures (e.g. decreased BMI z-score, non-HDL, % body fat, HR, weight gain) across pregnancy (16-36 weeks' gestation) and overall pregnancy outcomes (e.g. lower incidence of gestational diabetes, pre-eclampsia, hypertension during gestation) compared to OW/OB pregnant women that do not exercise; AERE and RE will have the greatest impact on improving maternal health measures, with the AERE group having the highest compliance.

The proposed study will be the first to provide an understanding of the influence of maternal exercise modes on the cardiometabolic health and growth trajectories of offspring who are at increased risk due to maternal OW/OB. This work will have a significant impact on reducing the cycle of OB, potentially providing the earliest and most efficacious intervention to decrease or prevent OB in the next generation.

Conditions

Pregnancy

Overweight and Obesity

Study ID

NCT04805502

Start date

Oct 18, 2021

Status verified date

Mar, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age: 18 to 40 years old
  • BMI between ≥ 25
  • Pregnancy: Singleton; ≤ 16 weeks gestation
  • Clearance by Obstetric provider for exercise

Exclusion Criteria:

  • Age: ≤ 17.9 or ≥ 41 years of age
  • BMI <25
  • Multi fetal pregnancy
  • Obstetric Provider does not provide clearance for exercise
  • Unable or Unwilling to provide consent
  • Inability to communicate with members of study team, despite use of interpreter
  • Medical Conditions (e,g. HIV/Aids, Cancer, Type 1 or 2 Diabetes, Untreated Hypertension, Thyroid Disorders)
  • Use of tobacco products, alcohol, recreational drugs, or medications (oral hypertensive, insulin)
  • Unable to provide phone or email contact

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Aerobic Exercise (AE)

All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.

The AE group will exercise on aerobic machines (i.e. treadmill, elliptical, bicycle) for all of their sessions.

experimental: Resistance Exercise (RE)

All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.

The RE group will perform 12-15 repetitions of 10-12 resistance exercises in a circuit, for 3 sets with rest period of 30-60 seconds between sets as needed.\[100\] Seated isokinetic exercise using Cybex machines will target all major muscle groups. Light dumbbells and resistance bands will be used if the participant is unable to lift the minimal load on Cybex machines. Core exercises will be performed at the end of the session (i.e. seated side bends).

experimental: Combination Exercise (AERE)

All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, RPE, 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data.

The AERE group will switch between AE exercise and RE; for this group, RE exercises will consist of 1 set of 12-15 repetitions of 4 resistance exercises, then 5 minutes of AE, then repeated repeat with different exercises.\[106-108\] The investigators will also calculate the metabolic minutes per week (METmin/wk) of all participants in order to account for potential differences in energy expenditure based on activity, though the dose of 150 min/wk at moderate intensity is held constant between exercise groups.

no intervention: Control (no exercise)

The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.

Interventions

Exercise Modes

Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise

Primary outcome measure

  • 1 month Infant non-HDL [ Time Frame: 1 month ]
  • 6 month Infant non-HDL [ Time Frame: 6 months ]
  • 12 month Infant non-HDL [ Time Frame: 12 months ]
  • 1 month Infant BMI z-score [ Time Frame: 1 month ]
  • 6 month Infant BMI z-score [ Time Frame: 6 months ]
  • 12 month Infant BMI z-score [ Time Frame: 12 months ]
  • Enrollment (8-13wks) Maternal fasting non-HDL [ Time Frame: enrollment (~8-13 wks gestation) ]
  • 36wk Maternal fasting non-HDL [ Time Frame: 36 weeks gestation ]
  • 1 month postpartum Maternal fasting non-HDL [ Time Frame: 1 month postpartum ]
  • 6 months postpartum Maternal fasting non-HDL [ Time Frame: 6 months postpartum ]
  • Adverse Pregnancy Outcomes [ Time Frame: At Delivery ]

Central Contacts and Locations

Central contacts

Linda E May, MS, PhD

2527377072mayl@ecu.edu

Jameta Edwards

2527377156edwardsja@ecu.edu

Locations

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Linda E May, MS, PhD

2527377072mayl@ecu.edu

James DeVente, MD

deventeja@ecu.edu

More Information

Sponsor

East Carolina University

Last update posted

Jun 4, 2026

Last verified

Mar, 2026

Keywords

  • exercise modes, exercise intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by East Carolina University on 2026-06-04.