Pregnancy Exercise Mode Effect on Childhood Obesity

NCT04805502 | Recruiting DMC

• 1 other identifier: 19-001863
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

exercise modes, exercise intervention

Outcome Measures

Primary Outcomes (11)

• 1 month Infant non-HDL

  non-HDL measured from venipuncture

  1 month

• 6 month Infant non-HDL

  non-HDL measured from venipuncture

  6 months

• 12 month Infant non-HDL

  non-HDL measured from venipuncture

  12 months

• 1 month Infant BMI z-score

  BMI normalized

  1 month

• 6 month Infant BMI z-score

  BMI normalized

  6 months

• 12 month Infant BMI z-score

  BMI normalized

  12 months

• Enrollment (8-13wks) Maternal fasting non-HDL

  non-HDL measured from venipuncture

  enrollment (~8-13 wks gestation)

• 36wk Maternal fasting non-HDL

  non-HDL measured from venipuncture

  36 weeks gestation

• 1 month postpartum Maternal fasting non-HDL

  non-HDL measured from venipuncture

  1 month postpartum

• 6 months postpartum Maternal fasting non-HDL

  non-HDL measured from venipuncture

  6 months postpartum

• Adverse Pregnancy Outcomes

  Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes \[GDM\], preeclampsia, hypertension)

  At Delivery

Secondary Outcomes (62)

• 1 month Infant Resting Heart Rate

  1 month

• 6 month Infant Resting Heart Rate

  6 months

• 12 month Infant Resting Heart Rate

  12 months

• 1 month Infant Resting Blood Pressure

  1 month

• 6 month Infant Resting Blood Pressure

  6 months

Study Arms (4)

Aerobic Exercise (AE)

EXPERIMENTAL

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.

Behavioral: Exercise Modes

Resistance Exercise (RE)

EXPERIMENTAL

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).

Behavioral: Exercise Modes

Combination Exercise (AERE)

EXPERIMENTAL

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.

Behavioral: Exercise Modes

Control (no exercise)

NO INTERVENTION

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

Interventions

Exercise Modes BEHAVIORAL

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

Aerobic Exercise (AE); Combination Exercise (AERE); Resistance Exercise (RE)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27834, United States

RECRUITING

Related Publications (3)

• Jevtovic F, Wisseman BL, Jahan F, Claiborne A, Collier DN, DeVente JE, Mouro S, Zeczycki T, Szumilewicz A, Adamo KB, Goodyear LJ, May LE. Maternal exercise alters placental proteome in an exercise mode-specific manner. Am J Physiol Endocrinol Metab. 2025 Dec 1;329(6):E912-E922. doi: 10.1152/ajpendo.00052.2025. Epub 2025 Nov 4.

  PMID: 41187954 DERIVED

• Jevtovic F, Claiborne A, DeVente JE, Mouro S, Houmard JA, Broskey NT, May LE. Maternal resistance exercise increases infant energy expenditure. Am J Physiol Endocrinol Metab. 2025 Mar 1;328(3):E354-E361. doi: 10.1152/ajpendo.00414.2024. Epub 2024 Dec 23.

  PMID: 39716848 DERIVED

• Jevtovic F, Collier DN, DeVente J, Mouro S, Claiborne A, Wisseman B, Steen D, Kern K, Broskey N, May LE. Maternal exercise increases infant resting energy expenditure: preliminary results. Int J Obes (Lond). 2024 Sep;48(9):1347-1350. doi: 10.1038/s41366-024-01560-0. Epub 2024 Jun 10.

  PMID: 38858465 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Linda E May, PhD

  PI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda E May, MS, PhD

CONTACT

2527377072; mayl@ecu.edu

Jameta Edwards

CONTACT

2527377156; edwardsja@ecu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: those performing measurements on participants will be blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor; Interim Dept. Chair

Model Details: PRegnant women will be randomized to one of four groups: aerobic exercise, resistance exercise, combination (aerobic + resistance), or control (no exercise). 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, 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.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 18, 2021
• Study Start: October 18, 2021
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-03

Locations

US (1)