Pregnancy Exercise Mode Effect on Childhood Obesity

Effect of Exercise Modality During Pregnancy on Childhood Obesity Risk

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Overweight and Obesity
• Intervention / Treatment: Behavioral: Exercise Modes

Detailed Description

Many public health initiatives in the United States, including Healthy People 2020, have goals that include reducing obesity (OB), metabolic dysfunction, and risk of cardiovascular disease (CVD). Studies such as the Bogalusa project have now demonstrated that overweightness (OW), beginning as early as age five, is predictive of adult CVD. In fact, the onset of OW/OB and CVD may begin in the intrauterine period, and infant birth weight and weight gain are strongly related to OB in childhood and beyond. OW/OB mothers and their offspring exhibit increased morbidity and mortality; the American College of Obstetricians and Gynecologists (ACOG) has developed guidelines geared toward reducing maternal OW/OB through exercise. However, few studies have focused on how such exercise interventions during pregnancy impact short and long-term child health outcomes. Furthermore, little is known regarding the influence of different modes of antenatal exercise upon maternal and offspring health outcomes.

The long-term goal of this study is to attenuate child- and adulthood OB and CVD risk by identifying the most effective and easily implemented maternal exercise interventions. The investigators have shown that maternal aerobic exercise (AE) in women of all BMIs favorably impacts maternal cholesterol and LDL levels, which are predictive of infant weight. Furthermore, maternal AE is associated with decreased fetal abdominal circumference (AC), lower body fat percentage at one month, and improved infant neuromotor skills. Our preliminary data for pregnant women of all BMIs suggests that resistance exercise (RE) confers similar benefits to infants at one month as compared to AE, plus improvements such as decreased BMI z-scores, increased metabolomic signatures for glucose use, and decreased metabolites of inflammatory pathways. The most striking finding from this preliminary work is that adding RE to AE improved outcomes for both mothers and infants. Thus, the COMBINATION of aerobic and resistance exercise (AERE) not only had better maternal and one month infant outcomes (versus AE alone), but AERE groups had the best compliance. The positive changes were most pronounced in the infants of OW/OB women. A more comprehensive, longitudinal study geared toward OW/OB mothers is needed to confirm our preliminary work and to assess the persistence of exercise impacts through the infants' first year of life.

The overall objective of this proposal is to conduct a longitudinal prospective study of OW/OB pregnant women and their offspring to determine which antenatal maternal exercise mode(s) will have the greatest impact on maternal and infant cardiometabolic health. This information may lead to modified clinical practice recommendations that improve health in childhood and possibly beyond. This randomized controlled trial will recruit 284 OW/OB pregnant women randomized to an exercise intervention (AE, RE, AERE) or to no exercise (usual care); their infants will be measured at 1, 6, and 12 months of age. This rigorous design will test our central hypothesis that AERE and RE exercise training during pregnancy will, in OW/OB women, improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. The investigators will test this hypothesis 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 BMI z-score, body fat %, non-HDL, heart rate, 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, body fat %, HR, non-HDL, weight gain) across pregnancy (~13 to ~40 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 with improved health outcomes.

The proposed innovative study will be the first to provide a critical understanding of the influence of antenatal exercise modes upon 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 and CVD, potentially providing the earliest and most efficacious intervention to attenuate or prevent OB and CVD in the next generation.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda E May, MS, PhD; Phone Number: 2527377072; Email: mayl@ecu.edu
• Study Contact Backup: Name: Jameta Edwards; Phone Number: 2527377156; Email: edwardsja@ecu.edu

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Recruiting
      • East Carolina University
      • Contact: Linda E May, MS, PhD; Phone Number: 252-737-7072; Email: mayl@ecu.edu
      • Contact: James DeVente, MD; Email: deventeja@ecu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Exercise Modes; Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise
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).	Behavioral: Exercise Modes; Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise
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.	Behavioral: Exercise Modes; Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise
No Intervention: Control (no exercise); The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 month Infant Resting Heart Rate	resting HR	1 month
6 month Infant Resting Heart Rate	resting HR	6 months
12 month Infant Resting Heart Rate	resting HR	12 months
1 month Infant Resting Blood Pressure	resting BP	1 month
6 month Infant Resting Blood Pressure	resting BP	6 months
12 month Infant Resting Blood Pressure	resting BP	12 months
1 month Infant Body Fat %	estimated body fat % from skinfolds	1 month
6 month Infant Body Fat %	estimated body fat % from skinfolds	6 months
12 month Infant Body Fat %	estimated body fat % from skinfolds	12 months
1 month Infant % Muscle Mass	estimated muscle mass % from skinfolds	1 months
6 month Infant % Muscle Mass	estimated muscle mass % from skinfolds	6 months
12 month Infant % Muscle Mass	estimated muscle mass % from skinfolds	12 months
1 month Infant Resting Energy Expenditure (REE)	estimated REE	1 months
6 month Infant Resting Energy Expenditure (REE)	estimated resting energy expenditure	6 months
12 month Infant Resting Energy Expenditure (REE)	estimated resting energy expenditure	12 months
1 month Infant Neuromotor Assessment	Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better	1 months
6 month Infant Neuromotor Assessment	Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better	6 months
12 month Infant Neuromotor Assessment	Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better	12 months
1 month Infant Veggie Meter	Raman Spectroscopy-Skin Carotenoid assessments	1 month
6 month Infant Veggie Meter	Raman spectroscopy-Skin Carotenoid assessments	6 months
12 month Infant Veggie Meter	Raman spectroscopy-Skin Carotenoid assessments	12 months
1 month Infant Blood Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	1 month
6 month Infant Blood Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	6 months
12 month Infant Blood Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	12 months
1 month Infant Blood Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	1 month
6 month Infant Blood Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	6 months
12 month Infant Blood Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	12 months
1 month Infant Blood Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	1 month
6 month Infant Blood Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	6 month
12 month Infant Blood Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	12 months
1 month Infant Metabolomics	Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05	1 month
6 month Infant Metabolomics	Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05	6 months
12 months Infant Metabolomics	Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05	12 months
16wk Maternal Resting Heart Rate	resting HR	16 gestation
36wk Maternal Resting Heart Rate	resting HR	36 weeks gestation
1 month postpartum Maternal Resting Heart Rate	resting HR	1 month postpartum
6 month postpartum Maternal Resting Heart Rate	resting HR	6 months postpartum
16wk Maternal Resting Blood Pressure	resting BP	16 weeks gestation
36wk Maternal Resting Blood Pressure	resting BP	36 weeks gestation
1 month postpartum Maternal Resting Blood Pressure	resting BP	1 month postpartum
6 month postpartum Maternal Resting Blood Pressure	resting BP	6 months postpartum
Maternal Gestational Weight Gain (GWG)	Gestational Weight Gain	at delivery
16wk Maternal Body Fat%	Estimated body fat %	16 weeks gestation
36wk Maternal Body Fat%	Estimated body fat %	36 weeks gestation
1 month Postpartum Maternal Body Fat%	Estimated body fat %	1 month postpartum
6 month Postpartum Maternal Body Fat%	Estimated body fat %	6 months postpartum
16wk Maternal Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	16 weeks gestation
36wk Maternal Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	36 weeks gestation
1 month postpartum Maternal Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	1 month postpartum
6 month Postpartum Maternal Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	6 months postpartum
16wk Maternal Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	16 weeks gestation
36wk Maternal Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	36 weeks gestation
1 month Postpartum Maternal Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	1 month postpartum
6 month Postpartum Maternal Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	6 months postpartum
16wk Maternal Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	16 weeks gestation
36wk Maternal Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	36 weeks gestation
1 month Postpartum Maternal Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	1 month postpartum
6 month Postpartum Maternal Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	6 months postpartum
16wk Maternal Biomarkers (cortisol)	Multiplex analyses of inflammatory markers (cortisol)	16 weeks gestation
36wk Maternal Biomarkers (cortisol)	Multiplex analyses of inflammatory markers (cortisol)	36 weeks gestation
1 month Postpartum Maternal Biomarkers (cortisol)	Multiplex analyses of inflammatory markers (cortisol)	1 month postpartum
6 month Postpartum Maternal Biomarkers (cortisol)	Multiplex analyses of inflammatory markers (cortisol)	6 months postpartum

Collaborators and Investigators

• Sponsor: East Carolina University
• Investigators: Principal Investigator: Linda E May, PhD, PI

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 5, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: exercise modes, exercise intervention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Pediatric Obesity; Overweight
• Other Study ID Numbers: 19-001863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: de-identified data can be shared upon request to researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No