Pregnancy Exercise Mode Effect on Childhood Obesity

Sponsor

East Carolina University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04805502

Collaborator

(none)

300

Enrollment

Location

Arms

70.4

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Overweight and Obesity	Behavioral: Exercise Modes	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description:

those performing measurements on participants will be blinded to group allocation.

Primary Purpose:

Prevention

Official Title:

Effect of Exercise Modality During Pregnancy on Childhood Obesity Risk

Actual Study Start Date :

Oct 18, 2021

Anticipated Primary Completion Date :

Jan 30, 2027

Anticipated Study Completion Date :

Aug 30, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1 month Infant non-HDL [1 month]
non-HDL measured from venipuncture
6 month Infant non-HDL [6 months]
non-HDL measured from venipuncture
12 month Infant non-HDL [12 months]
non-HDL measured from venipuncture
1 month Infant BMI z-score [1 month]
BMI normalized
6 month Infant BMI z-score [6 months]
BMI normalized
12 month Infant BMI z-score [12 months]
BMI normalized
Enrollment (8-13wks) Maternal fasting non-HDL [enrollment (~8-13 wks gestation)]
non-HDL measured from venipuncture
36wk Maternal fasting non-HDL [36 weeks gestation]
non-HDL measured from venipuncture
1 month postpartum Maternal fasting non-HDL [1 month postpartum]
non-HDL measured from venipuncture
6 months postpartum Maternal fasting non-HDL [6 months postpartum]
non-HDL measured from venipuncture
Adverse Pregnancy Outcomes [At Delivery]
Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes [GDM], preeclampsia, hypertension)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Carolina University	Greenville	North Carolina	United States	27834

Sponsors and Collaborators

East Carolina University

Investigators

Principal Investigator: Linda E May, PhD, PI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Linda May, Associate Professor; Interim Dept. Chair, East Carolina University

ClinicalTrials.gov Identifier:

NCT04805502

Other Study ID Numbers:

19-001863

First Posted:

Mar 18, 2021

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Linda May, Associate Professor; Interim Dept. Chair, East Carolina University

exercise modes, exercise intervention

Additional relevant MeSH terms:

Obesity

Pediatric Obesity

Overweight

Study Results

No Results Posted as of Jul 19, 2022