Pregnancy Exercise Mode Effect on Childhood Obesity

Pregnancy Clinical Trial

Official title:

Effect of Exercise Modality During Pregnancy on Childhood Obesity Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04805502
• Other study ID #: 19-001863
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: August 30, 2027

Study information

• Verified date: August 2023
• Source: East Carolina University
• Contact: Linda E May, MS, PhD
• Phone: 2527377072
• Email: mayl[@]ecu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 30, 2027
• Est. primary completion date: January 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity
• Pediatric Obesity
• Pregnancy

Intervention

Behavioral:
• Exercise Modes
Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise

Locations

Country	Name	City	State
United States	East Carolina University	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 month Infant non-HDL	non-HDL measured from venipuncture	1 month
Primary	6 month Infant non-HDL	non-HDL measured from venipuncture	6 months
Primary	12 month Infant non-HDL	non-HDL measured from venipuncture	12 months
Primary	1 month Infant BMI z-score	BMI normalized	1 month
Primary	6 month Infant BMI z-score	BMI normalized	6 months
Primary	12 month Infant BMI z-score	BMI normalized	12 months
Primary	Enrollment (8-13wks) Maternal fasting non-HDL	non-HDL measured from venipuncture	enrollment (~8-13 wks gestation)
Primary	36wk Maternal fasting non-HDL	non-HDL measured from venipuncture	36 weeks gestation
Primary	1 month postpartum Maternal fasting non-HDL	non-HDL measured from venipuncture	1 month postpartum
Primary	6 months postpartum Maternal fasting non-HDL	non-HDL measured from venipuncture	6 months postpartum
Primary	Adverse Pregnancy Outcomes	Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes [GDM], preeclampsia, hypertension)	At Delivery
Secondary	1 month Infant Resting Heart Rate	resting HR	1 month
Secondary	6 month Infant Resting Heart Rate	resting HR	6 months
Secondary	12 month Infant Resting Heart Rate	resting HR	12 months
Secondary	1 month Infant Resting Blood Pressure	resting BP	1 month
Secondary	6 month Infant Resting Blood Pressure	resting BP	6 months
Secondary	12 month Infant Resting Blood Pressure	resting BP	12 months
Secondary	1 month Infant Body Fat %	estimated body fat % from skinfolds	1 month
Secondary	6 month Infant Body Fat %	estimated body fat % from skinfolds	6 months
Secondary	12 month Infant Body Fat %	estimated body fat % from skinfolds	12 months
Secondary	1 month Infant % Muscle Mass	estimated muscle mass % from skinfolds	1 months
Secondary	6 month Infant % Muscle Mass	estimated muscle mass % from skinfolds	6 months
Secondary	12 month Infant % Muscle Mass	estimated muscle mass % from skinfolds	12 months
Secondary	1 month Infant Resting Energy Expenditure (REE)	estimated REE	1 months
Secondary	6 month Infant Resting Energy Expenditure (REE)	estimated resting energy expenditure	6 months
Secondary	12 month Infant Resting Energy Expenditure (REE)	estimated resting energy expenditure	12 months
Secondary	1 month Infant Neuromotor Assessment	Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better	1 months
Secondary	6 month Infant Neuromotor Assessment	Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better	6 months
Secondary	12 month Infant Neuromotor Assessment	Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better	12 months
Secondary	1 month Infant Veggie Meter	Raman Spectroscopy-Skin Carotenoid assessments	1 month
Secondary	6 month Infant Veggie Meter	Raman spectroscopy-Skin Carotenoid assessments	6 months
Secondary	12 month Infant Veggie Meter	Raman spectroscopy-Skin Carotenoid assessments	12 months
Secondary	1 month Infant Blood Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	1 month
Secondary	6 month Infant Blood Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	6 months
Secondary	12 month Infant Blood Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	12 months
Secondary	1 month Infant Blood Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	1 month
Secondary	6 month Infant Blood Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	6 months
Secondary	12 month Infant Blood Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	12 months
Secondary	1 month Infant Blood Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	1 month
Secondary	6 month Infant Blood Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	6 month
Secondary	12 month Infant Blood Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	16wk Maternal Resting Heart Rate	resting HR	16 gestation
Secondary	36wk Maternal Resting Heart Rate	resting HR	36 weeks gestation
Secondary	1 month postpartum Maternal Resting Heart Rate	resting HR	1 month postpartum
Secondary	6 month postpartum Maternal Resting Heart Rate	resting HR	6 months postpartum
Secondary	16wk Maternal Resting Blood Pressure	resting BP	16 weeks gestation
Secondary	36wk Maternal Resting Blood Pressure	resting BP	36 weeks gestation
Secondary	1 month postpartum Maternal Resting Blood Pressure	resting BP	1 month postpartum
Secondary	6 month postpartum Maternal Resting Blood Pressure	resting BP	6 months postpartum
Secondary	Maternal Gestational Weight Gain (GWG)	Gestational Weight Gain	at delivery
Secondary	16wk Maternal Body Fat%	Estimated body fat %	16 weeks gestation
Secondary	36wk Maternal Body Fat%	Estimated body fat %	36 weeks gestation
Secondary	1 month Postpartum Maternal Body Fat%	Estimated body fat %	1 month postpartum
Secondary	6 month Postpartum Maternal Body Fat%	Estimated body fat %	6 months postpartum
Secondary	16wk Maternal Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	16 weeks gestation
Secondary	36wk Maternal Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	36 weeks gestation
Secondary	1 month postpartum Maternal Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	1 month postpartum
Secondary	6 month Postpartum Maternal Biomarkers (CRP)	Multiplex analyses of inflammatory markers (CRP)	6 months postpartum
Secondary	16wk Maternal Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	16 weeks gestation
Secondary	36wk Maternal Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	36 weeks gestation
Secondary	1 month Postpartum Maternal Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	1 month postpartum
Secondary	6 month Postpartum Maternal Biomarkers (IL6)	Multiplex analyses of inflammatory markers (IL6)	6 months postpartum
Secondary	16wk Maternal Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	16 weeks gestation
Secondary	36wk Maternal Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	36 weeks gestation
Secondary	1 month Postpartum Maternal Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	1 month postpartum
Secondary	6 month Postpartum Maternal Biomarkers (adiponectin)	Multiplex analyses of inflammatory markers (adiponectin)	6 months postpartum
Secondary	16wk Maternal Biomarkers (cortisol)	Multiplex analyses of inflammatory markers (cortisol)	16 weeks gestation
Secondary	36wk Maternal Biomarkers (cortisol)	Multiplex analyses of inflammatory markers (cortisol)	36 weeks gestation
Secondary	1 month Postpartum Maternal Biomarkers (cortisol)	Multiplex analyses of inflammatory markers (cortisol)	1 month postpartum
Secondary	6 month Postpartum Maternal Biomarkers (cortisol)	Multiplex analyses of inflammatory markers (cortisol)	6 months postpartum