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NCT Number: NCT04805502

Pregnancy Exercise Mode Effect on Childhood Obesity

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Modes

Behavioral

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

Primary outcomes

  1. 1 month Infant non-HDL

    Time frame: 1 month

    non-HDL measured from venipuncture

  2. 6 month Infant non-HDL

    Time frame: 6 months

    non-HDL measured from venipuncture

  3. 12 month Infant non-HDL

    Time frame: 12 months

    non-HDL measured from venipuncture

  4. 1 month Infant BMI z-score

    Time frame: 1 month

    BMI normalized

  5. 6 month Infant BMI z-score

    Time frame: 6 months

    BMI normalized

  6. 12 month Infant BMI z-score

    Time frame: 12 months

    BMI normalized

  7. Enrollment (8-13wks) Maternal fasting non-HDL

    Time frame: enrollment (~8-13 wks gestation)

    non-HDL measured from venipuncture

  8. 36wk Maternal fasting non-HDL

    Time frame: 36 weeks gestation

    non-HDL measured from venipuncture

  9. 1 month postpartum Maternal fasting non-HDL

    Time frame: 1 month postpartum

    non-HDL measured from venipuncture

  10. 6 months postpartum Maternal fasting non-HDL

    Time frame: 6 months postpartum

    non-HDL measured from venipuncture

  11. Adverse Pregnancy Outcomes

    Time frame: At Delivery

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

Secondary outcomes

  1. 1 month Infant Resting Heart Rate

    Time frame: 1 month

    resting HR

  2. 6 month Infant Resting Heart Rate

    Time frame: 6 months

    resting HR

  3. 12 month Infant Resting Heart Rate

    Time frame: 12 months

    resting HR

  4. 1 month Infant Resting Blood Pressure

    Time frame: 1 month

    resting BP

  5. 6 month Infant Resting Blood Pressure

    Time frame: 6 months

    resting BP

  6. 12 month Infant Resting Blood Pressure

    Time frame: 12 months

    resting BP

  7. 1 month Infant Body Fat %

    Time frame: 1 month

    estimated body fat % from skinfolds

  8. 6 month Infant Body Fat %

    Time frame: 6 months

    estimated body fat % from skinfolds

  9. 12 month Infant Body Fat %

    Time frame: 12 months

    estimated body fat % from skinfolds

  10. 1 month Infant % Muscle Mass

    Time frame: 1 months

    estimated muscle mass % from skinfolds

  11. 6 month Infant % Muscle Mass

    Time frame: 6 months

    estimated muscle mass % from skinfolds

  12. 12 month Infant % Muscle Mass

    Time frame: 12 months

    estimated muscle mass % from skinfolds

  13. 1 month Infant Resting Energy Expenditure (REE)

    Time frame: 1 months

    estimated REE

  14. 6 month Infant Resting Energy Expenditure (REE)

    Time frame: 6 months

    estimated resting energy expenditure

  15. 12 month Infant Resting Energy Expenditure (REE)

    Time frame: 12 months

    estimated resting energy expenditure

  16. 1 month Infant Neuromotor Assessment

    Time frame: 1 months

    Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better

  17. 6 month Infant Neuromotor Assessment

    Time frame: 6 months

    Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better

  18. 12 month Infant Neuromotor Assessment

    Time frame: 12 months

    Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better

  19. 1 month Infant Veggie Meter

    Time frame: 1 month

    Raman Spectroscopy-Skin Carotenoid assessments

  20. 6 month Infant Veggie Meter

    Time frame: 6 months

    Raman spectroscopy-Skin Carotenoid assessments

  21. 12 month Infant Veggie Meter

    Time frame: 12 months

    Raman spectroscopy-Skin Carotenoid assessments

  22. 1 month Infant Blood Biomarkers (CRP)

    Time frame: 1 month

    Multiplex analyses of inflammatory markers (CRP)

  23. 6 month Infant Blood Biomarkers (CRP)

    Time frame: 6 months

    Multiplex analyses of inflammatory markers (CRP)

  24. 12 month Infant Blood Biomarkers (CRP)

    Time frame: 12 months

    Multiplex analyses of inflammatory markers (CRP)

  25. 1 month Infant Blood Biomarkers (IL6)

    Time frame: 1 month

    Multiplex analyses of inflammatory markers (IL6)

  26. 6 month Infant Blood Biomarkers (IL6)

    Time frame: 6 months

    Multiplex analyses of inflammatory markers (IL6)

  27. 12 month Infant Blood Biomarkers (IL6)

    Time frame: 12 months

    Multiplex analyses of inflammatory markers (IL6)

  28. 1 month Infant Blood Biomarkers (adiponectin)

    Time frame: 1 month

    Multiplex analyses of inflammatory markers (adiponectin)

  29. 6 month Infant Blood Biomarkers (adiponectin)

    Time frame: 6 month

    Multiplex analyses of inflammatory markers (adiponectin)

  30. 12 month Infant Blood Biomarkers (adiponectin)

    Time frame: 12 months

    Multiplex analyses of inflammatory markers (adiponectin)

  31. 1 month Infant Metabolomics

    Time frame: 1 month

    Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05

  32. 6 month Infant Metabolomics

    Time frame: 6 months

    Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05

  33. 12 months Infant Metabolomics

    Time frame: 12 months

    Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05

  34. 16wk Maternal Resting Heart Rate

    Time frame: 16 gestation

    resting HR

  35. 36wk Maternal Resting Heart Rate

    Time frame: 36 weeks gestation

    resting HR

  36. 1 month postpartum Maternal Resting Heart Rate

    Time frame: 1 month postpartum

    resting HR

  37. 6 month postpartum Maternal Resting Heart Rate

    Time frame: 6 months postpartum

    resting HR

  38. 16wk Maternal Resting Blood Pressure

    Time frame: 16 weeks gestation

    resting BP

  39. 36wk Maternal Resting Blood Pressure

    Time frame: 36 weeks gestation

    resting BP

  40. 1 month postpartum Maternal Resting Blood Pressure

    Time frame: 1 month postpartum

    resting BP

  41. 6 month postpartum Maternal Resting Blood Pressure

    Time frame: 6 months postpartum

    resting BP

  42. Maternal Gestational Weight Gain (GWG)

    Time frame: at delivery

    Gestational Weight Gain

  43. 16wk Maternal Body Fat%

    Time frame: 16 weeks gestation

    Estimated body fat %

  44. 36wk Maternal Body Fat%

    Time frame: 36 weeks gestation

    Estimated body fat %

  45. 1 month Postpartum Maternal Body Fat%

    Time frame: 1 month postpartum

    Estimated body fat %

  46. 6 month Postpartum Maternal Body Fat%

    Time frame: 6 months postpartum

    Estimated body fat %

  47. 16wk Maternal Biomarkers (CRP)

    Time frame: 16 weeks gestation

    Multiplex analyses of inflammatory markers (CRP)

  48. 36wk Maternal Biomarkers (CRP)

    Time frame: 36 weeks gestation

    Multiplex analyses of inflammatory markers (CRP)

  49. 1 month postpartum Maternal Biomarkers (CRP)

    Time frame: 1 month postpartum

    Multiplex analyses of inflammatory markers (CRP)

  50. 6 month Postpartum Maternal Biomarkers (CRP)

    Time frame: 6 months postpartum

    Multiplex analyses of inflammatory markers (CRP)

  51. 16wk Maternal Biomarkers (IL6)

    Time frame: 16 weeks gestation

    Multiplex analyses of inflammatory markers (IL6)

  52. 36wk Maternal Biomarkers (IL6)

    Time frame: 36 weeks gestation

    Multiplex analyses of inflammatory markers (IL6)

  53. 1 month Postpartum Maternal Biomarkers (IL6)

    Time frame: 1 month postpartum

    Multiplex analyses of inflammatory markers (IL6)

  54. 6 month Postpartum Maternal Biomarkers (IL6)

    Time frame: 6 months postpartum

    Multiplex analyses of inflammatory markers (IL6)

  55. 16wk Maternal Biomarkers (adiponectin)

    Time frame: 16 weeks gestation

    Multiplex analyses of inflammatory markers (adiponectin)

  56. 36wk Maternal Biomarkers (adiponectin)

    Time frame: 36 weeks gestation

    Multiplex analyses of inflammatory markers (adiponectin)

  57. 1 month Postpartum Maternal Biomarkers (adiponectin)

    Time frame: 1 month postpartum

    Multiplex analyses of inflammatory markers (adiponectin)

  58. 6 month Postpartum Maternal Biomarkers (adiponectin)

    Time frame: 6 months postpartum

    Multiplex analyses of inflammatory markers (adiponectin)

  59. 16wk Maternal Biomarkers (cortisol)

    Time frame: 16 weeks gestation

    Multiplex analyses of inflammatory markers (cortisol)

  60. 36wk Maternal Biomarkers (cortisol)

    Time frame: 36 weeks gestation

    Multiplex analyses of inflammatory markers (cortisol)

  61. 1 month Postpartum Maternal Biomarkers (cortisol)

    Time frame: 1 month postpartum

    Multiplex analyses of inflammatory markers (cortisol)

  62. 6 month Postpartum Maternal Biomarkers (cortisol)

    Time frame: 6 months postpartum

    Multiplex analyses of inflammatory markers (cortisol)

Study contacts

Contact information is provided by the study sponsor or research team.

Jameta Edwards

CONTACT

[email protected]

2527377156

Linda E May, MS, PhD

CONTACT

[email protected]

2527377072

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Registry information

Official study title

Effect of Exercise Modality During Pregnancy on Childhood Obesity Risk

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2021
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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