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NCT Number: NCT06598098

MAMA Tot - Healthy Weight Parallel Study

The overall objective of this proposal is to conduct a longitudinal prospective study of healthy 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 268 healthy pregnant women randomized to an exercise intervention (aerobic exercise, resistance exercise, aerobic and resistance exercise) 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 aerobic and resistance exercise and resistance exercise training during pregnancy will, in healthy weight BMI (HW) women, improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. We will test this hypothesis with two specific aims:

Aim 1. Determine the influence of different exercise modes during HW pregnancy on infant cardiometabolic health and growth trajectories. Hypothesis: AE, RE, and AERE by HW 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, non-HDL, and C-Reactive Protein (CRP); increased insulin sensitivity) compared to infants of HW 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 HW pregnancy on improving maternal cardiometabolic health outcomes. Hypothesis: AE, RE, and AERE by HW 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 to 36 weeks gestation) and overall pregnancy outcomes (e.g. lower incidence of gestational diabetes, pre-eclampsia, hypertension during gestation) compared to HW 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 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 may be at increased risk of poor outcomes. 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.

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Key information

Conditions

Pregnancy Related

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

East Carolina University

Greenville, North Carolina, 27834, United States

Location status: Recruiting

Location contact

James DeVente, MD

CONTACT

[email protected]

Linda E May, MS, PhD

CONTACT

[email protected]

252-737-7072

Linda E May, MS, PhD

CONTACT

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 18.5 to 24.4
  • 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 measures from venipuncture

  2. 6 month Infant non-HDL

    Time frame: 6 months

    non-HDL measures from venipuncture

  3. 12 month Infant non-HDL

    Time frame: 12 months

    non-HDL measures 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: 36wks gestation

    non-HDL measured from venipuncture

  9. 1 month Maternal fasting non-HDL

    Time frame: 1 month postpartum

    non-HDL measured from venipuncture

  10. 6 month 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)

  12. 12 month Maternal fasting non-HDL

    Time frame: 12 months postpartum

    non-HDL measured from venipuncture

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

    body fat % from skinfolds

  8. 6 month infant Body Fat %

    Time frame: 6 months

    body fat % from skinfolds

  9. 12 month infant Body Fat %

    Time frame: 12 months

    body fat % from skinfolds

  10. 1 month infant % Muscle Mass

    Time frame: 1 month

    muscle mass % from skinfolds

  11. 6 month infant % Muscle Mass

    Time frame: 6 months

    muscle mass % from skinfolds

  12. 12 month infant % Muscle Mass

    Time frame: 12 months

    muscle mass % from skinfolds

  13. 1 month Infant Resting Energy Expenditure (REE)

    Time frame: 1 month

    resting REE

  14. 6 month Infant Resting Energy Expenditure (REE)

    Time frame: 6 months

    resting REE

  15. 12 month Infant Resting Energy Expenditure (REE)

    Time frame: 12 months

    resting REE

  16. 1 month Infant Neuromotor Assessment

    Time frame: 1 month

    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 months

    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 month 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: 16wks gestation

    resting HR

  35. 36wk Maternal Resting Heart Rate

    Time frame: 36wks 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. 12 month Postpartum Maternal Resting Heart Rate

    Time frame: 12 months postpartum

    resting HR

  39. 16wk Maternal Resting Blood Pressure

    Time frame: 16wks gestation

    resting BP

  40. 36wk Maternal Resting Blood Pressure

    Time frame: 36wks gestation

    resting BP

  41. 1 month Postpartum Maternal Resting Blood Pressure

    Time frame: 1 month postpartum

    resting BP

  42. 6 month Postpartum Maternal Resting Blood Pressure

    Time frame: 6 months postpartum

    resting BP

  43. 12 month Postpartum Maternal Resting Blood Pressure

    Time frame: 12 months postpartum

    resting BP

  44. Maternal Gestational Weight Gain (GWG)

    Time frame: At delivery

    Gestational Weight Gain

  45. 16wk Maternal Body Fat %

    Time frame: 16wks gestation

    estimated body fat %

  46. 36wk Maternal Body Fat %

    Time frame: 36wks gestation

    estimated body fat %

  47. 1 month Postpartum Maternal Body Fat %

    Time frame: 1 month postpartum

    estimated body fat %

  48. 6 month Postpartum Maternal Body Fat %

    Time frame: 6 months postpartum

    estimated body fat %

  49. 12 month Postpartum Maternal Body Fat %

    Time frame: 12 months postpartum

    estimated body fat %

  50. 16wk Maternal Biomarkers (CRP)

    Time frame: 16wks gestation

    Multiplex analyses of inflammatory markers (CRP)

  51. 36wk Maternal Biomarkers (CRP)

    Time frame: 36wks gestation

    Multiplex analyses of inflammatory markers (CRP)

  52. 1 month Postpartum Maternal Biomarkers (CRP)

    Time frame: 1 month postpartum

    Multiplex analyses of inflammatory markers (CRP)

  53. 6 month Postpartum Maternal Biomarkers (CRP)

    Time frame: 6 months postpartum

    Multiplex analyses of inflammatory markers (CRP)

  54. 12 month Postpartum Maternal Biomarkers (CRP)

    Time frame: 12 months postpartum

    Multiplex analyses of inflammatory markers (CRP)

  55. 16wk Maternal Biomarkers (IL6)

    Time frame: 16wks gestation

    Multiplex analyses of inflammatory markers (IL6)

  56. 36wk Maternal Biomarkers (IL6)

    Time frame: 36wks gestation

    Multiplex analyses of inflammatory markers (IL6)

  57. 1 month Postpartum Maternal Biomarkers (IL6)

    Time frame: 1 month postpartum

    Multiplex analyses of inflammatory markers (IL6)

  58. 6 month Postpartum Maternal Biomarkers (IL6)

    Time frame: 6 months postpartum

    Multiplex analyses of inflammatory markers (IL6)

  59. 12 month Postpartum Maternal Biomarkers (IL6)

    Time frame: 12 months postpartum

    Multiplex analyses of inflammatory markers (IL6)

  60. 16wks Maternal Biomarkers (adiponectin)

    Time frame: 16wks gestation

    Multiplex analyses of inflammatory markers (adiponectin)

  61. 36wks Maternal Biomarkers (adiponectin)

    Time frame: 36wks gestation

    Multiplex analyses of inflammatory markers (adiponectin)

  62. 1 month postpartum Maternal Biomarkers (adiponectin)

    Time frame: 1 month postpartum

    Multiplex analyses of inflammatory markers (adiponectin)

  63. 6 month postpartum Maternal Biomarkers (adiponectin)

    Time frame: 6 months postpartum

    Multiplex analyses of inflammatory markers (adiponectin)

  64. 12 month postpartum Maternal Biomarkers (adiponectin)

    Time frame: 12 months postpartum

    Multiplex analyses of inflammatory markers (adiponectin)

  65. 16wks Maternal Biomarkers (cortisol)

    Time frame: 16wks gestation

    Multiplex analyses of inflammatory markers (cortisol)

  66. 36wks Maternal Biomarkers (cortisol)

    Time frame: 36wks gestation

    Multiplex analyses of inflammatory markers (cortisol)

  67. 1 month Postpartum Maternal Biomarkers (cortisol)

    Time frame: 1 month postpartum

    Multiplex analyses of inflammatory markers (cortisol)

  68. 6 month Postpartum Maternal Biomarkers (cortisol)

    Time frame: 6 months postpartum

    Multiplex analyses of inflammatory markers (cortisol)

  69. 12 month Postpartum Maternal Biomarkers (cortisol)

    Time frame: 12 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]

252-737-7156

Linda E May, MS, PhD

CONTACT

[email protected]

252-737-7072

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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