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RecruitingNCT06598098Updated Sep 11, 2026

MAMA Tot - Healthy Weight Parallel Study

An interventional study of Exercise Modes in Pregnancy Related, sponsored by East Carolina University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by East Carolina University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Oct 2021, registered Sep 2024).
  • Started Oct 2021; still recruiting 5 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
268
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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. This study 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.

02

Conditions studied

  • Pregnancy Related

Keywords

  • exercise modes
  • exercise intervention
03

In context

Lead sponsor

East Carolina University is the lead sponsor of 84 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age: 18 to 40 years old
  • 18.5 to 24.4
  • Pregnancy: Singleton; ≤ 16 weeks gestation
  • Clearance by Obstetric provider for exercise

Exclusion criteria

Exclusion Criteria:

  • Age: ≤ 17.9 or ≥ 41 years of age
  • ≥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. /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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
268 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • No intervention
    Control (no exercise)

    The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.

Interventions

  • BehavioralExercise Modes

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

06

What researchers measure

Primary outcomes

  1. 1 month Infant non-HDL

    non-HDL measures from venipuncture

    Time frame: 1 month

  2. 6 month Infant non-HDL

    non-HDL measures from venipuncture

    Time frame: 6 months

  3. 12 month Infant non-HDL

    non-HDL measures from venipuncture

    Time frame: 12 months

  4. 1 month infant BMI z-score

    BMI normalized

    Time frame: 1 month

  5. 6 month infant BMI z-score

    BMI normalized

    Time frame: 6 months

  6. 12 month infant BMI z-score

    BMI normalized

    Time frame: 12 months

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

    non-HDL measured from venipuncture

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

  8. 36wk Maternal fasting non-HDL

    non-HDL measured from venipuncture

    Time frame: 36wks gestation

  9. 1 month Maternal fasting non-HDL

    non-HDL measured from venipuncture

    Time frame: 1 month postpartum

  10. 6 month Maternal fasting non-HDL

    non-HDL measured from venipuncture

    Time frame: 6 months postpartum

  11. Adverse Pregnancy Outcomes

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

    Time frame: At delivery

  12. 12 month Maternal fasting non-HDL

    non-HDL measured from venipuncture

    Time frame: 12 months postpartum

Secondary outcomes

  1. 1 month infant Resting Heart Rate

    resting HR

    Time frame: 1 month

  2. 6 month infant Resting Heart Rate

    resting HR

    Time frame: 6 months

  3. 12 month infant Resting Heart Rate

    resting HR

    Time frame: 12 months

  4. 1 month infant Resting Blood Pressure

    resting BP

    Time frame: 1 month

  5. 6 month infant Resting Blood Pressure

    resting BP

    Time frame: 6 months

  6. 12 month infant Resting Blood Pressure

    resting BP

    Time frame: 12 months

  7. 1 month infant Body Fat %

    body fat % from skinfolds

    Time frame: 1 month

  8. 6 month infant Body Fat %

    body fat % from skinfolds

    Time frame: 6 months

  9. 12 month infant Body Fat %

    body fat % from skinfolds

    Time frame: 12 months

  10. 1 month infant % Muscle Mass

    muscle mass % from skinfolds

    Time frame: 1 month

  11. 6 month infant % Muscle Mass

    muscle mass % from skinfolds

    Time frame: 6 months

  12. 12 month infant % Muscle Mass

    muscle mass % from skinfolds

    Time frame: 12 months

  13. 1 month Infant Resting Energy Expenditure (REE)

    resting REE

    Time frame: 1 month

  14. 6 month Infant Resting Energy Expenditure (REE)

    resting REE

    Time frame: 6 months

  15. 12 month Infant Resting Energy Expenditure (REE)

    resting REE

    Time frame: 12 months

  16. 1 month Infant Neuromotor Assessment

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

    Time frame: 1 month

  17. 6 month Infant Neuromotor Assessment

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

    Time frame: 6 months

  18. 12 month Infant Neuromotor Assessment

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

    Time frame: 12 months

  19. 1 month Infant Veggie Meter

    Raman Spectroscopy-Skin Carotenoid assessments

    Time frame: 1 month

  20. 6 month Infant Veggie Meter

    Raman Spectroscopy-Skin Carotenoid assessments

    Time frame: 6 months

  21. 12 month Infant Veggie Meter

    Raman Spectroscopy-Skin Carotenoid assessments

    Time frame: 12 months

  22. 1 month Infant Blood Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Time frame: 1 month

  23. 6 month Infant Blood Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Time frame: 6 months

  24. 12 month Infant Blood Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Time frame: 12 months

  25. 1 month Infant Blood Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Time frame: 1 month

  26. 6 month Infant Blood Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Time frame: 6 months

  27. 12 month Infant Blood Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Time frame: 12 months

  28. 1 month Infant Blood Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Time frame: 1 month

  29. 6 month Infant Blood Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Time frame: 6 months

  30. 12 month Infant Blood Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Time frame: 12 months

  31. 1 month Infant Metabolomics

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

    Time frame: 1 month

  32. 6 month Infant Metabolomics

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

    Time frame: 6 months

  33. 12 month Infant Metabolomics

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

    Time frame: 12 months

  34. 16wk Maternal Resting Heart Rate

    resting HR

    Time frame: 16wks gestation

  35. 36wk Maternal Resting Heart Rate

    resting HR

    Time frame: 36wks gestation

  36. 1 month Postpartum Maternal Resting Heart Rate

    resting HR

    Time frame: 1 month postpartum

  37. 6 month Postpartum Maternal Resting Heart Rate

    resting HR

    Time frame: 6 months postpartum

  38. 12 month Postpartum Maternal Resting Heart Rate

    resting HR

    Time frame: 12 months postpartum

  39. 16wk Maternal Resting Blood Pressure

    resting BP

    Time frame: 16wks gestation

  40. 36wk Maternal Resting Blood Pressure

    resting BP

    Time frame: 36wks gestation

  41. 1 month Postpartum Maternal Resting Blood Pressure

    resting BP

    Time frame: 1 month postpartum

  42. 6 month Postpartum Maternal Resting Blood Pressure

    resting BP

    Time frame: 6 months postpartum

  43. 12 month Postpartum Maternal Resting Blood Pressure

    resting BP

    Time frame: 12 months postpartum

  44. Maternal Gestational Weight Gain (GWG)

    Gestational Weight Gain

    Time frame: At delivery

  45. 16wk Maternal Body Fat %

    estimated body fat %

    Time frame: 16wks gestation

  46. 36wk Maternal Body Fat %

    estimated body fat %

    Time frame: 36wks gestation

  47. 1 month Postpartum Maternal Body Fat %

    estimated body fat %

    Time frame: 1 month postpartum

  48. 6 month Postpartum Maternal Body Fat %

    estimated body fat %

    Time frame: 6 months postpartum

  49. 12 month Postpartum Maternal Body Fat %

    estimated body fat %

    Time frame: 12 months postpartum

  50. 16wk Maternal Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Time frame: 16wks gestation

  51. 36wk Maternal Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Time frame: 36wks gestation

  52. 1 month Postpartum Maternal Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Time frame: 1 month postpartum

  53. 6 month Postpartum Maternal Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Time frame: 6 months postpartum

  54. 12 month Postpartum Maternal Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Time frame: 12 months postpartum

  55. 16wk Maternal Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Time frame: 16wks gestation

  56. 36wk Maternal Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Time frame: 36wks gestation

  57. 1 month Postpartum Maternal Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Time frame: 1 month postpartum

  58. 6 month Postpartum Maternal Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Time frame: 6 months postpartum

  59. 12 month Postpartum Maternal Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Time frame: 12 months postpartum

  60. 16wks Maternal Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Time frame: 16wks gestation

  61. 36wks Maternal Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Time frame: 36wks gestation

  62. 1 month postpartum Maternal Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Time frame: 1 month postpartum

  63. 6 month postpartum Maternal Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Time frame: 6 months postpartum

  64. 12 month postpartum Maternal Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Time frame: 12 months postpartum

  65. 16wks Maternal Biomarkers (cortisol)

    Multiplex analyses of inflammatory markers (cortisol)

    Time frame: 16wks gestation

  66. 36wks Maternal Biomarkers (cortisol)

    Multiplex analyses of inflammatory markers (cortisol)

    Time frame: 36wks gestation

  67. 1 month Postpartum Maternal Biomarkers (cortisol)

    Multiplex analyses of inflammatory markers (cortisol)

    Time frame: 1 month postpartum

  68. 6 month Postpartum Maternal Biomarkers (cortisol)

    Multiplex analyses of inflammatory markers (cortisol)

    Time frame: 6 months postpartum

  69. 12 month Postpartum Maternal Biomarkers (cortisol)

    Multiplex analyses of inflammatory markers (cortisol)

    Time frame: 12 months postpartum

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Claiborne A, Biagioni-Barton EM, Jevtovic F, McDonald S, Kern K, Strom C, Raychoudhury V, Houmard JA, May LE. Exercise during pregnancy: increased oxygen uptake and metabolic demand. J Appl Physiol (1985). 2026 Sep 1;141(3):920-926. doi: 10.1152/japplphysiol.00536.2026. Epub 2026 Aug 24. PubMed 42636143 ↗

Individual participant data

Plan to share: Undecided — de-identified data can be shared upon request to researchers

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06598098
Lead sponsor
East Carolina University
Responsible party
Linda May (Associate Professor; Dept. Chair, East Carolina University) — Principal investigator
First posted
Sep 19, 2024
Start date
Oct 18, 2021
Primary completion
Jan 30, 2027 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
Sep 11, 2026

Study contacts

Linda E May, MS, PhD
Contact
mayl@ecu.edu
252-737-7072
Jameta Edwards
Contact
edwardsja@ecu.edu
252-737-7156
Linda May, MS, PhD
principal investigator · East Carolina University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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