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PregnancyNCT04805502

Pregnancy Exercise Mode Effect on Childhood Obesity

A study testing Exercise Modes in people with Pregnancy and Overweight and Obesity, run by East Carolina University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Overweight and Obesity
What is being tested?
Exercise Modes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
18 Oct 2021to 30 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age: 18 to 40 years old
  • BMI between ≥ 25
  • Pregnancy: Singleton; ≤ 16 weeks gestation
  • Clearance by Obstetric provider for exercise

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Linda E May, MS, PhD contact

2527377072

mayl@ecu.edu

Jameta Edwards contact

2527377156

edwardsja@ecu.edu

United States1 site, 1 recruiting
  • East Carolina University

    Greenville, North Carolina, 27834

    Linda E May, MS, PhD, 2527377072, mayl@ecu.edu

    James DeVente, MD, deventeja@ecu.edu

    Recruiting

Other trials in United States

About this study

Official title: Effect of Exercise Modality During Pregnancy on Childhood Obesity Risk

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.

Read more

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.

Read the 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.

Being tested
Exercise Modes
Keywords
exercise modes, exercise intervention
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise ModesBehavioural

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

Study groups in NCT04805502
Study groupRoleWhat they receive
Aerobic Exercise (AE)ExperimentalAll 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.
Receives: Behavioral: Exercise Modes
Resistance Exercise (RE)ExperimentalAll 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).
Receives: Behavioral: Exercise Modes
Combination Exercise (AERE)ExperimentalAll 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.
Receives: Behavioral: Exercise Modes
Control (no exercise)No interventionThe Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1 month Infant non-HDL

    non-HDL measured from venipuncture

    Measured: 1 month

  2. 6 month Infant non-HDL

    non-HDL measured from venipuncture

    Measured: 6 months

  3. 12 month Infant non-HDL

    non-HDL measured from venipuncture

    Measured: 12 months

  4. 1 month Infant BMI z-score

    BMI normalized

    Measured: 1 month

  5. 6 month Infant BMI z-score

    BMI normalized

    Measured: 6 months

  6. 12 month Infant BMI z-score

    BMI normalized

    Measured: 12 months

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

    non-HDL measured from venipuncture

    Measured: enrollment (~8-13 wks gestation)

  8. 36wk Maternal fasting non-HDL

    non-HDL measured from venipuncture

    Measured: 36 weeks gestation

  9. 1 month postpartum Maternal fasting non-HDL

    non-HDL measured from venipuncture

    Measured: 1 month postpartum

  10. 6 months postpartum Maternal fasting non-HDL

    non-HDL measured from venipuncture

    Measured: 6 months postpartum

  11. Adverse Pregnancy Outcomes

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

    Measured: At Delivery

Secondary outcomes (62)
  1. 1 month Infant Resting Heart Rate

    resting HR

    Measured: 1 month

  2. 6 month Infant Resting Heart Rate

    resting HR

    Measured: 6 months

  3. 12 month Infant Resting Heart Rate

    resting HR

    Measured: 12 months

  4. 1 month Infant Resting Blood Pressure

    resting BP

    Measured: 1 month

  5. 6 month Infant Resting Blood Pressure

    resting BP

    Measured: 6 months

  6. 12 month Infant Resting Blood Pressure

    resting BP

    Measured: 12 months

  7. 1 month Infant Body Fat %

    estimated body fat % from skinfolds

    Measured: 1 month

  8. 6 month Infant Body Fat %

    estimated body fat % from skinfolds

    Measured: 6 months

  9. 12 month Infant Body Fat %

    estimated body fat % from skinfolds

    Measured: 12 months

  10. 1 month Infant % Muscle Mass

    estimated muscle mass % from skinfolds

    Measured: 1 months

  11. 6 month Infant % Muscle Mass

    estimated muscle mass % from skinfolds

    Measured: 6 months

  12. 12 month Infant % Muscle Mass

    estimated muscle mass % from skinfolds

    Measured: 12 months

  13. 1 month Infant Resting Energy Expenditure (REE)

    estimated REE

    Measured: 1 months

  14. 6 month Infant Resting Energy Expenditure (REE)

    estimated resting energy expenditure

    Measured: 6 months

  15. 12 month Infant Resting Energy Expenditure (REE)

    estimated resting energy expenditure

    Measured: 12 months

  16. 1 month Infant Neuromotor Assessment

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

    Measured: 1 months

  17. 6 month Infant Neuromotor Assessment

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

    Measured: 6 months

  18. 12 month Infant Neuromotor Assessment

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

    Measured: 12 months

  19. 1 month Infant Veggie Meter

    Raman Spectroscopy-Skin Carotenoid assessments

    Measured: 1 month

  20. 6 month Infant Veggie Meter

    Raman spectroscopy-Skin Carotenoid assessments

    Measured: 6 months

  21. 12 month Infant Veggie Meter

    Raman spectroscopy-Skin Carotenoid assessments

    Measured: 12 months

  22. 1 month Infant Blood Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Measured: 1 month

  23. 6 month Infant Blood Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Measured: 6 months

  24. 12 month Infant Blood Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Measured: 12 months

  25. 1 month Infant Blood Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Measured: 1 month

  26. 6 month Infant Blood Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Measured: 6 months

  27. 12 month Infant Blood Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Measured: 12 months

  28. 1 month Infant Blood Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Measured: 1 month

  29. 6 month Infant Blood Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Measured: 6 month

  30. 12 month Infant Blood Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Measured: 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

    Measured: 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

    Measured: 6 months

  33. 12 months Infant Metabolomics

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

    Measured: 12 months

  34. 16wk Maternal Resting Heart Rate

    resting HR

    Measured: 16 gestation

  35. 36wk Maternal Resting Heart Rate

    resting HR

    Measured: 36 weeks gestation

  36. 1 month postpartum Maternal Resting Heart Rate

    resting HR

    Measured: 1 month postpartum

  37. 6 month postpartum Maternal Resting Heart Rate

    resting HR

    Measured: 6 months postpartum

  38. 16wk Maternal Resting Blood Pressure

    resting BP

    Measured: 16 weeks gestation

  39. 36wk Maternal Resting Blood Pressure

    resting BP

    Measured: 36 weeks gestation

  40. 1 month postpartum Maternal Resting Blood Pressure

    resting BP

    Measured: 1 month postpartum

  41. 6 month postpartum Maternal Resting Blood Pressure

    resting BP

    Measured: 6 months postpartum

  42. Maternal Gestational Weight Gain (GWG)

    Gestational Weight Gain

    Measured: at delivery

  43. 16wk Maternal Body Fat%

    Estimated body fat %

    Measured: 16 weeks gestation

  44. 36wk Maternal Body Fat%

    Estimated body fat %

    Measured: 36 weeks gestation

  45. 1 month Postpartum Maternal Body Fat%

    Estimated body fat %

    Measured: 1 month postpartum

  46. 6 month Postpartum Maternal Body Fat%

    Estimated body fat %

    Measured: 6 months postpartum

  47. 16wk Maternal Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Measured: 16 weeks gestation

  48. 36wk Maternal Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Measured: 36 weeks gestation

  49. 1 month postpartum Maternal Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Measured: 1 month postpartum

  50. 6 month Postpartum Maternal Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Measured: 6 months postpartum

  51. 16wk Maternal Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Measured: 16 weeks gestation

  52. 36wk Maternal Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Measured: 36 weeks gestation

  53. 1 month Postpartum Maternal Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Measured: 1 month postpartum

  54. 6 month Postpartum Maternal Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Measured: 6 months postpartum

  55. 16wk Maternal Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Measured: 16 weeks gestation

  56. 36wk Maternal Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Measured: 36 weeks gestation

  57. 1 month Postpartum Maternal Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Measured: 1 month postpartum

  58. 6 month Postpartum Maternal Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Measured: 6 months postpartum

  59. 16wk Maternal Biomarkers (cortisol)

    Multiplex analyses of inflammatory markers (cortisol)

    Measured: 16 weeks gestation

  60. 36wk Maternal Biomarkers (cortisol)

    Multiplex analyses of inflammatory markers (cortisol)

    Measured: 36 weeks gestation

  61. 1 month Postpartum Maternal Biomarkers (cortisol)

    Multiplex analyses of inflammatory markers (cortisol)

    Measured: 1 month postpartum

  62. 6 month Postpartum Maternal Biomarkers (cortisol)

    Multiplex analyses of inflammatory markers (cortisol)

    Measured: 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start18 Oct 2021
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04805502
Sponsor's protocol ID
19-001863
Status last verified
Mar 2026
First submitted
3 Mar 2021
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: de-identified data can be shared upon request to researchers

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
  • Jevtovic F, Wisseman BL, Jahan F, Claiborne A, Collier DN, DeVente JE, Mouro S, Zeczycki T, Szumilewicz A, Adamo KB, Goodyear LJ, May LE. Maternal exercise alters placental proteome in an exercise mode-specific manner. Am J Physiol Endocrinol Metab. 2025 Dec 1;329(6):E912-E922. doi: 10.1152/ajpendo.00052.2025. Epub 2025 Nov 4.

    PubMed 41187954
  • Jevtovic F, Claiborne A, DeVente JE, Mouro S, Houmard JA, Broskey NT, May LE. Maternal resistance exercise increases infant energy expenditure. Am J Physiol Endocrinol Metab. 2025 Mar 1;328(3):E354-E361. doi: 10.1152/ajpendo.00414.2024. Epub 2024 Dec 23.

    PubMed 39716848
  • Jevtovic F, Collier DN, DeVente J, Mouro S, Claiborne A, Wisseman B, Steen D, Kern K, Broskey N, May LE. Maternal exercise increases infant resting energy expenditure: preliminary results. Int J Obes (Lond). 2024 Sep;48(9):1347-1350. doi: 10.1038/s41366-024-01560-0. Epub 2024 Jun 10.

    PubMed 38858465

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Modes in people with Pregnancy and Overweight and Obesity, run by East Carolina University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Linda E May, MS, PhD (2527377072, mayl@ecu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1 month Infant non-HDL (time frame: 1 month). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04805502, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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