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RecruitingNCT04805502Updated Jun 4, 2026

Pregnancy Exercise Mode Effect on Childhood Obesity

An interventional study of Exercise Modes in Pregnancy and Overweight and Obesity, sponsored by East Carolina University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

From the registry’s dates

  • Started Oct 2021; still recruiting 5 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Pregnancy
  • Overweight and Obesity

Browse trials for

Keywords

  • exercise modes, exercise intervention
03

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 300 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

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

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 45 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
  • between ≥ 25
  • 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
300 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 measured from venipuncture

    Time frame: 1 month

  2. 6 month Infant non-HDL

    non-HDL measured from venipuncture

    Time frame: 6 months

  3. 12 month Infant non-HDL

    non-HDL measured 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: 36 weeks gestation

  9. 1 month postpartum Maternal fasting non-HDL

    non-HDL measured from venipuncture

    Time frame: 1 month postpartum

  10. 6 months postpartum 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

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 %

    estimated body fat % from skinfolds

    Time frame: 1 month

  8. 6 month Infant Body Fat %

    estimated body fat % from skinfolds

    Time frame: 6 months

  9. 12 month Infant Body Fat %

    estimated body fat % from skinfolds

    Time frame: 12 months

  10. 1 month Infant % Muscle Mass

    estimated muscle mass % from skinfolds

    Time frame: 1 months

  11. 6 month Infant % Muscle Mass

    estimated muscle mass % from skinfolds

    Time frame: 6 months

  12. 12 month Infant % Muscle Mass

    estimated muscle mass % from skinfolds

    Time frame: 12 months

  13. 1 month Infant Resting Energy Expenditure (REE)

    estimated REE

    Time frame: 1 months

  14. 6 month Infant Resting Energy Expenditure (REE)

    estimated resting energy expenditure

    Time frame: 6 months

  15. 12 month Infant Resting Energy Expenditure (REE)

    estimated resting energy expenditure

    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 months

  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 month

  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 months 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: 16 gestation

  35. 36wk Maternal Resting Heart Rate

    resting HR

    Time frame: 36 weeks 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. 16wk Maternal Resting Blood Pressure

    resting BP

    Time frame: 16 weeks gestation

  39. 36wk Maternal Resting Blood Pressure

    resting BP

    Time frame: 36 weeks gestation

  40. 1 month postpartum Maternal Resting Blood Pressure

    resting BP

    Time frame: 1 month postpartum

  41. 6 month postpartum Maternal Resting Blood Pressure

    resting BP

    Time frame: 6 months postpartum

  42. Maternal Gestational Weight Gain (GWG)

    Gestational Weight Gain

    Time frame: at delivery

  43. 16wk Maternal Body Fat%

    Estimated body fat %

    Time frame: 16 weeks gestation

  44. 36wk Maternal Body Fat%

    Estimated body fat %

    Time frame: 36 weeks gestation

  45. 1 month Postpartum Maternal Body Fat%

    Estimated body fat %

    Time frame: 1 month postpartum

  46. 6 month Postpartum Maternal Body Fat%

    Estimated body fat %

    Time frame: 6 months postpartum

  47. 16wk Maternal Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Time frame: 16 weeks gestation

  48. 36wk Maternal Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Time frame: 36 weeks gestation

  49. 1 month postpartum Maternal Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Time frame: 1 month postpartum

  50. 6 month Postpartum Maternal Biomarkers (CRP)

    Multiplex analyses of inflammatory markers (CRP)

    Time frame: 6 months postpartum

  51. 16wk Maternal Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Time frame: 16 weeks gestation

  52. 36wk Maternal Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Time frame: 36 weeks gestation

  53. 1 month Postpartum Maternal Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Time frame: 1 month postpartum

  54. 6 month Postpartum Maternal Biomarkers (IL6)

    Multiplex analyses of inflammatory markers (IL6)

    Time frame: 6 months postpartum

  55. 16wk Maternal Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Time frame: 16 weeks gestation

  56. 36wk Maternal Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Time frame: 36 weeks gestation

  57. 1 month Postpartum Maternal Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Time frame: 1 month postpartum

  58. 6 month Postpartum Maternal Biomarkers (adiponectin)

    Multiplex analyses of inflammatory markers (adiponectin)

    Time frame: 6 months postpartum

  59. 16wk Maternal Biomarkers (cortisol)

    Multiplex analyses of inflammatory markers (cortisol)

    Time frame: 16 weeks gestation

  60. 36wk Maternal Biomarkers (cortisol)

    Multiplex analyses of inflammatory markers (cortisol)

    Time frame: 36 weeks gestation

  61. 1 month Postpartum Maternal Biomarkers (cortisol)

    Multiplex analyses of inflammatory markers (cortisol)

    Time frame: 1 month postpartum

  62. 6 month Postpartum Maternal Biomarkers (cortisol)

    Multiplex analyses of inflammatory markers (cortisol)

    Time frame: 6 months postpartum

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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 ↗

Individual participant data

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2021 (actual). Primary completion is estimated for Jan 2027, 63 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 63 months is above that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2021
First posted
Mar 18, 2021
StartActual
Oct 18, 2021
Primary completionEst.
Jan 30, 2027
CompletionEst.
Aug 30, 2027
Last update
Jun 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04805502
Lead sponsor
East Carolina University
Responsible party
Linda May (Associate Professor; Interim Dept. Chair, East Carolina University) — Principal investigator
First posted
Mar 18, 2021
Start date
Oct 18, 2021
Primary completion
Jan 30, 2027 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
Jun 4, 2026

Study contacts

Linda E May, MS, PhD
Contact
mayl@ecu.edu
2527377072
Jameta Edwards
Contact
edwardsja@ecu.edu
2527377156
Linda E May, PhD
principal investigator · PI

Oversight

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

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