Pregnancy RelatedNCT06598098
MAMA Tot - Healthy Weight Parallel Study
A study testing Exercise Modes in people with Pregnancy Related, run by East Carolina University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Exercise Modes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 40 years old
- BMI 18.5 to 24.4
- 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
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- 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.
United States1 site, 1 recruiting
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Linda E May, MS, PhD, 252-737-7072, mayl@ecu.edu
James DeVente, MD, deventeja@ecu.edu
About this 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. 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.
Read more
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.
- Conditions
- Pregnancy Related
- Being tested
- Exercise Modes
- Keywords
- exercise modes, exercise intervention
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 group | Role | What they receive |
|---|---|---|
| Aerobic Exercise (AE) | Experimental | 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. Receives: Behavioral: Exercise Modes |
| Resistance Exercise (RE) | Experimental | 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). Receives: Behavioral: Exercise Modes |
| Combination Exercise (AERE) | Experimental | 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. Receives: Behavioral: Exercise Modes |
| Control (no exercise) | No intervention | The 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 month Infant non-HDL
non-HDL measures from venipuncture
Measured: 1 month
6 month Infant non-HDL
non-HDL measures from venipuncture
Measured: 6 months
12 month Infant non-HDL
non-HDL measures from venipuncture
Measured: 12 months
1 month infant BMI z-score
BMI normalized
Measured: 1 month
6 month infant BMI z-score
BMI normalized
Measured: 6 months
12 month infant BMI z-score
BMI normalized
Measured: 12 months
Enrollment (8-13wks) Maternal fasting non-HDL
non-HDL measured from venipuncture
Measured: enrollment (~8-13 wks gestation)
36wk Maternal fasting non-HDL
non-HDL measured from venipuncture
Measured: 36wks gestation
1 month Maternal fasting non-HDL
non-HDL measured from venipuncture
Measured: 1 month postpartum
6 month Maternal fasting non-HDL
non-HDL measured from venipuncture
Measured: 6 months postpartum
Adverse Pregnancy Outcomes
Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes [GDM], preeclampsia, hypertension)
Measured: At delivery
12 month Maternal fasting non-HDL
non-HDL measured from venipuncture
Measured: 12 months postpartum
Secondary outcomes (69)
1 month infant Resting Heart Rate
resting HR
Measured: 1 month
6 month infant Resting Heart Rate
resting HR
Measured: 6 months
12 month infant Resting Heart Rate
resting HR
Measured: 12 months
1 month infant Resting Blood Pressure
resting BP
Measured: 1 month
6 month infant Resting Blood Pressure
resting BP
Measured: 6 months
12 month infant Resting Blood Pressure
resting BP
Measured: 12 months
1 month infant Body Fat %
body fat % from skinfolds
Measured: 1 month
6 month infant Body Fat %
body fat % from skinfolds
Measured: 6 months
12 month infant Body Fat %
body fat % from skinfolds
Measured: 12 months
1 month infant % Muscle Mass
muscle mass % from skinfolds
Measured: 1 month
6 month infant % Muscle Mass
muscle mass % from skinfolds
Measured: 6 months
12 month infant % Muscle Mass
muscle mass % from skinfolds
Measured: 12 months
1 month Infant Resting Energy Expenditure (REE)
resting REE
Measured: 1 month
6 month Infant Resting Energy Expenditure (REE)
resting REE
Measured: 6 months
12 month Infant Resting Energy Expenditure (REE)
resting REE
Measured: 12 months
1 month Infant Neuromotor Assessment
Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
Measured: 1 month
6 month Infant Neuromotor Assessment
Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
Measured: 6 months
12 month Infant Neuromotor Assessment
Peabody Developmental Motor Scale (1st - 99th percentile) - the higher the percentile the better
Measured: 12 months
1 month Infant Veggie Meter
Raman Spectroscopy-Skin Carotenoid assessments
Measured: 1 month
6 month Infant Veggie Meter
Raman Spectroscopy-Skin Carotenoid assessments
Measured: 6 months
12 month Infant Veggie Meter
Raman Spectroscopy-Skin Carotenoid assessments
Measured: 12 months
1 month Infant Blood Biomarkers (CRP)
Multiplex analyses of inflammatory markers (CRP)
Measured: 1 month
6 month Infant Blood Biomarkers (CRP)
Multiplex analyses of inflammatory markers (CRP)
Measured: 6 months
12 month Infant Blood Biomarkers (CRP)
Multiplex analyses of inflammatory markers (CRP)
Measured: 12 months
1 month Infant Blood Biomarkers (IL6)
Multiplex analyses of inflammatory markers (IL6)
Measured: 1 month
6 month Infant Blood Biomarkers (IL6)
Multiplex analyses of inflammatory markers (IL6)
Measured: 6 months
12 month Infant Blood Biomarkers (IL6)
Multiplex analyses of inflammatory markers (IL6)
Measured: 12 months
1 month Infant Blood Biomarkers (adiponectin)
Multiplex analyses of inflammatory markers (adiponectin)
Measured: 1 month
6 month Infant Blood Biomarkers (adiponectin)
Multiplex analyses of inflammatory markers (adiponectin)
Measured: 6 months
12 month Infant Blood Biomarkers (adiponectin)
Multiplex analyses of inflammatory markers (adiponectin)
Measured: 12 months
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
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
12 month Infant Metabolomics
Metabolomic pathway analysis of significantly different blood metabolites based on p-value less than or equal to 0.05
Measured: 12 months
16wk Maternal Resting Heart Rate
resting HR
Measured: 16wks gestation
36wk Maternal Resting Heart Rate
resting HR
Measured: 36wks gestation
1 month Postpartum Maternal Resting Heart Rate
resting HR
Measured: 1 month postpartum
6 month Postpartum Maternal Resting Heart Rate
resting HR
Measured: 6 months postpartum
12 month Postpartum Maternal Resting Heart Rate
resting HR
Measured: 12 months postpartum
16wk Maternal Resting Blood Pressure
resting BP
Measured: 16wks gestation
36wk Maternal Resting Blood Pressure
resting BP
Measured: 36wks gestation
1 month Postpartum Maternal Resting Blood Pressure
resting BP
Measured: 1 month postpartum
6 month Postpartum Maternal Resting Blood Pressure
resting BP
Measured: 6 months postpartum
12 month Postpartum Maternal Resting Blood Pressure
resting BP
Measured: 12 months postpartum
Maternal Gestational Weight Gain (GWG)
Gestational Weight Gain
Measured: At delivery
16wk Maternal Body Fat %
estimated body fat %
Measured: 16wks gestation
36wk Maternal Body Fat %
estimated body fat %
Measured: 36wks gestation
1 month Postpartum Maternal Body Fat %
estimated body fat %
Measured: 1 month postpartum
6 month Postpartum Maternal Body Fat %
estimated body fat %
Measured: 6 months postpartum
12 month Postpartum Maternal Body Fat %
estimated body fat %
Measured: 12 months postpartum
16wk Maternal Biomarkers (CRP)
Multiplex analyses of inflammatory markers (CRP)
Measured: 16wks gestation
36wk Maternal Biomarkers (CRP)
Multiplex analyses of inflammatory markers (CRP)
Measured: 36wks gestation
1 month Postpartum Maternal Biomarkers (CRP)
Multiplex analyses of inflammatory markers (CRP)
Measured: 1 month postpartum
6 month Postpartum Maternal Biomarkers (CRP)
Multiplex analyses of inflammatory markers (CRP)
Measured: 6 months postpartum
12 month Postpartum Maternal Biomarkers (CRP)
Multiplex analyses of inflammatory markers (CRP)
Measured: 12 months postpartum
16wk Maternal Biomarkers (IL6)
Multiplex analyses of inflammatory markers (IL6)
Measured: 16wks gestation
36wk Maternal Biomarkers (IL6)
Multiplex analyses of inflammatory markers (IL6)
Measured: 36wks gestation
1 month Postpartum Maternal Biomarkers (IL6)
Multiplex analyses of inflammatory markers (IL6)
Measured: 1 month postpartum
6 month Postpartum Maternal Biomarkers (IL6)
Multiplex analyses of inflammatory markers (IL6)
Measured: 6 months postpartum
12 month Postpartum Maternal Biomarkers (IL6)
Multiplex analyses of inflammatory markers (IL6)
Measured: 12 months postpartum
16wks Maternal Biomarkers (adiponectin)
Multiplex analyses of inflammatory markers (adiponectin)
Measured: 16wks gestation
36wks Maternal Biomarkers (adiponectin)
Multiplex analyses of inflammatory markers (adiponectin)
Measured: 36wks gestation
1 month postpartum Maternal Biomarkers (adiponectin)
Multiplex analyses of inflammatory markers (adiponectin)
Measured: 1 month postpartum
6 month postpartum Maternal Biomarkers (adiponectin)
Multiplex analyses of inflammatory markers (adiponectin)
Measured: 6 months postpartum
12 month postpartum Maternal Biomarkers (adiponectin)
Multiplex analyses of inflammatory markers (adiponectin)
Measured: 12 months postpartum
16wks Maternal Biomarkers (cortisol)
Multiplex analyses of inflammatory markers (cortisol)
Measured: 16wks gestation
36wks Maternal Biomarkers (cortisol)
Multiplex analyses of inflammatory markers (cortisol)
Measured: 36wks gestation
1 month Postpartum Maternal Biomarkers (cortisol)
Multiplex analyses of inflammatory markers (cortisol)
Measured: 1 month postpartum
6 month Postpartum Maternal Biomarkers (cortisol)
Multiplex analyses of inflammatory markers (cortisol)
Measured: 6 months postpartum
12 month Postpartum Maternal Biomarkers (cortisol)
Multiplex analyses of inflammatory markers (cortisol)
Measured: 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Oct 2021
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda May, East Carolina University
- Investigators
- Linda May, MS, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598098
- Sponsor's protocol ID
- 20-002367
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2024
- Last updated
- 11 Sep 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAMA Tot - Healthy Weight Parallel Study
- ClinicalTrials.gov ID
- NCT06598098
- Acronym / sponsor ID
- 20-002367
- Conditions
- Pregnancy Related
- Keywords
- exercise modes, exercise intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise (AE) | Experimental | Behavioral: Exercise ModesAll 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. |
| Resistance Exercise (RE) | Experimental | Behavioral: Exercise ModesAll 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). |
| Combination Exercise (AERE) | Experimental | Behavioral: Exercise ModesAll 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. |
| Control (no exercise) | No intervention | –The Control group will participate in weekly sessions that focus on stretching, breathing, and healthy lifestyle. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18 to 40 years old
- BMI 18.5 to 24.4
- Pregnancy: Singleton; ≤ 16 weeks gestation
- Clearance by Obstetric provider for exercise
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ModesModerate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise | Behavioural | Aerobic Exercise (AE), Combination Exercise (AERE), Resistance Exercise (RE) |
Primary outcome
1 month Infant non-HDL
Time frame: 1 month
non-HDL measures from venipuncture
6 month Infant non-HDL
Time frame: 6 months
non-HDL measures from venipuncture
12 month Infant non-HDL
Time frame: 12 months
non-HDL measures from venipuncture
1 month infant BMI z-score
Time frame: 1 month
BMI normalized
6 month infant BMI z-score
Time frame: 6 months
BMI normalized
12 month infant BMI z-score
Time frame: 12 months
BMI normalized
Enrollment (8-13wks) Maternal fasting non-HDL
Time frame: enrollment (~8-13 wks gestation)
non-HDL measured from venipuncture
36wk Maternal fasting non-HDL
Time frame: 36wks gestation
non-HDL measured from venipuncture
1 month Maternal fasting non-HDL
Time frame: 1 month postpartum
non-HDL measured from venipuncture
6 month Maternal fasting non-HDL
Time frame: 6 months postpartum
non-HDL measured from venipuncture
Adverse Pregnancy Outcomes
Time frame: At delivery
Presence or absence of Adverse Pregnancy outcomes (preterm birth, gestational diabetes [GDM], preeclampsia, hypertension)
12 month Maternal fasting non-HDL
Time frame: 12 months postpartum
non-HDL measured from venipuncture
69 secondary outcomes
1 month infant Resting Heart Rate
Time frame: 1 month
6 month infant Resting Heart Rate
Time frame: 6 months
12 month infant Resting Heart Rate
Time frame: 12 months
1 month infant Resting Blood Pressure
Time frame: 1 month
6 month infant Resting Blood Pressure
Time frame: 6 months
12 month infant Resting Blood Pressure
Time frame: 12 months
1 month infant Body Fat %
Time frame: 1 month
6 month infant Body Fat %
Time frame: 6 months
12 month infant Body Fat %
Time frame: 12 months
1 month infant % Muscle Mass
Time frame: 1 month
6 month infant % Muscle Mass
Time frame: 6 months
12 month infant % Muscle Mass
Time frame: 12 months
1 month Infant Resting Energy Expenditure (REE)
Time frame: 1 month
6 month Infant Resting Energy Expenditure (REE)
Time frame: 6 months
12 month Infant Resting Energy Expenditure (REE)
Time frame: 12 months
1 month Infant Neuromotor Assessment
Time frame: 1 month
6 month Infant Neuromotor Assessment
Time frame: 6 months
12 month Infant Neuromotor Assessment
Time frame: 12 months
1 month Infant Veggie Meter
Time frame: 1 month
6 month Infant Veggie Meter
Time frame: 6 months
12 month Infant Veggie Meter
Time frame: 12 months
1 month Infant Blood Biomarkers (CRP)
Time frame: 1 month
6 month Infant Blood Biomarkers (CRP)
Time frame: 6 months
12 month Infant Blood Biomarkers (CRP)
Time frame: 12 months
1 month Infant Blood Biomarkers (IL6)
Time frame: 1 month
6 month Infant Blood Biomarkers (IL6)
Time frame: 6 months
12 month Infant Blood Biomarkers (IL6)
Time frame: 12 months
1 month Infant Blood Biomarkers (adiponectin)
Time frame: 1 month
6 month Infant Blood Biomarkers (adiponectin)
Time frame: 6 months
12 month Infant Blood Biomarkers (adiponectin)
Time frame: 12 months
1 month Infant Metabolomics
Time frame: 1 month
6 month Infant Metabolomics
Time frame: 6 months
12 month Infant Metabolomics
Time frame: 12 months
16wk Maternal Resting Heart Rate
Time frame: 16wks gestation
36wk Maternal Resting Heart Rate
Time frame: 36wks gestation
1 month Postpartum Maternal Resting Heart Rate
Time frame: 1 month postpartum
6 month Postpartum Maternal Resting Heart Rate
Time frame: 6 months postpartum
12 month Postpartum Maternal Resting Heart Rate
Time frame: 12 months postpartum
16wk Maternal Resting Blood Pressure
Time frame: 16wks gestation
36wk Maternal Resting Blood Pressure
Time frame: 36wks gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Derived from this study: PubMed 42636143Claiborne 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.
- Individual participant dataSharing planned: Undecided. de-identified data can be shared upon request to researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda May, MS, PhD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Modes in people with Pregnancy Related, 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 11 Sep 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 (252-737-7072, 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 12 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 NCT06598098, which also lists 1 linked publication.
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 11 Sep 2026.