ExerciseNCT03838146
Influence of Maternal Exercise on Infant Skeletal Muscle and Metabolomics
A study testing Types of Exercise in people with Exercise, run by East Carolina University at 1 site in United States.
Trial summary
The American Heart Association suggests that heart disease prevention should target pregnancy and the first year of life; however, there is a fundamental gap in knowledge regarding the effects of prenatal exercise on the prevention of heart disease.[1, 2] Insulin resistance in skeletal muscle is believed to be a… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Types of Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- <16 weeks gestation
- singleton pregnancy telephone/email contact
Who cannot join
- chronic conditions i.e. diabetes, hypertension, HIV, etc.
- use of medications that affect fetal development;
- use of alcohol, tobacco, or other drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27834
About this study
The American Heart Association suggests that heart disease prevention should target pregnancy and the first year of life; however, there is a fundamental gap in knowledge regarding the effects of prenatal exercise on the prevention of heart disease.[1, 2] Insulin resistance in skeletal muscle is believed to be a critical contributor to the metabolic syndrome which increases the risk for cardiovascular disease (CVD). Conversely, exercise improves insulin sensitivity and many other facets of skeletal muscle function and metabolism; however, it is unclear if this positive effect can be "imprinted" in the skeletal muscle of the fetus with maternal exercise and accordingly diminish CVD risk in offspring. Our previous studies found that exercise during pregnancy leads to improved heart measures and reduced adiposity.[3-6] These studies demonstrated the potential for maternal exercise to reduce risk for CVD, but the cellular mechanisms involved, however, are not clearly evident. The proposed project will fill this critical gap and assess the influence of maternal exercise intervention to "imprint" progenitor stem cells in the fetus (umbilical cord tissue) to develop into insulin sensitive skeletal muscle and also improve indices of infant morphometry and movement. Using a randomized design, 160 women will perform either exercise intervention (aerobic training, resistance training, or both) or usual care (controls). Infant cord tissue and blood will be sampled at birth while blood will be sampled at 1 month of age. Similarly, infant neuromotor and morphometric examinations will be performed at 1 month. and at 1-month of age via blood sample, neuromotor, and morphometric examinations. The rationale for the project is to elucidate the effects of maternal exercise on offspring health outcomes and determine specific metabolic targets predictive of offspring long-term disease risk. The investigators will test the central hypothesis that exercise during pregnancy alters skeletal muscle in a manner which decreases the risk of heart disease in offspring. To test this central hypothesis, the investigators will pursue two specific aims: Aim 1- Determine the ability of regular maternal exercise to imprint key myocellular metabolic (insulin sensitivity) properties of offspring mesenchymal stem cells (MSC), neuromotor function, and morphometry. Aim 2- Determine the distinct abilities of regular maternal exercise to imprint the metabolome of offspring MSC.
Read the detailed description
Is offspring skeletal muscle function and metabolism imprinted by regular maternal exercise? What offspring metabolome markers are altered with regular maternal exercise? The investigators will use a randomized design of 160 women to either exercise intervention (aerobic training, resistance training, or both) or usual care (controls). Infant cord tissue and blood will be sampled at birth while blood will be sampled at 1 month of age. Similarly, infant neuromotor and morphometric examinations will be performed at 1 month. and at 1-month of age via blood sample, neuromotor, and morphometric examinations. The rationale for the project is to elucidate the effects of maternal exercise on offspring health outcomes and determine specific metabolic targets predictive of offspring long-term disease risk.
- Conditions
- Exercise
- Being tested
- Types of Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Types of ExerciseBehavioural
moderate intensity exercise
| Study group | Role | What they receive |
|---|---|---|
| Non-Exercise Control | No intervention | This group will come in regularly for measurements, but will not have an exercise intervention. If necessary for retention of participants, then we will meet with controls 3 times a week to stress reduction techniques. |
| Resistance Type of Exercise | Experimental | This group will participate in resistance exercise intervention 3 times per week from enrollment to delivery.The resistance training (RT) group will perform three sets of 12-15 repetitions of 10-12 resistance exercises in a circuit, with rest of 30-60 seconds between sets as needed. Participants will use a combination of Cybex machines (Cybex International, Medway, MA), resistance bands, and free weights. Routines will change every 3 weeks to add variety and improve compliance. Receives: Behavioral: Types of Exercise |
| Combination Type of Exercise | Experimental | This group will participate in combination (aerobic+resistance) exercise intervention 3 times per week from enrollment to delivery. The combination (CT) group will alternate between resistance and aerobic exercises. Participants will perform 4.5 minute bouts of aerobic exercise and perform four resistance exercises of 12-15 repetition that vary between aerobic bouts[17-19]. The aerobic exercise bouts will be performed on the aerobic machine of the participant's choosing as described above. The resistance routine will follow similar guidelines as the resistance group. Receives: Behavioral: Types of Exercise |
| Aerobic Type of Exercise | Experimental | This group will participate in aerobic exercise intervention 3 times per week from enrollment to delivery. The aerobic training (AT) group will perform a continuous aerobic exercise of their choosing (e.g., treadmill, ellipticals, stairs, Zumba, or outside walking/jogging). Participants' ability to choose an aerobic activity that they are comfortable with and enjoy is intended to improve compliance. Receives: Behavioral: Types of Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Skeletal Muscles cells grown from MSCs will have insulin responsiveness measured
Western blot analysis of Akt phosphorylation will be conducted on cell lysates from myotubes under basal or following insulin-stimulation. Glycogen synthesis will be measured under basal and insulin-stimulated conditions. Data will be presented as % change in glycogen synthesis following insulin stimulation.
Measured: At Birth
Secondary outcomes (4)
Global and targeted metabolomics analysis will be conducted to map out pathways and mechanisms from regular maternal exercise. Docosahexaenoic acid (DHA), Eicosapentaenoic Acid (EPA), Docosapentaenoic Acid (DPA), and Arachidonic acid (ARA).
Targeted quantitative LC/MS analysis of DHA and EPA from participants at 16 (pre-training intervention) and 36 weeks, DHA and EPA levels from umbilical cord tissue sample, and DHA and EPA levels from umbilical cord (infant) blood will be compared between groups.
From our pathway analysis of identified metabolites of interest, we will be able to map the metabolites of interest within common pathways related to maternal exercise exposure.
Measured: At 16 weeks and 36 weeks gestation
Peabody Developmental Motor Scales, 2nd edition (PDMS-2) will be performed by a pediatric physical therapist (blinded to group classification) to measure gross motor skills of infants up to 12 months of age.
3 of the 6 subtests can be used on 1 month olds. All items scored from 0-2, which include:
- Reflexes: 8-item subtest that measures child's ability to react to environmental events.
- Stationary: 30-item subtest that measures child's ability to control body within center of gravity and retain equilibrium
- Locomotion: 89-item subtest that measures child's ability to move from one place to another through crawling, walking, running, hopping, and jumping forward we only do the Reflexes Range (0-16), Stationary Range (0-60), and Locomotion Range (0-178) subtests. Each subtest score is also converted to percentile (comparing infant's behavior to the normative sample). All subtest score are summed to determine the Gross Motor Quotient (GMQ), and a GMQ percentile score will be determined.
Measured: at 1 month postnatal visit
A trained (blinded) researcher will measure bicep, tricep, and subscapular skinfold measures, circumferences (abdominal, head, mid-upper arm), and lengths (body, femur, leg, humeral). All measures are recorded as mm.
All measures will be taken in duplicate on the right side following published standards for skinfold and circumference location.
Data will be used to compare individual skinfolds, sum of skinfolds and circumferences measures between groups
Measured: at 1 month postnatal visit
A trained (blinded) researcher will measure body weight on an infant scale
Body weight will be done to the nearest tenth of a kilogram. Data will be used to compare body weight measures between groups
Measured: at 1 month postnatal visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Sep 2018
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies 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
- comparing 3 exercise interventions to a control (non-exercise) group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Linda May, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838146
- Sponsor's protocol ID
- 12-002524b
- Status last verified
- Aug 2023
- First submitted
- 5 Nov 2018
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we will not be sharing individual data with other researchers
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 41187954Sanchez-Parente S, Kern K, Claiborne A, Wisseman B, Steen D, Roenker B, Lilley A, Strom C, Newton E, DeVente J, Mouro S, Collier D, Kuehn D, Dubose KD, Kelley G, McMillan AG, Castro-Pinero J, Aparicio VA, May LE. Impact of Supervised-concurrent Exercise During Pregnancy on Infant Neuromotor Skills: A Post-hoc Analysis Stratified by Maternal BMI. Sports Med Open. 2025 Jun 20;11(1):78. doi: 10.1186/s40798-025-00886-x.
PubMed 40542229Jevtovic 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 39716848Jevtovic F, Claiborne A, Biagioni EM, Collier DN, DeVente JE, Mouro S, Kaneko-Tarui T, O-Tierney-Ginn PF, Goodyear LJ, Houmard JA, Broskey NT, May LE. Paternal obesity decreases infant MSC mitochondrial functional capacity. Am J Physiol Endocrinol Metab. 2024 Oct 1;327(4):E441-E448. doi: 10.1152/ajpendo.00239.2024. Epub 2024 Aug 14.
PubMed 39140975Jevtovic 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 38858465Jevtovic F, Zheng D, Houmard JA, Kern K, Claiborne A, Lopez CA, Broskey NT, Isler C, DeVente J, Newton E, May LE. Myogenically differentiated mesenchymal stem cell insulin sensitivity is associated with infant adiposity at 1 and 6 months of age. Obesity (Silver Spring). 2023 Sep;31(9):2349-2358. doi: 10.1002/oby.23829. Epub 2023 Aug 8.
PubMed 37551412Jevtovic F, Zheng D, Houmard JA, Krassovskaia PM, Lopez CA, Wisseman BL, Steen DM, Broskey NT, Isler C, DeVente J, Fang X, May LE. Effects of Maternal Exercise Modes on Glucose and Lipid Metabolism in Offspring Stem Cells. J Clin Endocrinol Metab. 2023 Jun 16;108(7):e360-e370. doi: 10.1210/clinem/dgad059.
PubMed 36722208McDonald SM, Mouro S, Wisseman B, Isler C, DeVente J, Newton E, Hildebrand J, Kuehn D, Kelley G, Chasan-Taber L, Broskey NT, May LE. Influence of prenatal exercise on the relationship between maternal overweight and obesity and select delivery outcomes. Sci Rep. 2022 Oct 15;12(1):17343. doi: 10.1038/s41598-022-22283-0.
PubMed 36243785
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Maternal Exercise on Infant Skeletal Muscle and Metabolomics
- ClinicalTrials.gov ID
- NCT03838146
- Acronym / sponsor ID
- 12-002524b
- Conditions
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 12 Feb 2019 (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 American Heart Association suggests that heart disease prevention should target pregnancy and the first year of life; however, there is a fundamental gap in knowledge regarding the effects of prenatal exercise on the prevention of heart disease.[1, 2] Insulin resistance in skeletal muscle is believed to be a critical contributor to the metabolic syndrome which increases the risk for cardiovascular disease (CVD). Conversely, exercise improves insulin sensitivity and many other facets of skeletal muscle function and metabolism; however, it is unclear if this positive effect can be "imprinted" in the skeletal muscle of the fetus with maternal exercise and accordingly diminish CVD risk in offspring. Our previous studies found that exercise during pregnancy leads to improved heart measures and reduced adiposity.[3-6] These studies demonstrated the potential for maternal exercise to reduce risk for CVD, but the cellular mechanisms involved, however, are not clearly evident. The proposed project will fill this critical gap and assess the influence of maternal exercise intervention to "imprint" progenitor stem cells in the fetus (umbilical cord tissue) to develop into insulin sensitive skeletal muscle and also improve indices of infant morphometry and movement. Using a randomized design, 160 women will perform either exercise intervention (aerobic training, resistance training, or both) or usual care (controls). Infant cord tissue and blood will be sampled at birth while blood will be sampled at 1 month of age. Similarly, infant neuromotor and morphometric examinations will be performed at 1 month. and at 1-month of age via blood sample, neuromotor, and morphometric examinations. The rationale for the project is to elucidate the effects of maternal exercise on offspring health outcomes and determine specific metabolic targets predictive of offspring long-term disease risk. The investigators will test the central hypothesis that exercise during pregnancy alters skeletal muscle in a manner which decreases the risk of heart disease in offspring. To test this central hypothesis, the investigators will pursue two specific aims: Aim 1- Determine the ability of regular maternal exercise to imprint key myocellular metabolic (insulin sensitivity) properties of offspring mesenchymal stem cells (MSC), neuromotor function, and morphometry. Aim 2- Determine the distinct abilities of regular maternal exercise to imprint the metabolome of offspring MSC.
Detailed description
Is offspring skeletal muscle function and metabolism imprinted by regular maternal exercise? What offspring metabolome markers are altered with regular maternal exercise? The investigators will use a randomized design of 160 women to either exercise intervention (aerobic training, resistance training, or both) or usual care (controls). Infant cord tissue and blood will be sampled at birth while blood will be sampled at 1 month of age. Similarly, infant neuromotor and morphometric examinations will be performed at 1 month. and at 1-month of age via blood sample, neuromotor, and morphometric examinations. The rationale for the project is to elucidate the effects of maternal exercise on offspring health outcomes and determine specific metabolic targets predictive of offspring long-term disease risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
- Model description
- comparing 3 exercise interventions to a control (non-exercise) group
| Arm | Type | Receives |
|---|---|---|
| Non-Exercise Control | No intervention | –This group will come in regularly for measurements, but will not have an exercise intervention. If necessary for retention of participants, then we will meet with controls 3 times a week to stress reduction techniques. |
| Resistance Type of Exercise | Experimental | Behavioral: Types of ExerciseThis group will participate in resistance exercise intervention 3 times per week from enrollment to delivery.The resistance training (RT) group will perform three sets of 12-15 repetitions of 10-12 resistance exercises in a circuit, with rest of 30-60 seconds between sets as needed. Participants will use a combination of Cybex machines (Cybex International, Medway, MA), resistance bands, and free weights. Routines will change every 3 weeks to add variety and improve compliance. |
| Combination Type of Exercise | Experimental | Behavioral: Types of ExerciseThis group will participate in combination (aerobic+resistance) exercise intervention 3 times per week from enrollment to delivery. The combination (CT) group will alternate between resistance and aerobic exercises. Participants will perform 4.5 minute bouts of aerobic exercise and perform four resistance exercises of 12-15 repetition that vary between aerobic bouts[17-19]. The aerobic exercise bouts will be performed on the aerobic machine of the participant's choosing as described above. The resistance routine will follow similar guidelines as the resistance group. |
| Aerobic Type of Exercise | Experimental | Behavioral: Types of ExerciseThis group will participate in aerobic exercise intervention 3 times per week from enrollment to delivery. The aerobic training (AT) group will perform a continuous aerobic exercise of their choosing (e.g., treadmill, ellipticals, stairs, Zumba, or outside walking/jogging). Participants' ability to choose an aerobic activity that they are comfortable with and enjoy is intended to improve compliance. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- <16 weeks gestation
- singleton pregnancy telephone/email contact
Key exclusion criteria (3 listed)
- chronic conditions i.e. diabetes, hypertension, HIV, etc.
- use of medications that affect fetal development;
- use of alcohol, tobacco, or other drugs
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 |
|---|---|---|
| Types of Exercisemoderate intensity exercise | Behavioural | Aerobic Type of Exercise, Combination Type of Exercise, Resistance Type of Exercise |
Primary outcome
Human Skeletal Muscles cells grown from MSCs will have insulin responsiveness measured
Time frame: At Birth
Western blot analysis of Akt phosphorylation will be conducted on cell lysates from myotubes under basal or following insulin-stimulation. Glycogen synthesis will be measured under basal and insulin-stimulated conditions. Data will be presented as % change in glycogen synthesis following insulin stimulation.
4 secondary outcomes
Global and targeted metabolomics analysis will be conducted to map out pathways and mechanisms from regular maternal exercise. Docosahexaenoic acid (DHA), Eicosapentaenoic Acid (EPA), Docosapentaenoic Acid (DPA), and Arachidonic acid (ARA).
Time frame: At 16 weeks and 36 weeks gestation
Peabody Developmental Motor Scales, 2nd edition (PDMS-2) will be performed by a pediatric physical therapist (blinded to group classification) to measure gross motor skills of infants up to 12 months of age.
Time frame: at 1 month postnatal visit
A trained (blinded) researcher will measure bicep, tricep, and subscapular skinfold measures, circumferences (abdominal, head, mid-upper arm), and lengths (body, femur, leg, humeral). All measures are recorded as mm.
Time frame: at 1 month postnatal visit
A trained (blinded) researcher will measure body weight on an infant scale
Time frame: at 1 month postnatal visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Derived from this study: PubMed 41187954Jevtovic 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.
- Derived from this study: PubMed 40542229Sanchez-Parente S, Kern K, Claiborne A, Wisseman B, Steen D, Roenker B, Lilley A, Strom C, Newton E, DeVente J, Mouro S, Collier D, Kuehn D, Dubose KD, Kelley G, McMillan AG, Castro-Pinero J, Aparicio VA, May LE. Impact of Supervised-concurrent Exercise During Pregnancy on Infant Neuromotor Skills: A Post-hoc Analysis Stratified by Maternal BMI. Sports Med Open. 2025 Jun 20;11(1):78. doi: 10.1186/s40798-025-00886-x.
- Derived from this study: PubMed 39716848Jevtovic 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.
- Derived from this study: PubMed 39140975Jevtovic F, Claiborne A, Biagioni EM, Collier DN, DeVente JE, Mouro S, Kaneko-Tarui T, O-Tierney-Ginn PF, Goodyear LJ, Houmard JA, Broskey NT, May LE. Paternal obesity decreases infant MSC mitochondrial functional capacity. Am J Physiol Endocrinol Metab. 2024 Oct 1;327(4):E441-E448. doi: 10.1152/ajpendo.00239.2024. Epub 2024 Aug 14.
- Derived from this study: PubMed 38858465Jevtovic 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.
- Derived from this study: PubMed 37551412Jevtovic F, Zheng D, Houmard JA, Kern K, Claiborne A, Lopez CA, Broskey NT, Isler C, DeVente J, Newton E, May LE. Myogenically differentiated mesenchymal stem cell insulin sensitivity is associated with infant adiposity at 1 and 6 months of age. Obesity (Silver Spring). 2023 Sep;31(9):2349-2358. doi: 10.1002/oby.23829. Epub 2023 Aug 8.
- Derived from this study: PubMed 36722208Jevtovic F, Zheng D, Houmard JA, Krassovskaia PM, Lopez CA, Wisseman BL, Steen DM, Broskey NT, Isler C, DeVente J, Fang X, May LE. Effects of Maternal Exercise Modes on Glucose and Lipid Metabolism in Offspring Stem Cells. J Clin Endocrinol Metab. 2023 Jun 16;108(7):e360-e370. doi: 10.1210/clinem/dgad059.
- Derived from this study: PubMed 36243785McDonald SM, Mouro S, Wisseman B, Isler C, DeVente J, Newton E, Hildebrand J, Kuehn D, Kelley G, Chasan-Taber L, Broskey NT, May LE. Influence of prenatal exercise on the relationship between maternal overweight and obesity and select delivery outcomes. Sci Rep. 2022 Oct 15;12(1):17343. doi: 10.1038/s41598-022-22283-0.
- Individual participant dataSharing planned: No. we will not be sharing individual data with other 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Types of Exercise in people with Exercise, 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 8 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Skeletal Muscles cells grown from MSCs will have insulin responsiveness measured (time frame: At Birth). 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 NCT03838146, which also lists 8 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 8 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.