PregnancyNCT02125149
The Expecting Study
A study testing Exercise Intervention in people with Pregnancy and Obese, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to determine how a mother's health and physical activity may influence her child's growth and development. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2014to Jun 2026
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI >30
- >18 years of age
- Singleton pregnancy
- Less than 12 weeks gestation
- Sedentary
- Conceived without assisted fertility treatments
- Cleared by physician to exercise
Who cannot join
- Women with pre-existing medical conditions as determined by the PI to affect the outcomes of interest
- Women who are using recreational drugs, tobacco, or alcohol during pregnancy
- Women with contraindications to exercise during pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
Official title: Prenatal Physical Activity Intervention
The purpose of the study is to determine how a mother's health and physical activity may influence her child's growth and development.
- Being tested
- Exercise Intervention
- Keywords
- pregnancy, obese
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care |
| Intervention | Experimental | Exercise intervention from 12 week gestation until delivery Receives: Other: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of obesity in infants and children
Birth weight, body fat, and metabolism will be evaluated during the first 2 years of life.
Measured: 2 years
Secondary outcomes (2)
Maternal insulin sensitivity
Fasted blood samples will be analyzed to assess glucose and insulin.
Measured: 9 months
Maternal inflammation
Markers of inflammation will be investigated in fasted serum samples.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study start2 Sep 2014
- Primary completionJun 2026
- Study completionJun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aline Andres, Ph.D, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125149
- Sponsor's protocol ID
- 202954
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2014
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Holmes CJ, Diniz-Sousa F, Sims CR, Jansen LT, Martinez A, Dupens A 3rd, Turner D, Edwards T, Bellando J, Massey-Swindle T, Diaz EC, Borsheim E, Andres A. The Effect of an Exercise Program on Maternal Health and Birth Outcomes in Sedentary Pregnant Participants with Obesity: Randomized Controlled Trial. Med Sci Sports Exerc. 2026 Mar 1;58(3):559-571. doi: 10.1249/MSS.0000000000003888. Epub 2025 Oct 30.
PubMed 41168681Saben JL, Sims CR, Piccolo BD, Andres A. Maternal adiposity alters the human milk metabolome: associations between nonglucose monosaccharides and infant adiposity. Am J Clin Nutr. 2020 Nov 11;112(5):1228-1239. doi: 10.1093/ajcn/nqaa216.
PubMed 32844207
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Physical Activity Intervention
- ClinicalTrials.gov ID
- NCT02125149
- Acronym / sponsor ID
- 202954
- Keywords
- pregnancy, obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 2 Sep 2014 (actual)
- Primary completion
- Jun 2026 (actual)
- Study completion
- Jun 2026 (actual)
- First posted
- 29 Apr 2014 (estimated)
- 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 purpose of the study is to determine how a mother's health and physical activity may influence her child's growth and development.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care |
| Intervention | Experimental | Other: Exercise InterventionExercise intervention from 12 week gestation until delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI >30
- >18 years of age
- Singleton pregnancy
- Less than 12 weeks gestation
- Sedentary
Key exclusion criteria (3 listed)
- Women with pre-existing medical conditions as determined by the PI to affect the outcomes of interest
- Women who are using recreational drugs, tobacco, or alcohol during pregnancy
- Women with contraindications to exercise during pregnancy
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 Intervention | Other | Intervention |
Primary outcome
Risk of obesity in infants and children
Time frame: 2 years
Birth weight, body fat, and metabolism will be evaluated during the first 2 years of life.
2 secondary outcomes
Maternal insulin sensitivity
Time frame: 9 months
Maternal inflammation
Time frame: 9 months
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 24 Sep 2026.
- Derived from this study: PubMed 41168681Holmes CJ, Diniz-Sousa F, Sims CR, Jansen LT, Martinez A, Dupens A 3rd, Turner D, Edwards T, Bellando J, Massey-Swindle T, Diaz EC, Borsheim E, Andres A. The Effect of an Exercise Program on Maternal Health and Birth Outcomes in Sedentary Pregnant Participants with Obesity: Randomized Controlled Trial. Med Sci Sports Exerc. 2026 Mar 1;58(3):559-571. doi: 10.1249/MSS.0000000000003888. Epub 2025 Oct 30.
- Derived from this study: PubMed 32844207Saben JL, Sims CR, Piccolo BD, Andres A. Maternal adiposity alters the human milk metabolome: associations between nonglucose monosaccharides and infant adiposity. Am J Clin Nutr. 2020 Nov 11;112(5):1228-1239. doi: 10.1093/ajcn/nqaa216.
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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.
Aline Andres, Ph.D principal investigator
UAMS
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 Intervention in people with Pregnancy and Obese, run by Arkansas Children's Hospital Research Institute 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 7 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 24 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?
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?
Risk of obesity in infants and children (time frame: 2 years). 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 NCT02125149, which also lists 2 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 24 Sep 2026.