PregnancyNCT01790412
Gestational Diabetes: the Prevention
A study testing Exercise group in people with Pregnancy, run by Technical University of Madrid at 1 site in Spain.
Trial summary
To assess the effectiveness of an exercise program developed during pregnancy (land/aquatic activities) aerobic and muscular tonification, on control to the prevention to Gestational Diabetes. And to assess if excessive maternal weight gain is an influence in the diagnostic. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2009to Dec 2012
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women
- At week 8-14
- Adherence 80% (minimum) until the end of pregnancy
Who cannot join
- Contraindications appointed by American College of Obstetricians \& Gynecologists (ACOG)
- No adherence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gestational Diabetes. The Rol of Exercise in the Prevention
To assess the effectiveness of an exercise program developed during pregnancy (land/aquatic activities) aerobic and muscular tonification, on control to the prevention to Gestational Diabetes. And to assess if excessive maternal weight gain is an influence in the diagnostic.
Read the detailed description
A clinical, randomized controlled trial was used. 342 pregnant women without obstetric contraindications accepted informed consent for inclusion in the study. Finally, 257 were studied, 101 in intervention group (IG, n= 101) and 156 in control group (GC, n= 156). A physical exercise program three times per week during pregnancy was developed. The duration of session was 60 minutes and 50 minutes in land and water, respectively.
- Conditions
- Pregnancy
- Being tested
- Exercise group
- Keywords
- pregnancy, exercise, gestational diabetes
- Medical subject headings
- Motor Activity, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupBehavioural
Combined two land aerobic sessions and one aquatic activities session
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Three sessions per week:
Supervised exercise program Receives: Behavioral: Exercise group |
| Control | No intervention | Sedentary pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention gestational diabetes
Oral glucose tolerance test (OGTT)
Measured: weeks 24-30
Secondary outcomes (1)
Maternal weight gain
Maternal weight gain above guidelines recommendations by Institute of Medicine and National Research Council (IOM)
Measured: weeks 40-42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2009
- Primary completionDec 2012
- Study completionDec 2012
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 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
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaiza Cordero Rodríguez, Technical University of Madrid
- Investigators
- Rubén Barakat, PhD, Study director, Technical University of MadridYaiza Cordero, PhD Student, Principal investigator, Technical University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790412
- Sponsor's protocol ID
- Technical University of Madrid
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2013
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cordero Y, Mottola MF, Vargas J, Blanco M, Barakat R. Exercise Is Associated with a Reduction in Gestational Diabetes Mellitus. Med Sci Sports Exerc. 2015 Jul;47(7):1328-33. doi: 10.1249/MSS.0000000000000547.
PubMed 25333246
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestational Diabetes. The Rol of Exercise in the Prevention
- ClinicalTrials.gov ID
- NCT01790412
- Acronym / sponsor ID
- Technical University of Madrid
- Conditions
- Pregnancy
- Keywords
- pregnancy, exercise, gestational diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Technical University of MadridUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Feb 2013 (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.
To assess the effectiveness of an exercise program developed during pregnancy (land/aquatic activities) aerobic and muscular tonification, on control to the prevention to Gestational Diabetes. And to assess if excessive maternal weight gain is an influence in the diagnostic.
Detailed description
A clinical, randomized controlled trial was used. 342 pregnant women without obstetric contraindications accepted informed consent for inclusion in the study. Finally, 257 were studied, 101 in intervention group (IG, n= 101) and 156 in control group (GC, n= 156). A physical exercise program three times per week during pregnancy was developed. The duration of session was 60 minutes and 50 minutes in land and water, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Exercise groupThree sessions per week: Supervised exercise program |
| Control | No intervention | –Sedentary pregnant women |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy pregnant women
- At week 8-14
- Adherence 80% (minimum) until the end of pregnancy
Key exclusion criteria (2 listed)
- Contraindications appointed by American College of Obstetricians \& Gynecologists (ACOG)
- No adherence
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 groupCombined two land aerobic sessions and one aquatic activities session | Behavioural | Exercise group |
Primary outcome
prevention gestational diabetes
Time frame: weeks 24-30
Oral glucose tolerance test (OGTT)
1 secondary outcome
Maternal weight gain
Time frame: weeks 40-42
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 13 Feb 2013.
- Derived from this study: PubMed 25333246Cordero Y, Mottola MF, Vargas J, Blanco M, Barakat R. Exercise Is Associated with a Reduction in Gestational Diabetes Mellitus. Med Sci Sports Exerc. 2015 Jul;47(7):1328-33. doi: 10.1249/MSS.0000000000000547.
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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.
Rubén Barakat, PhD study director
Technical University of Madrid
Yaiza Cordero, PhD Student principal investigator
Technical University of Madrid
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 group in people with Pregnancy, run by Technical University of Madrid at 1 site in Spain.
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 3 inclusion and 2 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 13 Feb 2013. 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 Spain. 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?
prevention gestational diabetes (time frame: weeks 24-30). 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 NCT01790412, 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 13 Feb 2013.