PregnancyNCT01790347
Physical Exercise Controls Gestational Weight Gain
A study testing Exercise group in people with Pregnancy, run by Technical University of Madrid at 1 site in Spain.
Trial summary
An estimated two-thirds to three- quarters of women experience gestational weight gain outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30% inadequate gain. Not gaining the adequate weight gain is strongly associated with several maternal and fetal complications.. 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
- 2,350 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2007to Jun 2011
- 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
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Being able to communicate in spanish
Who cannot join
- Obstetrician complications
- Being interested in the study after 18 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of a Supervised Physical Exercise Program as a Alternative on the Control of Maternal Gestational Weight Gain
An estimated two-thirds to three- quarters of women experience gestational weight gain outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30% inadequate gain. Not gaining the adequate weight gain is strongly associated with several maternal and fetal complications..
Read the detailed description
The aim of this study was to assess the role of a supervised exercise programme on the control of maternal gestational weight gain and its consequences.
- Conditions
- Pregnancy
- Being tested
- Exercise group
- Keywords
- Exercise, Aerobic, Resistance training, Pregnancy, Maternal weight gain, IOM recommendations
- Medical subject headings
- Motor Activity, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupBehavioural
The physical conditioning program included a total of three 50-55 minute sessions per week. Pregnant women started at 9 weeks and finished at 38-39 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate.
Each session included 10 min of warm up and 10 min of cool down which included an specific pelvic floor muscles training. The core section of the exercise session lasted from 25 to 30 min and included moderate-intensity aerobic exercises once a week and resistance exercises twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Not described Receives: Behavioral: Exercise group |
| Control group | No intervention | Sedentary pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal gestational weight gain
Maternal weight gain
Measured: 40-42 weeks
Secondary outcomes (2)
Maternal gestational diabetes
Gestational diabetes
Measured: From 24 to 26 week
Fetal body mass index
Baby body Mass index (BMI)
Measured: 38-42 weeks
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 startSep 2007
- Primary completionJan 2011
- Study completionJun 2011
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
- 2,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Perales Santaella, Technical University of Madrid
- Investigators
- Ruben Barakat, PhD, Study director, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790347
- Sponsor's protocol ID
- Gestational weight gain
- Status last verified
- Jan 2013
- First submitted
- 4 Feb 2013
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ruiz JR, Perales M, Pelaez M, Lopez C, Lucia A, Barakat R. Supervised exercise-based intervention to prevent excessive gestational weight gain: a randomized controlled trial. Mayo Clin Proc. 2013 Dec;88(12):1388-97. doi: 10.1016/j.mayocp.2013.07.020.
PubMed 24290112
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Supervised Physical Exercise Program as a Alternative on the Control of Maternal Gestational Weight Gain
- ClinicalTrials.gov ID
- NCT01790347
- Acronym / sponsor ID
- Gestational weight gain
- Conditions
- Pregnancy
- Keywords
- Exercise, Aerobic, Resistance training, Pregnancy, Maternal weight gain, IOM recommendations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,350 participants (actual)
- Lead sponsor
- Technical University of MadridUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2011 (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.
An estimated two-thirds to three- quarters of women experience gestational weight gain outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30% inadequate gain. Not gaining the adequate weight gain is strongly associated with several maternal and fetal complications..
Detailed description
The aim of this study was to assess the role of a supervised exercise programme on the control of maternal gestational weight gain and its consequences.
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 group |
| Control group | 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 (2 listed)
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Being able to communicate in spanish
Key exclusion criteria (4 listed)
- Obstetrician complications
- Being interested in the study after 18 weeks
- Not being regular in physical exercise program
- Younger than 18 years old
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 groupThe physical conditioning program included a total of three 50-55 minute sessions per week. Pregnant women started at 9 weeks and finished at 38-39 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate. Each session included 10 min of warm up and 10 min of cool down which included an specific pelvic floor muscles training. The core section of the exercise session lasted from 25 to 30 min and included moderate-intensity aerobic exercises once a week and resistance exercises twice a week. | Behavioural | Exercise group |
Primary outcome
Maternal gestational weight gain
Time frame: 40-42 weeks
Maternal weight gain
2 secondary outcomes
Maternal gestational diabetes
Time frame: From 24 to 26 week
Fetal body mass index
Time frame: 38-42 weeks
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 14 Mar 2013.
- Derived from this study: PubMed 24290112Ruiz JR, Perales M, Pelaez M, Lopez C, Lucia A, Barakat R. Supervised exercise-based intervention to prevent excessive gestational weight gain: a randomized controlled trial. Mayo Clin Proc. 2013 Dec;88(12):1388-97. doi: 10.1016/j.mayocp.2013.07.020.
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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.
Ruben Barakat, PhD study director
Universidad Politecnica de 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 2 inclusion and 4 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 14 Mar 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?
Maternal gestational weight gain (time frame: 40-42 weeks). 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 NCT01790347, 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 14 Mar 2013.