PregnancyNCT01477372
Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences
A study testing Supervised exercise program in people with Pregnancy, run by Universidad Politecnica de Madrid at 1 site in Spain.
Trial summary
The purpose of this study was to assess the effectiveness of a moderated physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Supervised exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2007to Feb 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women
- Delivering in "Hospital Universitario de Fuenlabrada"
- At week 10-14 of gestation
- Able to attend 3 sessions per week until the end of the pregnancy
Who cannot join
- Contraindications appointed by ACOG
- Less than 56 sessions
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to assess the effectiveness of a moderated physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes and on the perception of the pregnant's health
Read the detailed description
BACKROUND: Pregnancy and delivery can condition significantly women's health. In particular, an excessive gain of weight during pregnancy constitutes a risk factor which may lead to (i) different alterations during pregnancy such as gestational diabetes or hypertension, (ii) foetus health problems (macrosomia), (iii) delivery complications (dystocia, prolonged labour and increased number of caesareans) and (iv) future health disorders for the woman (overweight, obesity and cardiovascular alterations). Furthermore, during pregnancy pelvic floor health problems, such as urinary incontinence (IU) may arise or worsen.
OBJECTIVES: The main aim of this study was to assess the effectiveness of a moderate physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes (maternal and foetal) and on the perception of the pregnant's health.
DESIGN: A randomized, controlled trial called has been conducted. 300 healthy pregnant women were recruited and divided into an intervention group (IG, n=100) and a control group (CG, n=200). The IG participated in BEP as from week 10-12 of gestation (at least 56 sessions through 22 weeks. 3 sessions per week). The CG did not participate in any supervised program addressed to pregnant women but received regular health care. Pregnancy outcomes regarding the mother and the new born, urinary incontinence and women's habits data were obtained and registered through initial interviews, medical records and two specific questionnaires on health and urinary incontinency (ICIQ-SF and King's).
- Conditions
- Pregnancy
- Being tested
- Supervised exercise program
- Keywords
- Pregnancy, Exercise, Excessive weight gain, Outcomes, Urinary incontinence
- Medical subject headings
- Motor Activity, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise programBehavioural
Intervention group participated in Blooming Exercise Program as from week 10-12 of gestation. At least 56 sessions through 22 weeks. 3 sessions per week
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Supervised exercise program Receives: Behavioral: Supervised exercise program |
| Control | No intervention | Sedentary pregnant woman |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal weight gain
Maternal weight gain and proportion of participants exceeding weight gain above IOM (2009) recommendations
Measured: week 36-38 of gestation
Secondary outcomes (3)
Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery)
Measured: week 36-38 of gestation
Urinary incontinence
Measured: week 36-38 of gestation
Other pregnancy outcomes (maternal and foetal)
Measured: week 36-38 of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startSep 2007
- Primary completionFeb 2011
- Study completionFeb 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruben Barakat Carballo, Universidad Politecnica de Madrid
- Investigators
- Ruben O Barakat, PhD, Study director, Universidad Politecnica de MadridMireia Peláez, PhD, Principal investigator, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477372
- Sponsor's protocol ID
- 240/09
- Status last verified
- Apr 2012
- First submitted
- 22 Sep 2011
- Last updated
- 11 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pelaez M, Gonzalez-Cerron S, Montejo R, Barakat R. Protective Effect of Exercise in Pregnant Women Including Those Who Exceed Weight Gain Recommendations: A Randomized Controlled Trial. Mayo Clin Proc. 2019 Oct;94(10):1951-1959. doi: 10.1016/j.mayocp.2019.01.050.
PubMed 31585579
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences
- ClinicalTrials.gov ID
- NCT01477372
- Acronym / sponsor ID
- 240/09
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Exercise, Excessive weight gain, Outcomes, Urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 22 Nov 2011 (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 this study was to assess the effectiveness of a moderated physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes and on the perception of the pregnant's health
Detailed description
BACKROUND: Pregnancy and delivery can condition significantly women's health. In particular, an excessive gain of weight during pregnancy constitutes a risk factor which may lead to (i) different alterations during pregnancy such as gestational diabetes or hypertension, (ii) foetus health problems (macrosomia), (iii) delivery complications (dystocia, prolonged labour and increased number of caesareans) and (iv) future health disorders for the woman (overweight, obesity and cardiovascular alterations). Furthermore, during pregnancy pelvic floor health problems, such as urinary incontinence (IU) may arise or worsen.
OBJECTIVES: The main aim of this study was to assess the effectiveness of a moderate physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes (maternal and foetal) and on the perception of the pregnant's health.
DESIGN: A randomized, controlled trial called has been conducted. 300 healthy pregnant women were recruited and divided into an intervention group (IG, n=100) and a control group (CG, n=200). The IG participated in BEP as from week 10-12 of gestation (at least 56 sessions through 22 weeks. 3 sessions per week). The CG did not participate in any supervised program addressed to pregnant women but received regular health care. Pregnancy outcomes regarding the mother and the new born, urinary incontinence and women's habits data were obtained and registered through initial interviews, medical records and two specific questionnaires on health and urinary incontinency (ICIQ-SF and King's).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Supervised exercise programSupervised exercise program |
| Control | No intervention | –Sedentary pregnant woman |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy pregnant women
- Delivering in "Hospital Universitario de Fuenlabrada"
- At week 10-14 of gestation
- Able to attend 3 sessions per week until the end of the pregnancy
Key exclusion criteria (2 listed)
- Contraindications appointed by ACOG
- Less than 56 sessions
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 |
|---|---|---|
| Supervised exercise programIntervention group participated in Blooming Exercise Program as from week 10-12 of gestation. At least 56 sessions through 22 weeks. 3 sessions per week | Behavioural | Exercise group |
Primary outcome
Maternal weight gain
Time frame: week 36-38 of gestation
Maternal weight gain and proportion of participants exceeding weight gain above IOM (2009) recommendations
3 secondary outcomes
Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery)
Time frame: week 36-38 of gestation
Urinary incontinence
Time frame: week 36-38 of gestation
Other pregnancy outcomes (maternal and foetal)
Time frame: week 36-38 of gestation
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 11 Apr 2012.
- Derived from this study: PubMed 31585579Pelaez M, Gonzalez-Cerron S, Montejo R, Barakat R. Protective Effect of Exercise in Pregnant Women Including Those Who Exceed Weight Gain Recommendations: A Randomized Controlled Trial. Mayo Clin Proc. 2019 Oct;94(10):1951-1959. doi: 10.1016/j.mayocp.2019.01.050.
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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 O Barakat, PhD study director
Universidad Politecnica de Madrid
Mireia Peláez, PhD principal investigator
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 Supervised exercise program in people with Pregnancy, run by Universidad Politecnica de 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 4 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 11 Apr 2012. 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 weight gain (time frame: week 36-38 of gestation). 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 NCT01477372, 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 Apr 2012.