Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences
1 other identifier
interventional
320
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pregnancy
Started Sep 2007
Typical duration for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 22, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedApril 11, 2012
April 1, 2012
3.4 years
September 22, 2011
April 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maternal weight gain
Maternal weight gain and proportion of participants exceeding weight gain above IOM (2009) recommendations
week 36-38 of gestation
Secondary Outcomes (3)
Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery)
week 36-38 of gestation
Urinary incontinence
week 36-38 of gestation
Other pregnancy outcomes (maternal and foetal)
week 36-38 of gestation
Study Arms (2)
Exercise group
EXPERIMENTALSupervised exercise program
Control
NO INTERVENTIONSedentary pregnant woman
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Contraindications appointed by ACOG
- Less than 56 sessions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitarian Hospital of Fuenlabrada
Fuenlabrada, Madrid, 28942, Spain
Related Publications (1)
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.
PMID: 31585579DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ruben O Barakat, PhD
Universidad Politecnica de Madrid
- PRINCIPAL INVESTIGATOR
Mireia Peláez, PhD
Universidad Politecnica de Madrid
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
September 22, 2011
First Posted
November 22, 2011
Study Start
September 1, 2007
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
April 11, 2012
Record last verified: 2012-04