Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences
Primary Purpose
Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Supervised exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy focused on measuring Pregnancy, Exercise, Excessive weight gain, Outcomes, Urinary incontinence
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Contraindications appointed by ACOG
- Less than 56 sessions
Sites / Locations
- Universitarian Hospital of Fuenlabrada
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise group
Control
Arm Description
Supervised exercise program
Sedentary pregnant woman
Outcomes
Primary Outcome Measures
Maternal weight gain
Maternal weight gain and proportion of participants exceeding weight gain above IOM (2009) recommendations
Secondary Outcome Measures
Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery)
Urinary incontinence
Other pregnancy outcomes (maternal and foetal)
Full Information
NCT ID
NCT01477372
First Posted
September 22, 2011
Last Updated
April 10, 2012
Sponsor
Universidad Politecnica de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT01477372
Brief Title
Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences
Official Title
Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Politecnica de Madrid
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Pregnancy, Exercise, Excessive weight gain, Outcomes, Urinary incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Supervised exercise program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Sedentary pregnant woman
Intervention Type
Behavioral
Intervention Name(s)
Supervised exercise program
Intervention Description
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
Primary Outcome Measure Information:
Title
Maternal weight gain
Description
Maternal weight gain and proportion of participants exceeding weight gain above IOM (2009) recommendations
Time Frame
week 36-38 of gestation
Secondary Outcome Measure Information:
Title
Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery)
Time Frame
week 36-38 of gestation
Title
Urinary incontinence
Time Frame
week 36-38 of gestation
Title
Other pregnancy outcomes (maternal and foetal)
Time Frame
week 36-38 of gestation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Contraindications appointed by ACOG
Less than 56 sessions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben O Barakat, PhD
Organizational Affiliation
Universidad Politécnica de Madrid.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mireia Peláez, PhD
Organizational Affiliation
Universidad Politécnica de Madrid.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitarian Hospital of Fuenlabrada
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
31585579
Citation
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.
Results Reference
derived
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Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences
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