Physical Exercise Program in Obese and Overweight Pregnant Women
Effect of a Supervised Exercise Program in Obese and Overweight Pregnant Women on Outcomes and Level of Depression. A Randomized Controlled Trial
1 other identifier
interventional
150
1 country
1
Brief Summary
Obesity and overweight have become an epidemic in the world and its prevalence between pregnant women is especially dangerous. Having a high Body Mass Index (BMI) is also associated with depression disorders and its serious complications during this period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pregnancy
Started Oct 2009
Longer than P75 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
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 17, 2012
CompletedFirst Posted
Study publicly available on registry
December 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedNovember 14, 2014
December 1, 2012
3.3 years
December 17, 2012
November 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from level of depression at the end of the pregnancy
The Center for Epidemiological Studies-Depression scale (CES-D) was administered to all obese and overweight pregnant women at the beginning and at the end of their pregnancies
Up to 36 weeks
Secondary Outcomes (2)
Maternal gestational weight gain
40-42 weeks
Maternal outcomes
After labor
Other Outcomes (1)
Fetal weight
After labor
Study Arms (2)
Control group
NO INTERVENTIONSedentary Obese and overweight pregnant women
Exercise group
EXPERIMENTALPhysical exercise program
Interventions
Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise, 10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training. Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate.
Eligibility Criteria
You may qualify if:
- Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
- Being able to communicate in spanish
- Giving birth at Hospital Universitario de Fuenlabrada
- Having a Body Mass Index (BMI) greater than 24.9
You may not qualify if:
- Multiparity
- Obstetrician complications
- Being interested in the study after 18 weeks
- Not being regular in physical exercise program (minimum adherence 80%)
- Younger than 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Politecnica de Madrid
Madrid, Madrid, 28040, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rubén Barakat, PhD
Universidad Politecnica de Madrid
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
December 17, 2012
First Posted
December 20, 2012
Study Start
October 1, 2009
Primary Completion
January 1, 2013
Study Completion
November 1, 2015
Last Updated
November 14, 2014
Record last verified: 2012-12