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Physical Exercise Program in Obese and Overweight Pregnant Women

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ClinicalTrials.gov Identifier: NCT01753622
Recruitment Status : Unknown
Verified December 2012 by María Perales Santaella, Technical University of Madrid.
Recruitment status was:  Recruiting
First Posted : December 20, 2012
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
María Perales Santaella, Technical University of Madrid

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pregnancy Behavioral: Exercise group Not Applicable

Detailed Description:
The aim of our study is to assess whether a specific exercise program during pregnancy has a positive effect on maternal mood and other pregnancy outcomes.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of a Supervised Exercise Program in Obese and Overweight Pregnant Women on Outcomes and Level of Depression. A Randomized Controlled Trial
Study Start Date : October 2009
Actual Primary Completion Date : January 2013
Estimated Study Completion Date : November 2015

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control group
Sedentary Obese and overweight pregnant women
Experimental: Exercise group
Physical exercise program
 Behavioral: Exercise group

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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from level of depression at the end of the pregnancy [ Time Frame: Up to 36 weeks ]
    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


Secondary Outcome Measures :
  1. Maternal gestational weight gain [ Time Frame: 40-42 weeks ]
    Maternal gain weight

  2. Maternal outcomes [ Time Frame: After labor ]
    Type of labor


Other Outcome Measures:
  1. Fetal weight [ Time Frame: After labor ]
    Birth weight (g.)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753622


Contacts
Contact: María Perales, PhD student 913364081 m.perales.santaella@gmail.com
Contact: Ruben Barakat, PhD 913364020 barakatruben@gmail.com

Locations
Spain
Universidad Politecnica de Madrid Recruiting
Madrid, Spain, 28040
Contact: Maria Perales, PhD student    913364081    m.perales.santaella@gmail.com   
Contact: Ruben Barakat, PhD    913364020    barakatruben@gmail.com   
Principal Investigator: Maria Perales, PhD student         
Sponsors and Collaborators
Technical University of Madrid
Investigators
Study Director: Rubén Barakat, PhD Universidad Politécnica de Madrid
More Information
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Responsible Party: María Perales Santaella, PhD student, Technical University of Madrid
ClinicalTrials.gov Identifier: NCT01753622     History of Changes
Other Study ID Numbers: Overweight-obese pregnant
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: December 2012

Keywords provided by María Perales Santaella, Technical University of Madrid:
Overweight, obese, pregnant, depression, outcomes

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms