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Physical Exercise Program in Obese and Overweight Pregnant Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Technical University of Madrid
Sponsor:
Information provided by (Responsible Party):
María Perales Santaella, Technical University of Madrid
ClinicalTrials.gov Identifier:
NCT01753622
First received: December 17, 2012
Last updated: November 13, 2014
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Pregnancy
 Behavioral: Exercise group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Technical University of Madrid:

Primary Outcome Measures:
  • Change from level of depression at the end of the pregnancy [ Time Frame: Up to 36 weeks ] [ Designated as safety issue: No ]
    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:
  • Maternal gestational weight gain [ Time Frame: 40-42 weeks ] [ Designated as safety issue: No ]
    Maternal gain weight

  • Maternal outcomes [ Time Frame: After labor ] [ Designated as safety issue: No ]
    Type of labor


Other Outcome Measures:
  • Fetal weight [ Time Frame: After labor ] [ Designated as safety issue: No ]
    Birth weight (g.)
Estimated Enrollment: 150
Study Start Date: October 2009
Estimated Study Completion Date: November 2015
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility
Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 17, 2012
Last Updated: November 13, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on March 01, 2015