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Physical Exercise Controls Gestational Weight Gain

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ClinicalTrials.gov Identifier: NCT01790347
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : March 14, 2013
Sponsor:
Information provided by (Responsible Party):
María Perales Santaella, Technical University of Madrid

Brief Summary:
An estimated two-thirds to three- quarters of women experience gestational weight gain outside of IOM's 2009 recommendations: 40-60% of women experiencing excessive gain and 15-30% inadequate gain. Not gaining the adequate weight gain is strongly associated with several maternal and fetal complications..

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

Detailed Description:
The aim of this study was to assess the role of a supervised exercise programme on the control of maternal gestational weight gain and its consequences.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Role of a Supervised Physical Exercise Program as a Alternative on the Control of Maternal Gestational Weight Gain
Study Start Date : September 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise group Behavioral: Exercise group

The physical conditioning program included a total of three 50-55 minute sessions per week. Pregnant women started at 9 weeks and finished at 38-39 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate.

Each session included 10 min of warm up and 10 min of cool down which included an specific pelvic floor muscles training. The core section of the exercise session lasted from 25 to 30 min and included moderate-intensity aerobic exercises once a week and resistance exercises twice a week.


No Intervention: Control group
Sedentary pregnant women



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


Secondary Outcome Measures :
  1. Maternal gestational diabetes [ Time Frame: From 24 to 26 week ]
    Gestational diabetes

  2. Fetal body mass index [ Time Frame: 38-42 weeks ]
    Baby body Mass index (BMI)


Other Outcome Measures:
  1. Gestational age [ Time Frame: 36-42 weeks ]
    Number of weeks of gestation at labor

  2. Fetal outcome [ Time Frame: 36-42 weeks ]
    Type of labor



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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

Exclusion Criteria:

  • Obstetrician complications
  • Being interested in the study after 18 weeks
  • Not being regular in physical exercise program
  • Younger than 18 years old

Information from the National Library of Medicine

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): NCT01790347


Locations
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Spain
Universidad Politécnica de Madrid
Madrid, Spain, 28040
Sponsors and Collaborators
Technical University of Madrid
Investigators
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Study Director: Ruben Barakat, PhD Universidad Politécnica de Madrid

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: María Perales Santaella, PhD student, Technical University of Madrid
ClinicalTrials.gov Identifier: NCT01790347     History of Changes
Other Study ID Numbers: Gestational weight gain
First Posted: February 13, 2013    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: January 2013

Keywords provided by María Perales Santaella, Technical University of Madrid:
Exercise
Aerobic
Resistance training
Pregnancy
Maternal weight gain
IOM recommendations

Additional relevant MeSH terms:
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Weight Gain
Gestational Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms