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Physical Exercise Influence Among Overweight and Obese Pregnant Women

This study has been completed.
Sponsor:
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01136291
First received: May 21, 2010
Last updated: March 20, 2011
Last verified: March 2011
History of Changes
Results First Received: December 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Obesity
Overweight
Intervention: Other: physical exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A randomized controlled clinical trial was conducted with pregnant women seen at the Prenatal Outpatient Clinic of the Women’s Integral Healthcare Center (CAISM-UNICAMP) from August 2008 to August 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The entire study protocol was explained to these women and a written informed consent term was obtained. Subsequently, the women were randomly assigned to two groups: 1) one exercised under supervision and received home exercise counseling (study group) and 2) the other followed the prenatal routine of the service (control group).

Reporting Groups
  Description
Physical Exercise

The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.

The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.

These women also received nutrition and prenatal care.
no Exercise The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.

Participant Flow:   Overall Study
    Physical Exercise     no Exercise  
STARTED     40     42  
Follow     40     42  
COMPLETED     39     41  
NOT COMPLETED     1     1  
Lost to Follow-up                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Physical Exercise

The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.

The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.

These women also received nutrition and prenatal care.
no Exercise The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
Total Total of all reporting groups

Baseline Measures
    Physical Exercise     no Exercise     Total  
Number of Participants  
[units: participants]
 		  40     42     82  
Age  
[units: years]
Mean ± Standard Deviation 		  29.7  ± 6.8     30.9  ± 5.9     30.1  ± 6.2  
Gender  
[units: participants]
 		     
Female     40     42     82  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
Brazil     40     42     82  



  Outcome Measures
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1.  Primary:   Gestational Weight Gain   [ Time Frame: baseline and at 40 gestational weeks ]
  Show Outcome Measure 1

2.  Primary:   Weight Gain During the Program   [ Time Frame: at the 14 to 40 gestational weeks ]
  Show Outcome Measure 2

3.  Secondary:   Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)   [ Time Frame: at the 14 and at the 40 gestational weeks ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Fernanda Garanhani de Castro Surita
Organization: Department of Obstetrics and Gynecology - University of Campinas
phone: +551935219304
e-mail: surita@unicamp.br


No publications provided


Responsible Party: University of Campinas, Departamento de tocoginecologia
ClinicalTrials.gov Identifier: NCT01136291     History of Changes
Other Study ID Numbers: exerciseobesitypregnancy
Study First Received: May 21, 2010
Results First Received: December 10, 2010
Last Updated: March 20, 2011
Health Authority: Brazil: National Committee of Ethics in Research