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
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
  Hide Participant Flow

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


  Outcome Measures
  Hide All Outcome Measures

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

Measure Type Primary
Measure Title Gestational Weight Gain
Measure Description Gestational weight gain is the difference between the prepregnancy weight and the last weight measure at the end of pregnancy
Time Frame baseline and at 40 gestational weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.

Measured Values
    Physical Exercise     no Exercise  
Number of Participants Analyzed  
[units: participants]
  40     42  
Gestational Weight Gain  
[units: kg]
Mean ± Standard Deviation
  10.3  ± 5.0     11.5  ± 7.4  


Statistical Analysis 1 for Gestational Weight Gain
Groups [1] All groups
Method [2] t-test, 1 sided
P Value [3] <0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The homogeneity between the groups was compared by the Student’s t test or the Mann-Whitney test for continuous variables and chi-square for categorical variables.A comparison between values before and after the study group session was performed by the Student’s t test. The effect of the exercise was evaluated by repeated measures ANOVA, where the effect of time and group were evaluated on pressure, weight, Body Mass Index (BMI)and World Health Organization Quality of Life Questionnarie domains.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Primary
Measure Title Weight Gain During the Program
Measure Description Weight gain during the program was the difference between the weight measured at study entry and final consultation weight, measured by a mechanical scale, in kilos and grams
Time Frame at the 14 to 40 gestational weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.

Measured Values
    Physical Exercise     no Exercise  
Number of Participants Analyzed  
[units: participants]
  40     42  
Weight Gain During the Program  
[units: kg]
Mean ± Standard Deviation
  7.7  ± 4.3     8.1  ± 4.3  

No statistical analysis provided for Weight Gain During the Program



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 ]

Measure Type Secondary
Measure Title Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)
Measure Description All pregnant women responded to the quality of life WHOQOL-bref questionnaire, at study inclusion and at the completion of 36 gestational weeks. The domains of these questionnaires were calculated on a scale of zero (the worse quality of life) to 100 points (the better quality of life).
Time Frame at the 14 and at the 40 gestational weeks  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.

Measured Values
    Physical Exercise     no Exercise  
Number of Participants Analyzed  
[units: participants]
  40     42  
Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)  
[units: scores on a scale]
Mean ± Standard Deviation
  49.8  ± 17.1     42.2  ± 16.1  

No statistical analysis provided for Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)




  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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