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Physical Exercise Influence Among Overweight and Obese Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01136291
Recruitment Status : Completed
First Posted : June 3, 2010
Results First Posted : February 23, 2011
Last Update Posted : March 23, 2011
Sponsor:
Information provided by:
University of Campinas, Brazil

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions Obesity
Overweight
Intervention Other: physical exercise
Enrollment 82
Recruitment Details 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 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).
Arm/Group Title Physical Exercise no Exercise
Hide Arm/Group Description

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.

The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
Period Title: Overall Study
Started 40 42
Follow 40 42
Completed 39 41
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Physical Exercise no Exercise Total
Hide Arm/Group Description

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.

The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling. Total of all reporting groups
Overall Number of Baseline Participants 40 42 82
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 42 participants 82 participants
29.7  (6.8) 30.9  (5.9) 30.1  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 42 participants 82 participants
Female
40
 100.0%
42
 100.0%
82
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 40 participants 42 participants 82 participants
40 42 82
1.Primary Outcome
Title Gestational Weight Gain
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Physical Exercise no Exercise
Hide Arm/Group Description:

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.

The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
Overall Number of Participants Analyzed 40 42
Mean (Standard Deviation)
Unit of Measure: kg
10.3  (5.0) 11.5  (7.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Physical Exercise, no Exercise
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
2.Primary Outcome
Title Weight Gain During the Program
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Physical Exercise no Exercise
Hide Arm/Group Description:

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.

The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
Overall Number of Participants Analyzed 40 42
Mean (Standard Deviation)
Unit of Measure: kg
7.7  (4.3) 8.1  (4.3)
3.Secondary Outcome
Title Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Physical Exercise no Exercise
Hide Arm/Group Description:

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.

The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
Overall Number of Participants Analyzed 40 42
Mean (Standard Deviation)
Unit of Measure: scores on a scale
49.8  (17.1) 42.2  (16.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Physical Exercise no Exercise
Hide Arm/Group Description

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.

The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
All-Cause Mortality
Physical Exercise no Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Physical Exercise no Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/42 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Physical Exercise no Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/42 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Fernanda Garanhani de Castro Surita
Organization: Department of Obstetrics and Gynecology - University of Campinas
Phone: +551935219304
EMail: surita@unicamp.br
Layout table for additonal information
Responsible Party: University of Campinas, Departamento de tocoginecologia
ClinicalTrials.gov Identifier: NCT01136291    
Other Study ID Numbers: exerciseobesitypregnancy
First Submitted: May 21, 2010
First Posted: June 3, 2010
Results First Submitted: December 10, 2010
Results First Posted: February 23, 2011
Last Update Posted: March 23, 2011