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Physical Exercise Influence Among Overweight and Obese Pregnant Women

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
physical exercise
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring pregnancy, obesity, physical exercise, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers
  • Overweight or obese (BMI ≥ 26 kg / m²),
  • Gestational age between 14 and 24 weeks and from age 18 years
  • No contraindication for physical exercise on pregnancy

Sites / Locations

  • Centro de Atenção Integral à saúde da mulher
  • Centro de atenção integral à saúde da mulher - CAISM

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

physical exercise

no exercise

Arm Description

exercise on obese and overweight pregnant women, routine prenatal care and nutritional counseling

Routine prenatal care and nutritional counseling. No exercise

Outcomes

Primary Outcome Measures

Gestational Weight Gain
Gestational weight gain is the difference between the prepregnancy weight and the last weight measure at the end of pregnancy
Weight Gain During the Program
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

Secondary Outcome Measures

Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)
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).

Full Information

First Posted
May 21, 2010
Last Updated
March 20, 2011
Sponsor
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01136291
Brief Title
Physical Exercise Influence Among Overweight and Obese Pregnant Women
Official Title
Physical Exercise Influence on Maternal, Perinatal Outcomes and Quality of Life Among Overweight and Obese Pregnant Women:
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective: To evaluate the association between physical exercise for obese or overweight women and the maternal, perinatal outcomes and perception of these women about their quality of life. Methods: A randomized controlled clinical trial with 78 pregnant women. Overweight or obese (BMI ≥ 26 kg / m²), gestational age between 14 and 24 weeks and from age 18 years were included. They will be divided into two random groups: one which will an exercise program under supervision and guidance received from home exercises (study group) and another that followed the standard routine prenatal care service (control group). Both groups will receive standardized nutritional counseling by the department of nutrition and dietetics and a questionnaire measuring quality of life WHOQOL-short at 14 - 24 weeks and at 36 weeks of pregnancy. The intervention results will be analyzed by intention to treat. A P value less than 0.05 will be used to determine statistical significance.
Detailed Description
Objective: To evaluate the association between physical exercise for obese or overweight women and the maternal, perinatal outcomes and perception of these women about their quality of life. Methods: A randomized controlled clinical trial with 78 pregnant women. Overweight or obese (BMI ≥ 26 kg / m²), gestational age between 14 and 24 weeks and from age 18 years were included. They will be divided into two random groups: one which will an exercise program under supervision and guidance received from home exercises (study group) and another that followed the standard routine prenatal care service (control group). Both groups will receive standardized nutritional counseling by the department of nutrition and dietetics and a questionnaire measuring quality of life WHOQOL-short at 14 - 24 weeks and at 36 weeks of pregnancy. The intervention results will be analyzed by intention to treat. A P value less than 0.05 will be used to determine statistical significance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
pregnancy, obesity, physical exercise, quality of life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physical exercise
Arm Type
Other
Arm Description
exercise on obese and overweight pregnant women, routine prenatal care and nutritional counseling
Arm Title
no exercise
Arm Type
No Intervention
Arm Description
Routine prenatal care and nutritional counseling. No exercise
Intervention Type
Other
Intervention Name(s)
physical exercise
Intervention 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 counseling and prenatal care.
Primary Outcome Measure Information:
Title
Gestational Weight Gain
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
Title
Weight Gain During the Program
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
Secondary Outcome Measure Information:
Title
Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Overweight or obese (BMI ≥ 26 kg / m²), Gestational age between 14 and 24 weeks and from age 18 years No contraindication for physical exercise on pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda Surita, MD, PhD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Atenção Integral à saúde da mulher
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083811
Country
Brazil
Facility Name
Centro de atenção integral à saúde da mulher - CAISM
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13083881
Country
Brazil

12. IPD Sharing Statement

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Physical Exercise Influence Among Overweight and Obese Pregnant Women

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