Physical Exercise Influence Among Overweight and Obese Pregnant Women

NCT ID: NCT01136291

Last Updated: 2011-03-23

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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physical exercise

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

Group Type OTHER

physical exercise

Intervention Type OTHER

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.

no exercise

Routine prenatal care and nutritional counseling. No exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 counseling and prenatal care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Departamento de tocoginecologia

Principal Investigators

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Fernanda Surita, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Campinas, Brazil

Locations

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Centro de Atenção Integral à saúde da mulher

Campinas, São Paulo, Brazil

Site Status

Centro de atenção integral à saúde da mulher - CAISM

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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exerciseobesitypregnancy

Identifier Type: -

Identifier Source: org_study_id

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