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
  Purpose

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.


Condition Intervention
Obesity
Overweight
Other: physical exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Physical Exercise Influence on Maternal, Perinatal Outcomes and Quality of Life Among Overweight and Obese Pregnant Women:

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Gestational Weight Gain [ Time Frame: baseline and at 40 gestational weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at the 14 to 40 gestational weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: at the 14 and at the 40 gestational weeks ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 82
Study Start Date: August 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
physical exercise
exercise on obese and overweight pregnant women, routine prenatal care and nutritional counseling
Other: 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.

No Intervention: no exercise
Routine prenatal care and nutritional counseling. No exercise

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136291

Locations
Brazil
Centro de Atenção Integral à saúde da mulher
Campinas, São Paulo, Brazil, 13083811
Centro de atenção integral à saúde da mulher - CAISM
Campinas, São Paulo, Brazil, 13083881
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Principal Investigator: Fernanda Surita, MD, PhD University of Campinas, Brazil
  More Information

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

Keywords provided by University of Campinas, Brazil:
pregnancy
obesity
physical exercise
quality of life

Additional relevant MeSH terms:
Obesity
Overweight
Body Weight
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014