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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

May 21, 2010
March 20, 2011
August 2008
August 2010   (final data collection date for primary outcome measure)
  • 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
gestational weight gain [ Time Frame: After 14 weeks of pregnancy ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01136291 on ClinicalTrials.gov Archive Site
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).
quality of life [ Time Frame: fistly at14 - 24 weeks and at 36 weeks of pregnancy ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Physical Exercise Influence Among Overweight and Obese Pregnant Women
Physical Exercise Influence on Maternal, Perinatal Outcomes and Quality of Life Among Overweight and Obese Pregnant Women:

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Obesity
  • Overweight
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.

  • physical exercise
    exercise on obese and overweight pregnant women, routine prenatal care and nutritional counseling
    Intervention: Other: physical exercise
  • No Intervention: no exercise
    Routine prenatal care and nutritional counseling. No exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
August 2010
August 2010   (final data collection date for primary outcome measure)
  • 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01136291
exerciseobesitypregnancy
No
University of Campinas, Departamento de tocoginecologia
University of Campinas, Brazil
Not Provided
Principal Investigator: Fernanda Surita, MD, PhD University of Campinas, Brazil
University of Campinas, Brazil
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP