Physical Exercise Influence Among Overweight and Obese Pregnant Women
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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: |
- 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
- 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 |
- 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| Brazil | |
| Centro de atenção integral à saúde da mulher - CAISM | |
| Campinas, São Paulo, Brazil, 13083881 | |
| Centro de Atenção Integral à saúde da mulher | |
| Campinas, São Paulo, Brazil, 13083811 | |
| 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 Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013