Clinical trial NCT01136291: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: pregnancy
obesity
physical exercise
quality of life
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Gestational Weight Gain
timeFrame: baseline and at 40 gestational weeks
measure: Weight Gain During the Program
timeFrame: at the 14 to 40 gestational weeks
Secondary outcomes:
measure: Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)
timeFrame: at the 14 and at the 40 gestational weeks
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Centro de Atenção Integral à saúde da mulher
state: São Paulo
city: Campinas
country: Brazil
facility: Centro de atenção integral à saúde da mulher - CAISM
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Fernanda Surita, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: