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临床试验/NCT01136291
NCT01136291已完成不适用

Physical Exercise Influence on Maternal, Perinatal Outcomes and Quality of Life Among Overweight and Obese Pregnant Women:

University of Campinas, Brazil4 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2008年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
4
主要终点
Gestational Weight Gain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Gestational Weight Gain

时间窗: baseline and at 40 gestational weeks

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

时间窗: at the 14 to 40 gestational weeks

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

次要结局

  • Quality of Life Through World Health Organization Quality of Life Abbreviated Questionnaire WHOQOL-Bref)(at the 14 and at the 40 gestational weeks)

研究者

发起方
University of Campinas, Brazil
申办方类型
Other

研究点 (4)

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