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临床试验/NCT00273572
NCT00273572已完成不适用

The Effect of a Lifestyle Intervention Program on Parameters of the Metabolic Syndrome Among Non-Diabetic Obese Arab Women

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2004年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Parameters of the metabolic syndrome

研究概览

简要总结

The study protocol aims to test the hypothesis that a lifestyle intervention program aimed to increase leisure-time physical activity and reduce body weight will improve the parameters of the metabolic syndrome and quality of life among obese, non-diabetic Arab women

详细描述

200 obese non-diabetic Arab women, 35-54 years old, with one or more parameters of the metabolic syndrome (NCEP-III criteria) will be randomized to either conventional or intensive treatment. The intensive intervention arm will include group meetings with physical education instructor (twice a month),group meetings with a dietician (once per month) and personal dietary counselling (once per month). The targets to be achieved will be at least 7% reduction of the initial body weight and engagement in leisure-time sports activity for at least 150 min/week.Evaluation before enrollment and at the end of the trial will include: information on dietary and physical activity habits, quality of life parameters, anthropometric and blood pressure measurement, blood lipid profile, and fasting and post oral glucose load blood glucose and insulin levels. Duration of the intervention: 12 month.

研究设计

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

入排标准

年龄范围
35 Years 至 54 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Obesity (BMI: 30-40 kg/squared meter)
  • Female Gender
  • Being 35-54 years old

排除标准

  • A contraindication for physical activity

结局指标

主要结局

Parameters of the metabolic syndrome

时间窗: At baseline, and after 6 and 12 months

次要结局

  • Quality of life(At baseline, and after 12 months)
  • Attainment of weight reduction and physical activity targets(At baseline, and after 6 and 12 months)

研究者

申办方类型
Other Gov

研究点 (2)

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