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临床试验/NCT01358773
NCT01358773Unknown早期 1 期

Multiprofessional Impact on Body Composition, Central and Peripheric Adiposity, Lipid Profile, Hormonal Regulation, Lung, Sleep and Humor Disorders in Adolescents

Ana R. Damaso1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2004年2月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
发起方
入组人数
150
试验地点
1
主要终点
Body composition

研究概览

简要总结

Obese adolescents are submitted to a multiprofessional weight loss program, which is formed by doctors, nutritionists, physiotherapists, psychologists,and physiologists. The volunteers have intervention 3 times a week during one year, where they practice exercises, have nutrition and psychology counseling, and physiotherapy orientation. Once a month they have an appointment with the doctor. The hypothesis of this study is that a multiprofessional therapy is able to improve anthropometric and biochemical parameters, and also the quality of life of obese adolescents.

详细描述

The volunteers are submitted to 10 exams (electrocardiogram, polysomnography, blood collection, body composition, rest metabolic rate, DXA, abdominal and carotid ultrasonography, lung function evaluation, ergospirometric test) 3 times a year (baseline, middle and at the end of the year). They also answer nutrition, sleep and psychology questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •present obesity ( BMI > 95th)
  • •aged between 15-19 years old
  • •be able to practice exercise

排除标准

  • •pregnancy
  • •use of drugs
  • •secondary obesity

研究组 & 干预措施

Lifestyle counseling

Other

Obese adolescents are encouraged to improve their lifestyle

干预措施: multidisciplinary intervention (Other)

结局指标

主要结局

Body composition

时间窗: six months

The body composition was measured by plethysmography and by densitometry.

次要结局

  • visceral and subcutaneous fat were analyzed by ultrasound(six months)
  • Serum analysis(six months)
  • Sleep parameters(six months)
  • Lung function(six months)
  • Arterial intima-media thickness(six months)

研究者

发起方
Ana R. Damaso
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ana R. Damaso

Associated Professor

Federal University of São Paulo

研究点 (1)

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