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临床试验/NCT00409422
NCT00409422已完成不适用

Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children

Yale University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2002年5月1日最近更新:
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
weight

研究概览

简要总结

To compare anthropometric and metabolic effects of a comprehensive weight management program on obese adolescents and children in comparison to regular clinical weight management visits.

详细描述

Patients are randomized (2:1) to either the intensive or standard treatment (control). Those who get randomized into the intensive group go to a family-based weight management program, including exercise, nutrition, behavior modification, and parenting classes. The intensive group is further randomized into a diet or non-dieting class to compare the outcomes of two different nutrition intervention methods. These classes meet twice per week (exercise twice per week and nutrition/behavior modification once per week)for first six months and then only twice per month during last six months. An exercise physiologist supervises the exercise component, which involves 45 minutes of aerobic activity (targeted at 65 to 80 percent of the subject's estimated maximum heart rate. A registered dietitian facilitates the nutrition and behavior component. A social worker facilitates parent classes when the children have a behavior modification topic in their class (parents only attend nutrition sessions). Those who get randomized into the control group go to clinic visits every 6 months. Intervention subjects go to clinic, as well, every 6 months to obtain the same measurements as the controls (weight, BMI, % fat, fasting insulin, fasting glucose, lipids, blood pressure).

研究设计

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

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages 8-16 years old
  • BMI >95th percentile for age/gender based on CDC
  • Both primary caregiver/parent and child must agree to participate in the nutrition classes

排除标准

  • endocrinopathies, including hypothyroidism and diabetes
  • Psychiatric disorders that will interfere with ability to complete follow-up and adherence to protocol
  • Any behavioral or psychosocial issue that will interfere with subject's completion of program, including eating disorder.
  • Any use of medication (steroids, for ex.) that contributes to excess adiposity.
  • Any use of pharmacological intervention for weight management, including prescription medications, over-the-counter medications, or herbal supplements.
  • Any concurrent membership in a weight management program.
  • Inability or unwillingness of parent to accompany the child to nutrition classes.
  • Pregnancy

结局指标

主要结局

weight

时间窗: 6 months and 1 year

body mass index

时间窗: 6 months and 1 year

% body fat

时间窗: 6 months and 1 year

lipids

时间窗: 6 months and 1 year

blood pressure

时间窗: 6 months and 1 year

glucose

时间窗: 6 months and 1 year

insulin

时间窗: 6 months and 1 year

HOMA index

时间窗: 6 months and 1 year

次要结局

  • planned to compare dieting with non-dieting approach in weight management group(6 months and 1 year)

研究者

申办方类型
Other

研究点 (2)

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