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临床试验/NCT04312919
NCT04312919已完成不适用

Cleveland Clinic Families Get Fit (CCFit) : A Family-based Activity-Monitor Intervention in Pediatric Obesity

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2020年2月3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
63
试验地点
2
主要终点
Exercise Capacity

研究概览

简要总结

This is a randomized prospective study to evaluate the effectiveness of a family-based intervention using activity-monitors (I.e. Fitbits) in children and adolescents aged 8-18 years with a BMI greater than or equal to 95%ile who attend the Cleveland Clinic multidisciplinary "Be Well" pediatric obesity clinic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Be Well patient
  • Age 8*-18 years
  • BMI > 95%ile
  • English speaking

排除标准

  • Uncontrolled asthma
  • Orthopedic or other medical issue limiting mobility
  • Participant has worn an activity-monitor in the past 6 months (ok if parents wear)

结局指标

主要结局

Exercise Capacity

时间窗: Change from Baseline Six Minute Walk Distance through study completion (up to 33 weeks)

6 minute walk distance

次要结局

  • Fitbit Data(Change in steps per day wearing Fitbit and after 1 week Goal Setting Steps)
  • Height(Change from Baseline height through study completion (up to 33 weeks))
  • Weight(Change from Baseline weight through study completion (up to 33 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Mucci

Associate Staff Physician

The Cleveland Clinic

研究点 (2)

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