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临床试验/NCT02507791
NCT02507791已完成不适用

Impact of Fitbit Plus Weight Management Program on Physical Activity and Metabolic Disease in Obese Adolescents

University Hospitals Cleveland Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
BMI z-score

研究概览

简要总结

This study is evaluating the feasibility and efficacy of using Fitbit Charge HR devices to remotely track the physical activity of obese pediatric patients who are concurrently enrolled in a comprehensive weight loss intervention program. Patients will receive Fitbit devices and will be called weekly to review their average daily steps and heart rates. Patients will receive the Fitbit either at the beginning of classes or upon completion of classes. Patients will then be followed remotely and called weekly for 12 additional weeks after completing classes. The two groups will be compared to examine for differences.

详细描述

Patients will be randomly assigned into one of two groups. In the first group, patients will undergo an already established multidisciplinary weight loss intervention program and will also wear Fitbit Charge HR devices. Their data will be regularly uploaded to their Fitbit Dashboard, and this information will be reviewed by the study team.

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
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Enrollment in the Healthy Kids, Healthy Weight assessment and intervention program
  • •BMI greater than or equal to the 95th percentile

排除标准

  • •Compromising medical condition that prevents physical activity (sickle cell disease, severe asthma, fractures, etc)
  • •Severe intellectual disability
  • •History of smoking
  • •Current use of atypical antipsychotics, stimulants

研究组 & 干预措施

Early Fitbit

Experimental

Patients will receive Fitbit in the first phase of the study. In addition to attending weekly weight management classes, patients will wear Fitbit Charge HR devices to track heart rate, "active minutes," steps taken, calories burned, and sleep patterns. Patients will receive weekly phone calls to review this data, and further recommendations will be given to encourage additional physical activity as clinically indicated based on time spent being physically active. The goal will be for individuals to reach 10,000 steps per day, though if subjects are significantly under that goal, realistic goal-setting (recommended increases of physical activity of 10% at a time). Patients will continue this intervention for 12 weeks. After 12 weeks, they will return for reassessment. This coincides with the completion of the weight loss program. Subjects will then be followed remotely for another 12 weeks and phone call interventions will continue before returning for a final study visit.

干预措施: Fitbit Charge HR plus weekly phone calls to review physical activity data (Other)

Late/Delayed Fitbit

Active Comparator

These subjects will follow a similar pattern except they will not receive Fitbit Charge HR devices until the second phase of the study (specifically after completion of the 12 week weight loss program). In the first phase, these subjects will receive weekly phone calls to offer them the same attention as the experimental group, but instead of reviewing Fitbit data, these subjects will subjectively report their physical activity in minutes and by qualifying their physical activity as light, moderate, or vigorous. These individuals, after 12 weeks, will return for reassessment. At that time, these individuals will receive Fitbits and receive weekly telephone calls for an additional 12 weeks before returning for a final study visit.

干预措施: Fitbit Charge HR plus weekly phone calls to review physical activity data (Other)

结局指标

主要结局

BMI z-score

时间窗: 12 weeks

physical activity as measured by Actigraph

时间窗: 12 weeks

次要结局

  • fasting lipid panel(12 weeks)
  • Estimation of VO2 max(12 weeks)
  • Responses to self-image questionnaire (SIQYA)(12 weeks)
  • Body composition measured by bioelectrial impedance analysis(12 weeks)
  • Minutes per day in moderate/vigorous physical heart rate range(Daily for 24 weeks)
  • fasting glucose(12 weeks)
  • Hemoglobin A1c(12 weeks)
  • Resting energy expenditure(12 weeks)
  • Average steps taken per day(Daily for 24 weeks)
  • fasting insulin(12 weeks)
  • Blood pressure(12 weeks)
  • Responses to sleep questionnaire(12 weeks)
  • Resting heart rate(Daily for 24 weeks)
  • Active minutes(Daily for 24 weeks)
  • Physical activity self-efficiacy questionnaire(12 weeks)

研究者

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

Ryan Farrell

Fellow

University Hospitals Cleveland Medical Center

研究点 (1)

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