Impact of Fitbit Plus Weight Management Program on Physical Activity and Metabolic Disease in Obese Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 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
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
Ryan Farrell
Fellow
University Hospitals Cleveland Medical Center