Bikes For Life: Measuring the Effects of a Bicycle Distribution Program on Pediatric Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 525
- 主要终点
- Change in Body Mass Index
研究概览
简要总结
The investigators propose a study to evaluate the success of a bicycle distribution program in increasing physical activity level, decreasing sedentary activity levels and positively affecting body-mass index (BMI) in participants aged 6 to 12 years old with overweight or obesity, who do not already own a bicycle, and are patients at the Children's Hospital Colorado Child Health Clinic (CHC), Lifestyle Medicine Clinic, or Rocky Mountain Youth Clinics. The investigators anticipate that the receipt of a bicycle will increase physical activity level, decrease sedentary activity time and decrease or stabilize patients' BMI. The investigators will answer this research question by distributing bicycles to 525 children and conducting follow up visits over the course of a year to measure the outcomes of interest.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 6-12 years
- •Do not own a bicycle
- •BMI over 85% for age (overweight or obese)
排除标准
- •Outside of state age range
- •Not overweight or obese
- •Already own a bicycle.
结局指标
主要结局
Change in Body Mass Index
时间窗: Change from Baseline BMI through study completion up to 78 weeks
Change in Physical Activity
时间窗: Change from Baseline Physical Activity through study completion up to 78 weeks
Average time spent participating in physical activity
Change in Sedentary Activity
时间窗: Change from Baseline Sedentary Activity through study completion up to 78 weeks
Average time spent in sedentary activities
次要结局
- Change in Consumption of sugary drinks(Change from Baseline Consumption of Sugary Drinks through study completion up to 78 weeks)
- Change in Consumption of Fast Food(Change from Baseline Consumption of Fast Food through study completion up to 78 weeks)
- Change in Consumption of Fruits(Change from Baseline Consumption of Fruits through study completion up to 78 weeks)
- Change in Consumption of Vegetables(Change from Baseline Consumption of Vegetables through study completion up to 78 weeks)