Improvement of Fitness and Health in Children With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Program attendance by the child and parent in the exercise class arm
研究概览
简要总结
This study observes fitness level and health parameters in children ages 6-12 years old with obesity using an exercise class intervention.
详细描述
The purpose of this study is to improve physical fitness and health parameters in elementary-aged children who participate in an academic weight loss clinic. Patients and their parents are randomly assigned to either take exercise classes or to continue standard care (control group). Exercise classes are run at a local church 3 times a week for 8 weeks and children and parents are expected to participate. Parents are expected to follow similar dietary and exercise recommendations which are given to their children. Vitals, lab work and fitness testing are done on children at beginning, middle and end of the 6- month study. Vitals are done on parents at the beginning, middle and end of the study. Children are given Fitbits to record sleep patterns and daily physical activity.
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
- 是
入选标准
- •Child must be a patient at the Penn State Hershey Children's Hospital Pediatric Multidisciplinary Weight Loss Program
- •Child must be ages 6-12 years old
排除标准
- •Lack of transportation to exercise classes
- •Parents do not agree to participate in the exercise classes
研究组 & 干预措施
Exercise classes
This group of children and their parents will participate in an exercise class for 8 weeks.
干预措施: Exercise class (Other)
Home exercise
This group of children and their parents will participate in exercise at home for 8 weeks. This is currently the standard of care in the weight management clinic (advise to continue increasing activity at home). This group is considered the "control group."
干预措施: Home exercise (Other)
结局指标
主要结局
Program attendance by the child and parent in the exercise class arm
时间窗: 8 weeks
Class attendance will be taken at each class that is held 3x/week for 8 weeks
Change in amount of Fitness in Obese Children as measured by daily physical activity via Fitbit
时间窗: 8 weeks and 6 months
measurement of amount of daily physical activity (in minutes) hours) as measured by daily physical activity via Fitbit
Change in intensity of daily activity in obese children
时间窗: 8 weeks and 6 months
measurement of intensity of daily activity measured by minutes of elevated heart rate via Fitbit
Change in sleep in obese children
时间窗: 8 weeks and 6 months
measurement of amount of sleep measured in hours via Fitbit
次要结局
- Amount of sleep in children(daily for 6 months)
- Parental vital signs: heart rate(8 weeks and 6 months)
- Metabolic parameters of children with obesity: Cholesterol (Lipid Panel)(8 weeks and 6 months)
- Metabolic parameters of children with obesity: Hemoglobin A1c levels(8 weeks and 6 months)
- Metabolic parameters of children with obesity: Liver Function Tests (LFTs)(8 weeks and 6 months)
- Depression measurements in children with obesity(8 weeks and 6 months)
- Parental vital signs: Body Mass Index (BMI)(8 weeks and 6 months)
- Metabolic parameters of children with obesity: Body Mass Index (BMI)(8 weeks and 6 months)
- Metabolic parameters of children with obesity: Blood glucose (sugar)(8 weeks and 6 months)
- Metabolic parameters of children with obesity: Insulin level(8 weeks and 6 months)
- Metabolic parameters of children with obesity: blood pressure(8 week and 6 months)
- Metabolic parameters of children with obesity: resting heart rate(8 weeks and 6 months)
- Parental vital signs: blood pressure(8 weeks and 6 months)
- Motivation of children with obesity and their parents(8 weeks and 6 months)
- Fitness Testing of children with obesity(8 weeks and 6 months)
研究者
Marsha Novick
Associate Professor
Milton S. Hershey Medical Center