Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 296
- 试验地点
- 2
- 主要终点
- Child Body Mass Index Z-score (BMIz) at Baseline and Month 8
研究概览
简要总结
The purpose of this study is to learn if providing a family-based group program using mobile health technology (iAmHealthy Healthy Lifestyles Program) is effective at improving child weight, nutrition, and physical activity.
详细描述
This is a cluster-randomized study that will test the iAmHealthy Healthy Lifestyles Program versus a standard approach to weight loss in kids current in 2nd thru 4th grade. The iAmHealthy Healthy Lifestyles Program utilizes mobile tools to deliver the weight loss program to kids and families in rural settings. This study will include kids from schools in rural cities/counties, and their parents, and they will be randomly assigned to a group by their school.
The iAmHealthy Healthy Lifestyles Program is a rurally tailored telemedicine intervention. It delivers behavioral, nutritional, and physical activity topics for kids and their families. The total length of the intervention will be about 8 months, which coincides with the length of a typical school year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Family lives in a rural area (city and/or county population less than 20,000)
- •Child Body Mass Index (BMI) >85th and <99th percentile
- •Child in 2nd thru 4th grade
- •Child and Parent speak English
- •Family is available at times intervention is offered
排除标准
- •Child has physical limitation or receives an injury which significantly limits physical mobility
- •Child has significant medical issue
- •Child and Parents have significant developmental delay or cognitive impairment
- •Child has a sibling who has already enrolled in the program
- •Family moves to a non-participating school
结局指标
主要结局
Child Body Mass Index Z-score (BMIz) at Baseline and Month 8
时间窗: Baseline to Month 8
Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = \[(BMI/M)\^L - 1\] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.
次要结局
- Child Body Mass Index Z-score (BMIz) at Baseline and Month 20(Baseline to Month 20)
- Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages(Baseline, Month 8, Month 20)
- Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of "Red Foods" (Foods High in Sugar and/or Fat)(Baseline, Month 8, Month 20)
- Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day(Baseline, Month 8, Month 20)
- Physical Activity - % Time in Sedentary Activity(Baseline, Month 8, Month 20)
- Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables(Baseline, Month 8, Month 20)
- Parent Body Mass Index (BMI)(Baseline, Month 8, Month 20)