EMPower: Electronic Media Powering Positive Health Changes in Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Change in adiposity as measured by change in BMI z-score
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a technology-based behavioral Healthy Lifestyle intervention on adiposity (body mass index z-score), blood pressure (mean clinic systolic BP), and heart size (LVM) in comparison to standard care.
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
- 13 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight or Obese
- •Speaks English
排除标准
- •No smart phone / smart phone data plan
- •Not willing to send/ receive text messages or download and use the study applications
- •Neurological impairment/ developmental delay
- •New / changes in anti-hypertensive medication or medication known to affect blood pressure within the last 6 months
- •Prior diagnosis of congenital heart disease or cancer
- •Pregnancy
- •Taking medication with weight gain as a side effect
- •Taking medications for weight loss/ participation in another weight loss program
研究组 & 干预措施
Electronic Media Application
Participants will receive an age-appropriate behavioral intervention designed to promote weight loss, improved diet quality, and exercise.
干预措施: Electronic Media Application (Behavioral)
Control
Participants will receive standard of care education and feedback on how to implement a heart healthy lifestyle to promote weight loss, improved diet quality and exercise.
干预措施: Standard of care education (Behavioral)
结局指标
主要结局
Change in adiposity as measured by change in BMI z-score
时间窗: 6 months from date of randomization
次要结局
- Change in clinic systolic blood pressure(6 months from date of randomization)
- Change in left ventricular mass index(6 months from date of randomization)