GamerFit: A Digital Intervention to Improve Physical Activity and Sleep Behaviors in Youth With Psychiatric Diagnoses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Feasibility of the App
研究概览
简要总结
The goal of "GamerFit" is to test the delivery of a theory-based mHealth app that utilizes social support, exergaming, and telehealth coaching to improve PA levels, sleep, and psychiatric symptoms among youth participants (ages 13-17 y) with PD. In order to aid future intervention optimization, up to 65 participants with at least one PD will be randomized, with 30-35 using the GamerFit app with weekly telehealth coaching sessions and 30-35 using a commercial healthy habits app as a comparator group
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
- Single (Investigator)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13-17 years of age (child/participant)
- •At least one PD diagnosis (excluding eating disorders) confirmed by parent report of physician diagnosis (child/participant)
- •IQ≥85/no intellectual disability that precludes participation confirmed by parent report (child/participant)
- •Can understand verbal English-language exergaming instructions (child/participant)
- •Physically capable of exercise confirmed by parent report (child/participant)
- •Has access to a smart phone or compatible tablet (child/participant)
- •Willing to download and use the app (child/participant)
- •Willing and able to be present during telehealth coaching sessions (parent)
- •Can have a competent translator present during coaching sessions if not fluent in English (parent)
排除标准
- •Families for whom the mPIs think the study and/or intervention is clinically/medically inappropriate (e.g. developmental delay, or emotional or cognitive difficulties, if the PI believes these factors will interfere with study/intervention participation)
研究组 & 干预措施
GamerFit Condition
Includes use of a Fitbit and exergaming devices, the GamerFit app, and weekly telehealth coaching sessions.
干预措施: GamerFit Condition (Behavioral)
Comparator Condition
Youth assigned to the comparator condition (n=30-35) will receive a Fitbit device (same as the intervention condition) and the Fitbit account activated on their device (e.g. phone/tablet/computer). They will receive instructions on using the PA and sleep tracking features, as well as a booklet of healthy habit tips. They will receive reminders to charge, sync and review their Fitbit data for the duration of the intervention.
干预措施: Comparator Condition (Behavioral)
结局指标
主要结局
Feasibility of the App
时间窗: 12 weeks
Percentage of live coaching sessions attended (i.e. average of the number of coaching sessions attended divided by total number of coaching sessions expected). Because this is a percentage of visits, standard deviations/standard errors are not provided. This data are measured within the group as a whole and not by participants individually.
次要结局
- Physical Activity(12 weeks)
- Sleep(12 weeks)
研究者
Amanda Staiano
Associate Professor
Pennington Biomedical Research Center