NCT05662826暂停不适用
A Virtual Home Intervention to Promote Physical Activity Among Youth With Type 1 Diabetes Part 2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Engagement
研究概览
简要总结
This study is testing program where teens with type 1 diabetes play Meta Quest 2 virtual reality exercise games and talk, act, and paint about physical activity in virtual meetings with their peers and young adult role models. The outcomes are feasibility and user satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 14-17 years
- •Diagnosis of type 1 diabetes or other absolute insulin deficiency diabetes for ≥6 months
- •Moderate-to-vigorous physical activity less than half of recommended levels (defined as ≤3 days per week achieving ≥60min daily MVPA)
- •English literacy
- •Home Broadband wireless Internet (≥25 mbps downloads, ≥3 mbps uploads on google Internet speed test). This is used in ~98% of US households.
- •Willing to use continuous glucose monitor for the duration of participation in the trial.
- •Willing to use a computer or smartphone with web camera.
- •Under regular care by a healthcare provider (defined as attending at least one appointment in the past year, plus access to verified 24hr phone number to reach the provider's team for insulin dose adjustments if assistance is needed)
排除标准
- •A condition or disability besides type 1 diabetes that would preclude participation in group moderate-to-vigorous physical activity (e.g., cerebral palsy, current pregnancy)
结局指标
主要结局
Engagement
时间窗: 4 weeks
Number of classes attended
Satisfaction
时间窗: 4 weeks
Score on a satisfaction survey that has been custom-designed for the components of this program. Scores range from 0 to 4. A higher score indicates greater satisfaction with the program.
次要结局
- Motivation for exergame play(4 weeks)
- Multimodal presence(4 weeks)
- Perceived cohesion(4 weeks)
- System usability(4 weeks)
研究者
研究点 (2)
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