NCT06018844终止不适用
Novel mHealth Physical Activity Intervention for Youth With Type 1 Diabetes Mellitus
Children's Mercy Hospital Kansas City1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2024年7月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- %Daily Text Messages Exchanged Between Youth and the NUDGE Bot
研究概览
简要总结
The goal of this longitudinal cohort study is to learn about a mHealth intervention in Type 1 Diabetes (T1D)
The main question[s] it aims to answer are:
- Does the intervention increase the amount of text messages between the mHealth software and participants?
- Do the text messages from the Nudge software increase moderate to vigorous physical activity (MVPA) in participants?
- Does the MVPA encouraged by the Nudge software improve the HbA1c levels of participants?
Participants will:
- Receive text messages from the Nudge software
- Report physical activity goals via the text messages to the Nudge software
- Wear both an accelerometer and an actigraph for three weeks (spread out across the beginning, 30 days, and 90 days of participation)
- Complete surveys at the beginning of participation
- Complete daily surveys while wearing the devices
- Complete surveys at the end of participation
- Record physical activity in study surveys
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants 12.00-21.99 years old
- •Participants with a physician confirmed T1D diagnosis.
- •T1D diagnosis was at least 6 months prior to study enrollment
- •Participants are on an intensive insulin regiment (either with an insulin pump or multiple daily injection)
- •Participants must be using a continuous glucose monitor (CGM)
- •Participants and parents/legally authorized representatives (LARS) of participants less than 18.00 speak/read English.
排除标准
- •Participants with evidence of type 2 or monogenic diabetes.
- •Participants with a comorbid chronic condition (e.g., renal disease).
- •Participants with presence of severe psychiatric disorders.
- •Participants with a diagnosis of low vision (vision that cannot be corrected with contact lenses or eyeglasses).
- •Participants with limited mobility that would prevent participant from engaging in daily physical activity, self-assessed by participant.
结局指标
主要结局
%Daily Text Messages Exchanged Between Youth and the NUDGE Bot
时间窗: Through study completion, an average of 3.5 months
percent of daily text messages exchanged between youth and the NUDGE bot
Moderate to Vigorous Physical Activity (MVPA) Levels
时间窗: Day 1, 30 and 90
Participants' MVPA levels
次要结局
- %Daily Physical Activity (PA) Schedules That Participants Complete(Day 1, 30 and 90)
- %Days That Youth Wear the Actigraph(Day 1, 30 and 90)
- Change in Participant HbA1c(Through study completion, an average of 3.5 months)
研究者
研究点 (1)
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