A Pilot Cluster Randomized Controlled Trial of a Digital Lifestyle Intervention for Individuals With Prediabetes or Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in the scores on the Summary of Diabetes Self-Care Activities - Revised (SDSCA)
研究概览
简要总结
The study aims to evaluate the acceptability, feasibility, and preliminary efficacy of a digital lifestyle intervention, called Fitness Digital (FitD), for individuals with prediabetes or type 2 diabetes.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong resident
- •Can understand Chinese and Cantonese
- •Have self-reported diagnosis of type 2 diabetes or prediabetes
- •Have a smart phone and able to use a mobile app
排除标准
- 未提供
结局指标
主要结局
Changes in the scores on the Summary of Diabetes Self-Care Activities - Revised (SDSCA)
时间窗: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
The Summary of Diabetes Self-Care Activities consists of 11 items asking the frequency of diabetes self-care behavior in the following six areas: general diet, specific diet (ate fruit and vegetable/ low fat diet), exercise, blood glucose testing, foot care, and cigarette smoking. The maximum score is 70 and the minimum score is 0. A higher total score indicate better self-care.
Changes in weight from baseline (week 0) to posttreatment (week 9)
时间窗: Baseline (week 0), posttreatment (week 9), follow-up (week 21)
Self-reported weight in kilograms
次要结局
- Changes in the scores on the Weight Control Strategy Scale(Baseline (week 0), posttreatment (week 9), follow-up (week 21))
- Changes in the scores on the Physical activity acceptance and action questionnaire(Baseline (week 0), posttreatment (week 9), follow-up (week 21))
- Changes in the scores on the Weight loss self-efficacy scale(Baseline (week 0), posttreatment (week 9), follow-up (week 21))
研究者
Dr. Chan Wai Sze
Assistant Professor
The University of Hong Kong