Prevention and Development of Lifestyle Diseases With the Health and Lifestyle Tool
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Region Skane
- 入组人数
- 77,000
- 试验地点
- 2
- 主要终点
- Incidence of type 2 diabetes
研究概览
简要总结
In this study participants will be randomized to use a digital lifestyle tool over three years or to a control group without access to the tool. The investigators will prospectively via clinical registries follow the incidence and development of type 2 diabetes over three years in those using the tool regularly and those in the control group.
详细描述
Considerable evidence suggest that lifestyle changes can prevent or delay the onset of type 2 diabetes, and self-care behaviors largely determine HbA1c. Modifiable lifestyle factors have been established as key drivers of disease onset, progression, and prognosis, motivating the use of "lifestyle as medicine".
Digital health tools are increasingly incorporated into diabetes care, and have the potential to improve both behavioral and clinical outcomes on a broad basis. However, low levels of uptake, reduced user engagement over time, and low acceptance among patients, raise concerns about their effectiveness.
The objective or this study is to evaluate a new web-based tool, developed at the University Gothenburg, Sweden, that aims to support patient autonomy and motivation to make sustainable lifestyle changes.
The investigators will test the hypothesis that individuals who have access to the tool get lower incidence of type 2 diabetes or in case they already have diabetes develop improved glucose control compared with control individuals. The participants will complete the Findrisc questionnaire to assess the risk for type 2 diabetes to enable analysis of individuals with different risk.
The study is an investigator-initiated single-center study conducted over three years.
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
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent
- •Age above 35 years
排除标准
- •type 1 diabetes, MODY or secondary diabetes
- •conditions or treatments that in the judgement of the Investigator could affect the study evaluation
- •connection with the study team, funders, authorities, universities or other public or private bodies in such a way that specific interests in the study outcomes could be suspected.
结局指标
主要结局
Incidence of type 2 diabetes
时间窗: 3 years
Incidence of type 2 diabetes defined as random plasma glucose \>11.1 mmol/L or fasting glucose \>7.0 mmol/L or HbA1C ≥6.5% compared between participants regularly using the tool and on usual care.
Change of long-term blood glucose concentration measured as glycated hemoglobin at end of follow-up
时间窗: 3 years
Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at end of follow-up relative to baseline compared between participants regularly using the tool and on usual care.
Prescription of anxiolytic medication
时间窗: 3 years
Number of participants on prescription of anxiolytic medication between participants regularly using the tool and on usual care.
Prescription of antidepessive medication
时间窗: 3 years
Number of participants on prescription of antidepressive medication between participants regularly using the tool and on usual care.
次要结局
- Change of Anxiety estimated by General Anxiety Disorder 7-item scale(1 year)
- Change of Patient Health Questionnaire 9-item scale(1 year)