The HAPPY-study: Digital Support for Healthier Eating Habits in Patients with Diabetes Type 2 - a Randomized Clinical Trial Within Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Change in dietary intake
研究概览
简要总结
The aim of this study is to investigate the effect of using new app-based technology to improve dietary habits, compared to usual care in patients with type 2 diabetes. The hypothesis is that the intervention, i.e. using the new technology an an app-based course for healthy eating habits, will have a greater positive effect on dietary habits and biological markers, including HbA1c and serum lipids, than usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Have a diagnosis of type 2 diabetes
- •18 years of age or older
- •Ability to communicate in Swedish
- •Own and use a smartphone with a personal digital ID
排除标准
- •No specific exclusion criteria apply
研究组 & 干预措施
App-technology group
Participants in the App-technology group arm will use a newly developed smartphone application ("app"), containing a 12-week healthy eating program.
Intervention: App-technology for healthy eating habits.
干预措施: App-technology for healthy eating habits (Behavioral)
Control group
The control group will receive standard care.
结局指标
主要结局
Change in dietary intake
时间窗: Baseline and month 3, and 6
Change in dietary intake assessed using a four day food record.
次要结局
- HbA1c(Baseline and month 3, and 6)
- HDL-cholesterol(Baseline and month 3, and 6)
- Total cholesterol(Baseline and month 3, and 6)
- Body Mass Index (BMI)(Baseline and month 3, and 6)
- Body weight(Baseline and month 3, and 6)
- Body composition: Body fat(Baseline and month 3, and 6)
- Waist circumference(Baseline and month 3, and 6)
- Triglycerides(Baseline and month 3, and 6)
- Body composition: Fat free mass(Baseline and month 3, and 6)
- Body composition: Muscle mass(Baseline and month 3, and 6)
- Body composition: Total body water(Baseline and month 3, and 6)
- Blood pressure(Baseline and month 3, and 6)
研究者
Stephanie Bonn
PhD, Assistant professor
Karolinska Institutet