DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Mean HbA1c
研究概览
简要总结
This randomized controlled trial will assess the impact of the FoodSwitch mobile app, which provides interpretive front-of-pack labelling via barcode scanning, in 900 Swedish adults with type 2 diabetes. Participants will be randomized to app + standard advice or standard advice alone. The primary outcome is change in HbA1c at 6 months; secondary outcomes include anthropometrics, quality of life, medication use, hospitalizations, and mortality.
详细描述
A healthy diet improves glycaemic control and reduces cardiovascular risk in type 2 diabetes (T2D), but access to dietitians is limited. Unlike several countries, Sweden has not implemented interpretive front-of-pack labelling. Smartphone applications may offer an alternative. This trial evaluates the dietary and clinical impact of FoodSwitch, a mobile app providing interpretive labelling to Swedish adults with T2D. Nine hundred individuals with T2D for ≥2 years who regularly shop for groceries will be recruited via general practices and community advertisements and randomized to receive access to FoodSwitch plus standard written dietary advice, or standard written dietary advice only. The primary outcome is change in self-measured glycated haemoglobin (HbA1c) after 6 months. Secondary outcomes include waist circumference, body weight, quality of life, dietary self-efficacy, medication use, hospitalizations, and all-cause mortality. Exploratory outcomes include omics analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Self-reported type 2 diabetes with a duration of ≥2 years
- •Regularly grocery shopping
排除标准
- •No access to BankID (a digital identification system commonly used in Sweden)
- •Failure to complete eligibility screening and run-in periods
结局指标
主要结局
Mean HbA1c
时间窗: Change from baseline at week 26
Mean glycated haemoglobin
次要结局
- Self-measured body weight (kg)(Change from baseline at week 26)
- Self-measured body weight (kg)(Change from baseline at week 26)
- Self-reported dietary self-efficacy(Change from baseline at week 26)
- Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications(Change from baseline at week 26)
- Difference in all-cause mortality(Change from baseline at week 26)
- Self-measured waist circumference (cm)(Change from baseline at week 26)
- Self-reported quality of life(Change from baseline at week 26)
研究者
Lana Hebib
Principal investigator
Linkoeping University