Type 2 Diabetes
Conditions
Keywords
Diet, Mobile health, HbA1c
Brief summary
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.
Detailed description
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.
Interventions
OTHERFoodSwitch
Access to the 'DiabetesSwitch' filter of the FoodSwitch app when grocery shopping. When a packaged food item bar code is scanned, the FoodSwitch app will show an interpretive nutritional information score for the scanned product and recommend alternate healthier food options in the same category.
Sponsors
Linkoeping University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 years * Self-reported type 2 diabetes with a duration of ≥2 years * Regularly grocery shopping
Exclusion criteria
* No access to BankID (a digital identification system commonly used in Sweden) * Failure to complete eligibility screening and run-in periods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean HbA1c | Change from baseline at week 26 | Mean glycated haemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-measured waist circumference (cm) | Change from baseline at week 26 | Self-measured waist circumference (cm) |
| Self-reported quality of life | Change from baseline at week 26 | Self-reported quality of life - questionnaire |
| Self-measured body weight (kg) | Change from baseline at week 26 | Self-measured body weight (kg) |
| Self-reported dietary self-efficacy | Change from baseline at week 26 | Self-reported dietary self-efficacy |
| Difference in all-cause mortality | Change from baseline at week 26 | Difference in all-cause mortality |
| Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications | Change from baseline at week 26 | Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dietary effects on proteomics and metabolomics | Change from baseline at week 26 | Dietary effects on proteomics and metabolomics |
Countries
Sweden
Contacts
Primary ContactLana Hebib, MD
Outcome results
None listed