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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Access to the 'DiabetesSwitch' filter of the FoodSwitch app when grocery shopping during 26 weeks, in addition to standard written dietary advice |
|
| Control | No Intervention | Access to standard written dietary advice |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FoodSwitch | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean HbA1c | Mean glycated haemoglobin | Change from baseline at week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-measured waist circumference (cm) | Self-measured waist circumference (cm) | Change from baseline at week 26 |
| Self-reported quality of life | Self-reported quality of life - questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary effects on proteomics and metabolomics | Dietary effects on proteomics and metabolomics | Change from baseline at week 26 |
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lana Hebib, MD | Contact | 013-28 10 00 | lana.hebib@liu.se |
| Name | Affiliation | Role |
|---|---|---|
| Karin Rådholm, MD, PhD | Linkoeping University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linköping University | Recruiting | Linköping | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41248424 | Derived | Af Geijerstam P, Johansson E, Fagerstam S, Wu JH, Ghafouri B, Karlsson K, Hebib L, Kastbom L, Wennberg P, Gustafson Hedov E, Storgards M, Sundstrom J, Radholm K. Effect of the FoodSwitch application on type 2 diabetes in Sweden: a study protocol for the randomised controlled DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients trial (DIATEST-HELP). BMJ Open. 2025 Nov 16;15(11):e110141. doi: 10.1136/bmjopen-2025-110141. |
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After publication in a peer-reviewed journal and for the period of time for which local archive regulations stipulate.
To be determined on a case by case basis.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Change from baseline at week 26 |
| Self-measured body weight (kg) | Self-measured body weight (kg) | Change from baseline at week 26 |
| Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications | Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications | Change from baseline at week 26 |
| Self-reported dietary self-efficacy | Self-reported dietary self-efficacy | Change from baseline at week 26 |
| Difference in all-cause mortality | Difference in all-cause mortality | Change from baseline at week 26 |
| D004700 | Endocrine System Diseases |