DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Linkoeping University
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- Mean HbA1c
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Lana Hebib
Principal investigator
Linkoeping University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mean HbA1c
Time Frame: Change from baseline at week 26
Mean glycated haemoglobin
Secondary Outcomes
- 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)