DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLinkoeping University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years
Self-reported type 2 diabetes with a duration of ≥2 years
Regularly grocery shopping
Disqualifiers
No access to BankID (a digital identification system commonly used in Sweden)
Failure to complete eligibility screening and run-in periods
Trial design
Design model
Parallel
Treatments tested in this trial
FoodSwitch
Other interventionAccess 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.
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Mean HbA1c
Mean glycated haemoglobin
Time frame
Change from baseline at week 26Secondary outcomes
1
Self-measured waist circumference (cm)
Self-measured waist circumference (cm)
Time frame
Change from baseline at week 262
Self-reported quality of life
Self-reported quality of life - questionnaire
Time frame
Change from baseline at week 263
Self-measured body weight (kg)
Self-measured body weight (kg)
Time frame
Change from baseline at week 264
Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications
Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications
Time frame
Change from baseline at week 26Other outcomes
1
Dietary effects on proteomics and metabolomics
Dietary effects on proteomics and metabolomics
Time frame
Change from baseline at week 26Sponsors and contacts
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Source ClinicalTrials.gov