Clinical trial NCT05977218: DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial
Official title: DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diet
Mobile health
HbA1c
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2023-08-04
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Unhealthy diet is a major target in the prevention and treatment of type 2 diabetes (T2D) but access to dieticians in primary care is limited. While mobile health (mHealth) tools have been shown to improve diet and clinical management of patients with T2D, there are currently no such mHealth tools for patients with T2D in Sweden. The key limitation of existing mHealth tools is that they provide generic dietary advice that is often difficult to implement in practice (e.g., non-specific suggestions to choose low-sugar products). The George Institute for Global Health (Sydney, Australia) as developed the FoodSwitch mobile phone application (app), which suggests healthier food choices to consumers after scanning of packaged food items in the grocery store. In the DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients trial (DIATEST-HELP), we will adapt the FoodSwitch app for use in Sweden, and study the effect on glycated haemoglobin (HbA1c), blood lipids, and low-grade inflammation in individuals with T2D using a randomized controlled trial design.

Detailed description: Unhealthy diet is a major target in the prevention and treatment of type 2 diabetes (T2D) but access to dieticians in primary care is limited. While mobile health (mHealth) tools have been shown to improve diet and clinical management of patients with T2D, there are currently no such mHealth tools for patients with T2D in Sweden. The key limitation of existing mHealth tools is that they provide generic dietary advice that is often difficult to implement in practice (e.g., non-specific suggestions to choose low-sugar products). The George Institute for Global Health (Sydney, Australia) as developed the FoodSwitch mobile phone application (app), which suggests healthier food choices to consumers after scanning of packaged food items in the grocery store. In the DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients trial (DIATEST-HELP), we will adapt the FoodSwitch app for use in Sweden, and study the effect on glycated haemoglobin (HbA1c), blood lipids, and low-grade inflammation in individuals with T2D using a randomized controlled trial design.

Eligibility criteria: Inclusion criteria:

* Age 18-75 years
* Self-reported diabetes type 2, with or without medication
* Regularly participate in grocery shopping

Exclusion criteria:

* No access to BankID (a digital identification system commonly used in Sweden), thus unable to consent to the study
* Fail to complete the run-in procedures.

Primary outcomes:
measure: HbA1c (mmol/mol)
timeFrame: Change from baseline at week 26
Secondary outcomes:
measure: Total cholesterol (mmol/l)
timeFrame: Change from baseline at week 26
measure: LDL (mmol/l)
timeFrame: Change from baseline at week 26
measure: HDL (mmol/l)
timeFrame: Change from baseline at week 26
measure: Proteomics, and metabolomics
timeFrame: Change from baseline at week 26
measure: Self-measured waist circumference (cm)
timeFrame: Change from baseline at week 26
measure: Self-reported quality of life
timeFrame: Change from baseline at week 26
measure: Self-measured body weight (kg)
timeFrame: Change from baseline at week 26
Other outcomes:
Locations:
Study officials:
affiliation: Linkoeping University
name: Karin Rådholm, MD, PhD
role: STUDY_DIRECTOR
References: