MedPath

DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial

Not Applicable
Not yet recruiting
Conditions
Type 2 Diabetes
Interventions
Other: FoodSwitch
Registration Number
NCT05977218
Lead Sponsor
Linkoeping University
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
900
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionFoodSwitchAccess to the 'DiabetesSwitch' filter of the FoodSwitch app when food shopping during 26 weeks.
Primary Outcome Measures
NameTimeMethod
HbA1c (mmol/mol)Change from baseline at week 26

Hemoglobin A1C (mmol/mol)

Secondary Outcome Measures
NameTimeMethod
Total cholesterol (mmol/l)Change from baseline at week 26

Total cholesterol (mmol/l)

LDL (mmol/l)Change from baseline at week 26

Low-density lipoprotein (mmol/l)

HDL (mmol/l)Change from baseline at week 26

High-density lipoprotein (mmol/l)

Proteomics, and metabolomicsChange from baseline at week 26

The analysis of proteomics and metabolomics is explorative, and therefore the selection of proteins and metabolites is not pre-determined but will rather include those that are available and deemed appropriate at the time of analysis

Self-measured waist circumference (cm)Change from baseline at week 26

Self-measured waist circumference (cm)

Self-reported quality of lifeChange 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)

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