DIgitAl diabeTES Treatment - the Healthy Eating, heaLthy Patients Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое FoodSwitch
  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.

Первичные конечные точки

• Mean HbA1c [Срок оценки: Change from baseline at week 26]

Вторичные конечные точки (6)

• Self-measured waist circumference (cm) [Срок оценки: Change from baseline at week 26]
• Self-reported quality of life [Срок оценки: Change from baseline at week 26]
• Self-measured body weight (kg) [Срок оценки: Change from baseline at week 26]
• Registry-based data on medication use, hospitalizations, outpatient visits, and diabetes complications [Срок оценки: Change from baseline at week 26]
• Self-reported dietary self-efficacy [Срок оценки: Change from baseline at week 26]
• Difference in all-cause mortality [Срок оценки: Change from baseline at week 26]

Критерии участия

Критерии включения

• Age between 18 and 75 years
• Self-reported type 2 diabetes with a duration of ≥2 years
• Regularly grocery shopping

Критерии исключения

• No access to BankID (a digital identification system commonly used in Sweden)
• Failure to complete eligibility screening and run-in periods

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Швеция · 1 центр

• Linköping University — Linköping

Публикации

• 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 PMID 41248424

Идентификаторы

NCT: NCT05977218 · DIATEST-HELP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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