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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Sep 20, 2025
Date Accepted: Feb 17, 2026

The final, peer-reviewed published version of this preprint can be found here:

Effect of a Personalized Mobile Health Intervention Using Artificial Intelligence (the WARIFA App) Versus a Nonpersonalized Intervention on User-Defined Objectives, Healthy Lifestyles, and Management of Type 1 Diabetes (T1D): Protocol for a Randomized Controlled Trial

Betancort Acosta C, Zamora Zamorano G, Álvarez Malé ML, Perestelo-Perez L, Torres Castaño A, Veierød MB, Reyes Suárez K, Déniz García A, Årsand E, Torhild Gram I, Løchen ML, Soguero-Ruiz C, Henriksen A, Rodríguez Almeida AJ, Muzny M, Välimäki R, Schopf T, Fabelo Gomez H, Granja C, Wägner AM

Effect of a Personalized Mobile Health Intervention Using Artificial Intelligence (the WARIFA App) Versus a Nonpersonalized Intervention on User-Defined Objectives, Healthy Lifestyles, and Management of Type 1 Diabetes (T1D): Protocol for a Randomized Controlled Trial

JMIR Res Protoc 2026;15:e84510

DOI: 10.2196/84510

PMID: 42172625

Effect of a personalised mobile health intervention using artificial intelligence (the WARIFA app) versus a non-personalised intervention on user-defined objectives, healthy lifestyles and management of type 1 diabetes (T1D): a randomised controlled trial protocol

  • Carmelo Betancort Acosta; 
  • Garlene Zamora Zamorano; 
  • María Luisa Álvarez Malé; 
  • Lilisbeth Perestelo-Perez; 
  • Alezandra Torres Castaño; 
  • Marit B. Veierød; 
  • Kristina Reyes Suárez; 
  • Alejandro Déniz García; 
  • Eirik Årsand; 
  • Inger Torhild Gram; 
  • Maja-Lisa Løchen; 
  • Cristina Soguero-Ruiz; 
  • André Henriksen; 
  • Antonio J. Rodríguez Almeida; 
  • Miroslav Muzny; 
  • Reetta Välimäki; 
  • Thomas Schopf; 
  • Himar Fabelo Gomez; 
  • Conceição Granja; 
  • Ana M. Wägner

ABSTRACT

Background:

Non-communicable diseases (NCDs) are the leading cause of death and have a high global prevalence. The four main diseases are cardiovascular and respiratory diseases, cancer and diabetes, which share common risk factors and can be prevented through physical activity, a healthy diet, avoiding smoking and alcohol consumption, and other lifestyle changes. Watching the Risk Factors (WARIFA) is a mHealth application (app) created for general health awareness and to support users in adopting healthier behaviours. It also has a functionality to support type 1 diabetes (T1D) management.

Objective:

To evaluate the effectiveness of the WARIFA app with personalised artificial intelligence (AI) driven messages, compared to a non-personalised version, in promoting health-related behaviour change among general population and individuals with T1D.

Methods:

A total of 108 European participants, including individuals with T1D, are randomised (computer-generated sequence, double-blind, 1:1 ratio) to an intervention or control group. In the intervention group, participants use the WARIFA app with personalised messages and the use of AI. This applies to some functionalities, such as personalised recommendations and risk prediction for the four main NCDs. In the control group, participants use a WARIFA app without personalised messages or AI. Both groups are provided with an activity monitor and will use the WARIFA app for 12 weeks. The primary outcome is a self-defined goal, chosen from a set of proposed objectives at baseline and assessed at the end of the study using a Likert scale (0 to 10 points, 0 being no achievement at all and 10 being full achievement of the proposed objective). Secondary outcomes include: engagement with the app, changes in lifestyle behaviour, body composition, lipid profile, glycated haemoglobin (T1D only), hypoglycaemic events (T1D only) and health related quality of life, as well as acquired knowledge, self-efficacy and usability.

Results:

.

Conclusions:

There is evidence that improving lifestyle behaviour can prevent NCDs. In this study, we aim to evaluate the effectiveness of the WARIFA app to improve lifestyle behaviours and T1D management. Clinical Trial: NCT06918444.


 Citation

Please cite as:

Betancort Acosta C, Zamora Zamorano G, Álvarez Malé ML, Perestelo-Perez L, Torres Castaño A, Veierød MB, Reyes Suárez K, Déniz García A, Årsand E, Torhild Gram I, Løchen ML, Soguero-Ruiz C, Henriksen A, Rodríguez Almeida AJ, Muzny M, Välimäki R, Schopf T, Fabelo Gomez H, Granja C, Wägner AM

Effect of a Personalized Mobile Health Intervention Using Artificial Intelligence (the WARIFA App) Versus a Nonpersonalized Intervention on User-Defined Objectives, Healthy Lifestyles, and Management of Type 1 Diabetes (T1D): Protocol for a Randomized Controlled Trial

JMIR Res Protoc 2026;15:e84510

DOI: 10.2196/84510

PMID: 42172625

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