Evaluation of the WARIFA App and Its Impact on Healthy Lifestyle

Official title

Effect of the WARIFA App on User-defined Objectives, Healthy Lifestyles and Management of Type 1 Diabetes: a Pilot Randomised Controlled Trial

Overview

The goal of this study is to assess the effect of the WARIFA app on the adoption of healthy lifestyle behaviours related to Non-communicable diseases (NCDs), as well as in the management of Type 1 Diabetes (T1D). This is done using user-generated data analysis, artificial intelligence (AI) and risk estimation to provide personalised recommendations on lifestyle-related behaviours through a mobile app. * Primary objective: the objective of this study is to assess the impact of using the WARIFA app on a series of outcomes, related to the promotion of healthy lifestyles and prevention of NCDs, as well as on the management of T1D. * Secondary objectives: to assess the feasibility of implementation of a complex health app (WARIFA), and to explore which outcomes are more relevant in this context for users. The study will evaluate the app in two different populations: * Population 1: Citizens living in Europe of either sex aged \> 18 years diagnosed with no more than one NCD (of the following: CVD, any type of cancer, chronic respiratory disease and T2D) and current owners of a smartphone with internet access. * Population 2: European adult individuals of either sex aged \>18 years with T1D currently using multiple daily insulin injections or an insulin pump and current owners of a smartphone with internet access. The study will be carried out in three centres in three different countries: the Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) in Spain, the Norwegian Centre for E-health Research (NSE) in Norway, and in Romania. Participants in each population will be randomised to an intervention or control arm on a 1:1 ratio: * Intervention arm: the Warifa app will be used by the participants throughout the study. The app will provide personalised risk estimations and recommendations through user-generated data analysis and artificial intelligence. * Control arm: The control group will use a Warifa app with the same functionalities than the intervention arm, but without artificial intelligence. At baseline, information will be collected by questionnaires and a physical examination, including anthropometry and a lipid profile. These measurements will be repeated in 12 weeks and will be compared between the treatment arms. The study will last 3 months in total, start of recruitment on 10 February 2025, end of study after the last visit of the last participant, on 12 May 2025. Each user will participate in the study for 12 weeks.

Interventions

• Device WARIFA app with AI
  Participants will be given access to the WARIFA app on their mobile phones during the study. This app will collect activity data as well as questionnaires and diaries. Using this data and artificial intelligence, it will provide participants with personalised information and recommendations about their lifestyle and risk of chronic non-communicable diseases.
• Device WARIFA app without AI
  Participants will be given access to the WARIFA app on their cell phones during the study. This app will collect activity data, as well as through questionnaires and diaries. With this data, it will give information and general recommendations to the participants related to their lifestyle habits and risks of chronic non-communicable diseases, following the WHO guidelines. This version will not use artificial intelligence or personalized messages.

Primary outcome measures

• Self-defined goal by the participants [Time frame: At the end of intervention at 12 weeks]

Secondary outcome measures (12)

• Frequency of app use [Time frame: From enrollment to the end of intervention at 12 weeks]
• Time spent using the app [Time frame: From enrollment to the end of intervention at 12 weeks]
• Consistency in data recording [Time frame: From enrollment to the end of intervention at 12 weeks]
• ABACUS scale [Time frame: At the enrollment and the end of intervention at 12 weeks]
• Changes in eating habits [Time frame: From enrollment to the end of intervention at 12 weeks]
• Changes in physical activity [Time frame: From enrollment to the end of intervention at 12 weeks]
• Reduction in tobacco consumption [Time frame: From enrollment to the end of intervention at 12 weeks]
• Reduction in alcohol consumption [Time frame: From enrollment to the end of intervention at 12 weeks]
• Changes in sun protection behaviour [Time frame: At the enrollment and the end of intervention at 12 weeks]
• Changes in sun protection behaviour [Time frame: From enrollment to the end of intervention at 12 weeks]
• Hypoglycaemic events [Time frame: From enrollment to the end of intervention at 12 weeks]
• Hypoglycaemic events [Time frame: From enrollment to the end of intervention at 12 weeks]

Eligibility criteria

Inclusion criteria

• Common for both population groups:
• Adults over 18 years of age.
• Owners of a smartphone operating with Android and with internet access.
• Group 1: General population:
• Healthy or diagnosed with no more than one NCD (CVD, any type of cancer, T2D or chronic respiratory disease).
• Group 2: T1D:
• Treatment with multiple subcutaneous insulin injections or an insulin pump.
• Users of a continuous glucose monitor.

Exclusion criteria

• Common for both groups:
• Pregnancy.
• Mobile device which is incompatible with the WARIFA app (E.g. Apple devices).
• Unable to understand any of the app languages (Spanish, English, Norwegian or Romanian).
• Any reason which precludes follow-up, based on the researcher's criteria.
• Group 1: General population
• People with two or more NCDs.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

Spain · 1 center

• Instituto Universitario De Investigaciones Biomédicas y Sanitarias (IUIBS) — Las Palmas de Gran Canaria

Publications

• Betancort Acosta C, Zamora Zamorano G, Alvarez Male ML, Perestelo-Perez L, Torres Castano A, Veierod MB, Reyes Suarez K, Deniz Garcia A, Arsand E, Torhild Gram I, Lochen ML, Soguero-Ruiz C, Henriksen A, Rodriguez Almeida AJ, Muzny M, Valimaki R, Schopf T, Fabelo H, Granja C, Wagner AM. Effect of a Personalized Mobile Health Intervention Using Artificial Intelligence (the WARIFA App) Versus a Nonpe PMID 42172625

Identifiers

NCT: NCT06918444 · 2024-330-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗