Evaluation of the WARIFA App and Its Impact on Healthy Lifestyle
NCT ID: NCT06918444
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
104 participants
INTERVENTIONAL
2025-02-24
2025-05-29
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Use of WARIFA app with artificial intelligence (AI)
Participants will use a version of WARIFA app with artificial intelligence and personalized messages.
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.
Use of WARIFA app without artificial intelligence (AI)
Participants will use a version of WARIFA app with the same functionalities as the intervention group, but without artificial intelligence and personalized messages.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Complejo Hospitalario Universitario Insular Materno Infantil
OTHER
Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las
OTHER
Responsible Party
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Rosa María Sánchez Hernández
MD, PhD
Locations
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Instituto Universitario De Investigaciones Biomédicas y Sanitarias (IUIBS)
Las Palmas de Gran Canaria, Las Palmas, Spain
Countries
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Facility Contacts
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Related Links
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WARIFA project home page
Other Identifiers
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2024-330-1
Identifier Type: -
Identifier Source: org_study_id
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