Evaluation of the WARIFA App and Its Impact on Healthy Lifestyle

Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las

Status: Enrolling

Conditions: Non Communicable Chronic Diseases; Type 1 Diabetes (T1D); Lifestyle Intervention

Treatments: Device: WARIFA app without AI; Device: WARIFA app with AI

Study type: Interventional

Funder types: Other

Identifiers

NCT06918444

2024-330-1

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

Use of WARIFA app with artificial intelligence (AI)

Experimental group

Description:

Participants will use a version of WARIFA app with artificial intelligence and personalized messages.

Treatment:

Device: WARIFA app with AI

Use of WARIFA app without artificial intelligence (AI)

Placebo Comparator group

Description:

Participants will use a version of WARIFA app with the same functionalities as the intervention group, but without artificial intelligence and personalized messages.

Treatment:

Device: WARIFA app without AI