Evaluation of the WARIFA App and Its Impact on Healthy Lifestyle

NCT06918444 | Recruiting

• 1 other identifier: 2024-330-1
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

AI (Artificial Intelligence); Mobile app; Lifestyle intervention; Non Communicable Chronic Diseases; Risk Prediction Model; Type 1 Diabetes (T1D)

Outcome Measures

Primary Outcomes (1)

• Self-defined goal by the participants

  Degree of achievement of a self-defined goal by the participants (selected among: increase consumption on fruit and vegetables, increase physical activity, reduce alcohol consumption, stop smoking, reduce number of weekly hypoglycaemic episodes, or improve sun protective behaviours). It will be measured on a Likert scale, with scores ranging from 1 ('well below expectations') to 10 ('well above expectations').

  At the end of intervention at 12 weeks

Secondary Outcomes (35)

• Frequency of app use

  From enrollment to the end of intervention at 12 weeks

• Time spent using the app

  From enrollment to the end of intervention at 12 weeks

• Consistency in data recording

  From enrollment to the end of intervention at 12 weeks

• ABACUS scale

  At the enrollment and the end of intervention at 12 weeks

• Changes in eating habits

  From enrollment to the end of intervention at 12 weeks

Study Arms (2)

Use of WARIFA app with artificial intelligence (AI)

EXPERIMENTAL

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

Device: WARIFA app with AI

Use of WARIFA app without artificial intelligence (AI)

PLACEBO COMPARATOR

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

Device: WARIFA app without AI

Interventions

WARIFA app with AI DEVICE

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 with artificial intelligence (AI)

WARIFA app without AI DEVICE

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.

Use of WARIFA app without artificial intelligence (AI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las: lead
• Complejo Hospitalario Universitario Insular Materno Infantil: collaborator

Study Sites (1)

Instituto Universitario De Investigaciones Biomédicas y Sanitarias (IUIBS)

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

RECRUITING

Related Links

• WARIFA project home page

MeSH Terms

Conditions

Noncommunicable Diseases; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: April 9, 2025
• Study Start: February 24, 2025
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)