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NCT06918444Recruiting

Evaluation of the WARIFA App and Its Impact on Healthy Lifestyle

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

Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
104 (estimated)
First submitted
6 Oct 2024
Start date
24 Feb 2025
Primary completion date
29 May 2025
Lead sponsor
Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las
NCT number
NCT06918444

What you commit to

  • Study type: Interventional
  • Planned participants: 104
  • From 24 Feb 2025 to the primary completion date, 29 May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Universitario De Investigaciones Biomédicas y Sanitarias (IUIBS)
Coordinator of this site? Confirm its status
Las Palmas de Gran CanariaSpainRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.