Clinical trial NCT06918444: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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)
Lead sponsor: Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario Universitario Insular Materno Infantil
First posted: 2025-04-09
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Self-defined goal by the participants
timeFrame: At the end of intervention at 12 weeks
Secondary outcomes:
measure: Frequency of app use
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Time spent using the app
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Consistency in data recording
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: ABACUS scale
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Changes in eating habits
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Changes in physical activity
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Reduction in tobacco consumption
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Reduction in alcohol consumption
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Changes in sun protection behaviour
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Changes in sun protection behaviour
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Hypoglycaemic events
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Hypoglycaemic events
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Glycosylated haemoglobin
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Glucose Management Indicator
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Average glucose
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Time in ranges
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Total cholesterol
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: HDL cholesterol
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: LDL cholesterol
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Non-HDL cholesterol
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Muscle mass.
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Fat mass
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Weight
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Height
timeFrame: At the enrollment
measure: Circumference of abdomen.
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Circumference of the calf
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Dynamometry
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Body fat.
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Chair test 5 repetitions
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Perceived quality of life
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Perceived quality of life
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Acquired knowledge
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Self-efficacy
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Usability
timeFrame: At the enrollment and the end of intervention at 12 weeks
measure: Usability
timeFrame: At the enrollment and the end of intervention at 12 weeks
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Instituto Universitario De Investigaciones Biomédicas y Sanitarias (IUIBS)
state: Las Palmas
Study officials:
References: