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

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.

Study Overview

• Status: Recruiting
• Conditions: Lifestyle Intervention; Type 1 Diabetes (T1D); Non Communicable Chronic Diseases
• Intervention / Treatment: Device: WARIFA app with AI; Device: WARIFA app without AI

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Las Palmas
    • Las Palmas De Gran Canaria, Las Palmas, Spain, 35016
      • Recruiting
      • Instituto Universitario De Investigaciones Biomédicas y Sanitarias (IUIBS)
      • Contact: Juan Carmelo Betancort Acosta; Phone Number: +34 646068951; Email: carmelo.betancort@fpct.ulpgc.es
      • Contact: Ana Wägner, PhD
      • Contact: Juan Carmelo Betancort Acosta, MD
      • Contact: María Luisa Álvarez Malé, PhD
      • Contact: Garlene Zamora Zamorano
      • Contact: Kristina Reyes Suárez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Use of WARIFA app with artificial intelligence (AI); Participants will use a version of WARIFA app with artificial intelligence and personalized messages.	Device: 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.
Placebo Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of app use	Number of times users access the app (number of times per day). Direct adherence.	From enrollment to the end of intervention at 12 weeks
Time spent using the app	Time spent using the app (number of hours per day). Direct adherence.	From enrollment to the end of intervention at 12 weeks
Consistency in data recording	Assessment of the regularity with which users record information related to healthy habits, healthy eating and physical activity. Direct adherence.	From enrollment to the end of intervention at 12 weeks
ABACUS scale	The validated App Behaviour Change Scale (ABACUS). Attitudinal/Behavioural Change. The ABACUS scale was designed to measure the potential behavior change of apps. It consists of 21 items grouped into 4 categories: knowledge and information (5 items), goals and planning (3 items), feedback and monitoring (7 items), and actions (6 items). Each item represents a behavior change technique, and its inclusion in the app is rated dichotomously (behavior change technique not included = 0 or included = 1). Higher score means more potential behavioural change of apps.	At the enrollment and the end of intervention at 12 weeks
Changes in eating habits	Assessment of changes in diet quality (changes in consumption of fruits, vegetables, processed foods…). Diary recording of fruit, vegetable, and processed meat consumption will be used. Attitudinal/Behavioural Change.	From enrollment to the end of intervention at 12 weeks
Changes in physical activity	Data collected through a compatible smartwatch (number of steps) will be recorded. Attitudinal/Behavioural Change.	From enrollment to the end of intervention at 12 weeks
Reduction in tobacco consumption	Diary records of tobacco consumption will be used (number of cigarettes per day). Attitudinal/Behavioural Change.	From enrollment to the end of intervention at 12 weeks
Reduction in alcohol consumption	Diary records of alcohol consumption will be used (Number of units of alcoholic beverages per day). Attitudinal/Behavioural Change.	From enrollment to the end of intervention at 12 weeks
Changes in sun protection behaviour	sun habits questionnaire score wil be used. Attitudinal/Behavioural Change	At the enrollment and the end of intervention at 12 weeks
Changes in sun protection behaviour	Daily record of sunscreen use. Attitudinal/Behavioural Change	From enrollment to the end of intervention at 12 weeks
Hypoglycaemic events	The continuous glucose monitor data from participants will be used (number of hypoglycaemic events). Biomedical outcomes	From enrollment to the end of intervention at 12 weeks
Hypoglycaemic events	Diary records of manually recorded hypoglycaemic events (number of hypoglycaemic events). Biomedical outcomes.	From enrollment to the end of intervention at 12 weeks
Glycosylated haemoglobin	Will be measured in venous blood. Unit of measurement: %. Biomedical outcomes.	At the enrollment and the end of intervention at 12 weeks
Glucose Management Indicator	Glucose Management Indicator in the last 14 days. Unit of measurement: %. Biomedical outcome	From enrollment to the end of intervention at 12 weeks
Average glucose	Average glucose in the last 14 days. Unit of measurement: mg/dl. Biomedical outcomes.	From enrollment to the end of intervention at 12 weeks
Time in ranges	Times in glucose range for the last 14 days, measured by the participants' glucose sensor. Unit of measurement: %. Biomedical outcomes.	From enrollment to the end of intervention at 12 weeks
Total cholesterol	Total cholesterol, measured through a venous blood sample. Unit of measurement: mg/dl. Biomedical outcomes.	At the enrollment and the end of intervention at 12 weeks
HDL cholesterol	HDL cholesterol, measured through a venous blood sample. Unit of measurement: mg/dl. Biomedical outcomes.	At the enrollment and the end of intervention at 12 weeks
LDL cholesterol	LDL cholesterol, measured through a venous blood sample. Unit of measurement: mg/dl. Biomedical outcomes.	At the enrollment and the end of intervention at 12 weeks
Non-HDL cholesterol	Non-HDL cholesterol, measured through a venous blood sample. Unit of measurement: mg/dl. Biomedical outcomes.	At the enrollment and the end of intervention at 12 weeks
Muscle mass.	Muscle mass. Measured by impedanciometry. Unit of measurement: Kg. Biomedical outcomes.	At the enrollment and the end of intervention at 12 weeks
Fat mass	Fat mass. Measured by impedanciometry. Unit of measurement: Kg. Biomedical outcomes.	At the enrollment and the end of intervention at 12 weeks
Weight	Weight of each participant. Unit of measurement: Kg. Biomedical outcomes	At the enrollment and the end of intervention at 12 weeks
Height	Height of each participant. Unit of measurement: cm. Biomedical outcomes	At the enrollment
Circumference of abdomen.	Circumference of abdomen. Unit of measurement: cm. Biomedical outcomes	At the enrollment and the end of intervention at 12 weeks
Circumference of the calf	Circumference of the calf. Unit of measurement: cm. Biomedical outcomes	At the enrollment and the end of intervention at 12 weeks
Dynamometry	Functional test, using a dynamometer in each participant's hand. Unit of measurement: Kg. Biomedical outcomes	At the enrollment and the end of intervention at 12 weeks
Body fat.	Measured by plicometer in the posterior region of the upper arm (triceps area). Unit of measurement: mm. Biomedical outcomes.	At the enrollment and the end of intervention at 12 weeks
Chair test 5 repetitions	Functional test, which measures the time taken to stand up and sit down from a chair 5 times. Unit of measurement: seconds. Biomedical outcomes.	At the enrollment and the end of intervention at 12 weeks
Perceived quality of life	The EQ-5D questionnaire will be used for the group from the general population. Quality of Life and Wellbeing. Questionnaire with two distinct parts. The first part contains five health dimensions (mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression). For each dimension of the EQ-5D, severity levels are coded: 1 if the answer choice is 'no (I have) problems'; 2 if the answer choice is 'some or moderate problems'; and 3 if the answer choice is 'many problems'. The higher the score, the worse the health dimension. The second part of the EQ-5D is a scale from 0 to 100. On this scale, the individual should mark the point that best reflects their assessment of their overall health status, with 0 being the lowest assessment of their health status and 100 being the best.	At the enrollment and the end of intervention at 12 weeks
Perceived quality of life	The "Vida con Diabetes tipo 1" (ViDa1) questionnaire will be used for the group of individuals with T1D. Quality of Life and Wellbeing. The ViDa1 has 34 items that are grouped into 4 different dimensions: interference with life, self-care, well-being and worry about the disease. It is a questionnaire that can be self-administered with a Likert-type response format in which a total score per subscale is obtained. Interference with life: (items 1 - 12), self-care (13 - 23), well-being (24 - 29) and worry about illness (30 - 34). Each item is scored from 1 'strongly disagree' to 5 'strongly agree'. For correction, the scores obtained in each subscale are added together. Items 12, 23 and 27 are reversed for correct interpretation.	At the enrollment and the end of intervention at 12 weeks
Acquired knowledge	Assessment of new knowledge about healthy habits. The European Health Literacy Survey will be used. Knowledge and Attitudes. The questionnaire consists of 16 questions that classify the degree of difficulty perceived by the participant in each task or situation as: 1 'very easy', 2 'easy', 3 "difficult", 4 'very difficult' or 5 'don't know/no answer'.	At the enrollment and the end of intervention at 12 weeks
Self-efficacy	For measuring diabetes self-management behaviours, we will use the Summary of Diabetes Self-Care Activities (SDSCA). Knowledge and Attitudes. Is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen. It consists of 11 items that addresses different areas of self-care present in people with Diabetes Mellitus, such as diet, physical activity, medication, self-testing of capillary glycaemia and smoking. It presents a response scale from 0 to 7, depending on the number of days that the person has carried out a certain behaviour in the last week. The smoking item has a dichotomous response scale. The lower the score, the lower the adherence of the person with MD to favourable self-care behaviours. The questionnaire has no cut-off point, so each item must be assessed individually.	At the enrollment and the end of intervention at 12 weeks
Usability	Usability scale (SUS) will be used. Satisfaction and feedback. The SUS scale is a 10-item questionnaire scored on a 5-point Likert-type scale from 1 (strongly disagree) to 5 (strongly agree). It is arranged to alternate between positive and negative statements to avoid habitual bias from the respondent. The score contribution for the odd items (the positive statements) is the scale position minus 1 and the contribution for the even items (the negative statements) is 5 minus the scale position. The overall score is calculated from the sum of all item scores multiplied by 2.5, with the overall score ranging from 0 to 100. A system with a score above 85 is considered to have excellent usability, whereas a system with a score between 68 and 84 is considered to have good usability.	At the enrollment and the end of intervention at 12 weeks
Usability	The mHealth App Usability Questionnaire (MAUQ) will be used. Satisfaction and feedback. It assesses the ease of use, interface, satisfaction and usefulness of mHealth applications for end users. Consists of 18 items, with 7 response options for each item, ranging from 1 "strongly disagree" to 7 "strongly agree".	At the enrollment and the end of intervention at 12 weeks

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• WARIFA project home page

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): May 29, 2025
• Study Completion (Estimated): May 29, 2025

Study Registration Dates

• First Submitted: October 6, 2024
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Lifestyle intervention; Mobile app; Risk Prediction Model; Type 1 Diabetes (T1D); AI (Artificial Intelligence); Non Communicable Chronic Diseases
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Disease Attributes; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Noncommunicable Diseases; Diabetes Mellitus, Type 1; Chronic Disease
• Other Study ID Numbers: 2024-330-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study will be conducted in three European countries, in compliance with both national and European data protection laws.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No