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NCT Number: NCT06918444

Evaluation of the WARIFA App and Its Impact on Healthy Lifestyle

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Universitario De Investigaciones Biomédicas y Sanitarias (IUIBS)

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

Location status: Recruiting

Location contact

Ana Wägner, PhD

PRINCIPAL_INVESTIGATOR

Garlene Zamora Zamorano

SUB_INVESTIGATOR

Juan Carmelo Betancort Acosta

CONTACT

[email protected]

+34 646068951

Juan Carmelo Betancort Acosta, MD

SUB_INVESTIGATOR

Kristina Reyes Suárez

SUB_INVESTIGATOR

María Luisa Álvarez Malé, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Self-defined goal by the participants

    Time frame: At the end of intervention at 12 weeks

    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').

Secondary outcomes

  1. Frequency of app use

    Time frame: From enrollment to the end of intervention at 12 weeks

    Number of times users access the app (number of times per day). Direct adherence.

  2. Time spent using the app

    Time frame: From enrollment to the end of intervention at 12 weeks

    Time spent using the app (number of hours per day). Direct adherence.

  3. Consistency in data recording

    Time frame: From enrollment to the end of intervention at 12 weeks

    Assessment of the regularity with which users record information related to healthy habits, healthy eating and physical activity. Direct adherence.

  4. ABACUS scale

    Time frame: At the enrollment and the end of intervention at 12 weeks

    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.

  5. Changes in eating habits

    Time frame: From enrollment to the end of intervention at 12 weeks

    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.

  6. Changes in physical activity

    Time frame: From enrollment to the end of intervention at 12 weeks

    Data collected through a compatible smartwatch (number of steps) will be recorded. Attitudinal/Behavioural Change.

  7. Reduction in tobacco consumption

    Time frame: From enrollment to the end of intervention at 12 weeks

    Diary records of tobacco consumption will be used (number of cigarettes per day). Attitudinal/Behavioural Change.

  8. Reduction in alcohol consumption

    Time frame: From enrollment to the end of intervention at 12 weeks

    Diary records of alcohol consumption will be used (Number of units of alcoholic beverages per day). Attitudinal/Behavioural Change.

  9. Changes in sun protection behaviour

    Time frame: At the enrollment and the end of intervention at 12 weeks

    sun habits questionnaire score wil be used. Attitudinal/Behavioural Change

  10. Changes in sun protection behaviour

    Time frame: From enrollment to the end of intervention at 12 weeks

    Daily record of sunscreen use. Attitudinal/Behavioural Change

  11. Hypoglycaemic events

    Time frame: From enrollment to the end of intervention at 12 weeks

    The continuous glucose monitor data from participants will be used (number of hypoglycaemic events). Biomedical outcomes

  12. Hypoglycaemic events

    Time frame: From enrollment to the end of intervention at 12 weeks

    Diary records of manually recorded hypoglycaemic events (number of hypoglycaemic events). Biomedical outcomes.

  13. Glycosylated haemoglobin

    Time frame: At the enrollment and the end of intervention at 12 weeks

    Will be measured in venous blood. Unit of measurement: %. Biomedical outcomes.

  14. Glucose Management Indicator

    Time frame: From enrollment to the end of intervention at 12 weeks

    Glucose Management Indicator in the last 14 days. Unit of measurement: %. Biomedical outcome

  15. Average glucose

    Time frame: From enrollment to the end of intervention at 12 weeks

    Average glucose in the last 14 days. Unit of measurement: mg/dl. Biomedical outcomes.

  16. Time in ranges

    Time frame: From enrollment to the end of intervention at 12 weeks

    Times in glucose range for the last 14 days, measured by the participants' glucose sensor. Unit of measurement: %. Biomedical outcomes.

  17. Total cholesterol

    Time frame: At the enrollment and the end of intervention at 12 weeks

    Total cholesterol, measured through a venous blood sample. Unit of measurement: mg/dl. Biomedical outcomes.

  18. HDL cholesterol

    Time frame: At the enrollment and the end of intervention at 12 weeks

    HDL cholesterol, measured through a venous blood sample. Unit of measurement: mg/dl. Biomedical outcomes.

  19. LDL cholesterol

    Time frame: At the enrollment and the end of intervention at 12 weeks

    LDL cholesterol, measured through a venous blood sample. Unit of measurement: mg/dl. Biomedical outcomes.

  20. Non-HDL cholesterol

    Time frame: At the enrollment and the end of intervention at 12 weeks

    Non-HDL cholesterol, measured through a venous blood sample. Unit of measurement: mg/dl. Biomedical outcomes.

  21. Muscle mass.

    Time frame: At the enrollment and the end of intervention at 12 weeks

    Muscle mass. Measured by impedanciometry. Unit of measurement: Kg. Biomedical outcomes.

  22. Fat mass

    Time frame: At the enrollment and the end of intervention at 12 weeks

    Fat mass. Measured by impedanciometry. Unit of measurement: Kg. Biomedical outcomes.

  23. Weight

    Time frame: At the enrollment and the end of intervention at 12 weeks

    Weight of each participant. Unit of measurement: Kg. Biomedical outcomes

  24. Height

    Time frame: At the enrollment

    Height of each participant. Unit of measurement: cm. Biomedical outcomes

  25. Circumference of abdomen.

    Time frame: At the enrollment and the end of intervention at 12 weeks

    Circumference of abdomen. Unit of measurement: cm. Biomedical outcomes

  26. Circumference of the calf

    Time frame: At the enrollment and the end of intervention at 12 weeks

    Circumference of the calf. Unit of measurement: cm. Biomedical outcomes

  27. Dynamometry

    Time frame: At the enrollment and the end of intervention at 12 weeks

    Functional test, using a dynamometer in each participant's hand. Unit of measurement: Kg. Biomedical outcomes

  28. Body fat.

    Time frame: At the enrollment and the end of intervention at 12 weeks

    Measured by plicometer in the posterior region of the upper arm (triceps area). Unit of measurement: mm. Biomedical outcomes.

  29. Chair test 5 repetitions

    Time frame: At the enrollment and the end of intervention at 12 weeks

    Functional test, which measures the time taken to stand up and sit down from a chair 5 times. Unit of measurement: seconds. Biomedical outcomes.

  30. Perceived quality of life

    Time frame: At the enrollment and the end of intervention at 12 weeks

    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.

  31. Perceived quality of life

    Time frame: At the enrollment and the end of intervention at 12 weeks

    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.

  32. Acquired knowledge

    Time frame: At the enrollment and the end of intervention at 12 weeks

    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'.

  33. Self-efficacy

    Time frame: At the enrollment and the end of intervention at 12 weeks

    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.

  34. Usability

    Time frame: At the enrollment and the end of intervention at 12 weeks

    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.

  35. Usability

    Time frame: At the enrollment and the end of intervention at 12 weeks

    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".

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Complejo Hospitalario Universitario Insular Materno Infantil

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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