Lifestyle InterventionNCT06918444
Evaluation of the WARIFA App and Its Impact on Healthy Lifestyle
A study testing WARIFA app with AI and WARIFA app without AI in people with Lifestyle Intervention and Non Communicable Chronic Diseases, run by Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lifestyle Intervention, Non Communicable Chronic Diseases, Type 1 Diabetes (T1D)
- What is being tested?
- WARIFA app with AI and WARIFA app without AI
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 24 Feb 2025to 29 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Instituto Universitario De Investigaciones Biomédicas y Sanitarias (IUIBS)
Las Palmas de Gran Canaria, Las Palmas, 35016
Juan Carmelo Betancort Acosta, +34 646068951, carmelo.betancort@fpct.ulpgc.es
Ana Wägner, PhD
About this study
Official title: 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.
Read more
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.
- Being tested
- WARIFA app with AI, WARIFA app without AI
- Keywords
- AI (Artificial Intelligence), Mobile app, Lifestyle intervention, Non Communicable Chronic Diseases, Risk Prediction Model, Type 1 Diabetes (T1D)
- Medical subject headings
- Noncommunicable Diseases, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WARIFA app with AIDevice
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 AIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Use of WARIFA app with artificial intelligence (AI) | Experimental | Participants will use a version of WARIFA app with artificial intelligence and personalized messages. Receives: 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. Receives: Device: WARIFA app without AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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').
Measured: At the end of intervention at 12 weeks
Secondary outcomes (35)
Frequency of app use
Number of times users access the app (number of times per day). Direct adherence.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At the enrollment and the end of intervention at 12 weeks
Changes in sun protection behaviour
Daily record of sunscreen use. Attitudinal/Behavioural Change
Measured: 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
Measured: 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.
Measured: From enrollment to the end of intervention at 12 weeks
Glycosylated haemoglobin
Will be measured in venous blood. Unit of measurement: %. Biomedical outcomes.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the enrollment and the end of intervention at 12 weeks
Muscle mass.
Muscle mass. Measured by impedanciometry. Unit of measurement: Kg. Biomedical outcomes.
Measured: At the enrollment and the end of intervention at 12 weeks
Fat mass
Fat mass. Measured by impedanciometry. Unit of measurement: Kg. Biomedical outcomes.
Measured: At the enrollment and the end of intervention at 12 weeks
Weight
Weight of each participant. Unit of measurement: Kg. Biomedical outcomes
Measured: At the enrollment and the end of intervention at 12 weeks
Height
Height of each participant. Unit of measurement: cm. Biomedical outcomes
Measured: At the enrollment
Circumference of abdomen.
Circumference of abdomen. Unit of measurement: cm. Biomedical outcomes
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: At the enrollment and the end of intervention at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start24 Feb 2025
- Primary completion29 May 2025 (estimated)
- Study completion29 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lifestyle InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario Universitario Insular Materno Infantil
- Responsible party
- Principal investigator, Rosa María Sánchez Hernández, Complejo Hospitalario Universitario Insular Materno Infantil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918444
- Sponsor's protocol ID
- 2024-330-1
- Status last verified
- Apr 2025
- First submitted
- 6 Oct 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will be conducted in three European countries, in compliance with both national and European data protection laws.
Publications
Betancort Acosta C, Zamora Zamorano G, Alvarez Male ML, Perestelo-Perez L, Torres Castano A, Veierod MB, Reyes Suarez K, Deniz Garcia A, Arsand E, Torhild Gram I, Lochen ML, Soguero-Ruiz C, Henriksen A, Rodriguez Almeida AJ, Muzny M, Valimaki R, Schopf T, Fabelo H, Granja C, Wagner AM. Effect of a Personalized Mobile Health Intervention Using Artificial Intelligence (the WARIFA App) Versus a Nonpersonalized Intervention on User-Defined Objectives, Healthy Lifestyles, and Management of Type 1 Diabetes (T1D): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 May 22;15:e84510. doi: 10.2196/84510.
PubMed 42172625
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the WARIFA App on User-defined Objectives, Healthy Lifestyles and Management of Type 1 Diabetes: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06918444
- Acronym / sponsor ID
- 2024-330-1
- Keywords
- AI (Artificial Intelligence), Mobile app, Lifestyle intervention, Non Communicable Chronic Diseases, Risk Prediction Model, Type 1 Diabetes (T1D)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de LasUniversity, hospital or other
- Collaborators
- Complejo Hospitalario Universitario Insular Materno Infantil
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 29 May 2025 (estimated)
- Study completion
- 29 May 2025 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of WARIFA app with artificial intelligence (AI) | Experimental | Device: WARIFA app with AIParticipants will use a version of WARIFA app with artificial intelligence and personalized messages. |
| Use of WARIFA app without artificial intelligence (AI) | Placebo comparator | Device: WARIFA app without AIParticipants will use a version of WARIFA app with the same functionalities as the intervention group, but without artificial intelligence and personalized messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WARIFA app with AIParticipants 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. | Device | Use of WARIFA app with artificial intelligence (AI) |
| WARIFA app without AIParticipants 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. | Device | Use of WARIFA app without artificial intelligence (AI) |
Primary outcome
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').
35 secondary outcomes
Frequency of app use
Time frame: From enrollment to the end of intervention at 12 weeks
Time spent using the app
Time frame: From enrollment to the end of intervention at 12 weeks
Consistency in data recording
Time frame: From enrollment to the end of intervention at 12 weeks
ABACUS scale
Time frame: At the enrollment and the end of intervention at 12 weeks
Changes in eating habits
Time frame: From enrollment to the end of intervention at 12 weeks
Changes in physical activity
Time frame: From enrollment to the end of intervention at 12 weeks
Reduction in tobacco consumption
Time frame: From enrollment to the end of intervention at 12 weeks
Reduction in alcohol consumption
Time frame: From enrollment to the end of intervention at 12 weeks
Changes in sun protection behaviour
Time frame: At the enrollment and the end of intervention at 12 weeks
Changes in sun protection behaviour
Time frame: From enrollment to the end of intervention at 12 weeks
Hypoglycaemic events
Time frame: From enrollment to the end of intervention at 12 weeks
Hypoglycaemic events
Time frame: From enrollment to the end of intervention at 12 weeks
Glycosylated haemoglobin
Time frame: At the enrollment and the end of intervention at 12 weeks
Glucose Management Indicator
Time frame: From enrollment to the end of intervention at 12 weeks
Average glucose
Time frame: From enrollment to the end of intervention at 12 weeks
Time in ranges
Time frame: From enrollment to the end of intervention at 12 weeks
Total cholesterol
Time frame: At the enrollment and the end of intervention at 12 weeks
HDL cholesterol
Time frame: At the enrollment and the end of intervention at 12 weeks
LDL cholesterol
Time frame: At the enrollment and the end of intervention at 12 weeks
Non-HDL cholesterol
Time frame: At the enrollment and the end of intervention at 12 weeks
Muscle mass.
Time frame: At the enrollment and the end of intervention at 12 weeks
Fat mass
Time frame: At the enrollment and the end of intervention at 12 weeks
Weight
Time frame: At the enrollment and the end of intervention at 12 weeks
Height
Time frame: At the enrollment
Circumference of abdomen.
Time frame: At the enrollment and the end of intervention at 12 weeks
Circumference of the calf
Time frame: At the enrollment and the end of intervention at 12 weeks
Dynamometry
Time frame: At the enrollment and the end of intervention at 12 weeks
Body fat.
Time frame: At the enrollment and the end of intervention at 12 weeks
Chair test 5 repetitions
Time frame: At the enrollment and the end of intervention at 12 weeks
Perceived quality of life
Time frame: At the enrollment and the end of intervention at 12 weeks
Perceived quality of life
Time frame: At the enrollment and the end of intervention at 12 weeks
Acquired knowledge
Time frame: At the enrollment and the end of intervention at 12 weeks
Self-efficacy
Time frame: At the enrollment and the end of intervention at 12 weeks
Usability
Time frame: At the enrollment and the end of intervention at 12 weeks
Usability
Time frame: At the enrollment and the end of intervention at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Derived from this study: PubMed 42172625Betancort Acosta C, Zamora Zamorano G, Alvarez Male ML, Perestelo-Perez L, Torres Castano A, Veierod MB, Reyes Suarez K, Deniz Garcia A, Arsand E, Torhild Gram I, Lochen ML, Soguero-Ruiz C, Henriksen A, Rodriguez Almeida AJ, Muzny M, Valimaki R, Schopf T, Fabelo H, Granja C, Wagner AM. Effect of a Personalized Mobile Health Intervention Using Artificial Intelligence (the WARIFA App) Versus a Nonpersonalized Intervention on User-Defined Objectives, Healthy Lifestyles, and Management of Type 1 Diabetes (T1D): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 May 22;15:e84510. doi: 10.2196/84510.
- WARIFA project home pageLink provided by the sponsor.
- Individual participant dataSharing planned: No. The study will be conducted in three European countries, in compliance with both national and European data protection laws.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Instituto Universitario De Investigaciones Biomédicas y Sanitarias (IUIBS)
Las Palmas de Gran Canaria, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WARIFA app with AI and WARIFA app without AI in people with Lifestyle Intervention and Non Communicable Chronic Diseases, run by Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-defined goal by the participants (time frame: At the end of intervention at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06918444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.