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| Name | Class |
|---|---|
| Complejo Hospitalario Universitario Insular Materno Infantil | OTHER |
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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.
The study will evaluate the app in two different populations:
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of WARIFA app with artificial intelligence (AI) | Experimental | Participants will use a version of WARIFA app with artificial intelligence and personalized messages. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Universitario De Investigaciones Biomédicas y Sanitarias (IUIBS) | Recruiting | Las Palmas de Gran Canaria | Las Palmas | 35016 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42172625 | Derived | 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. |
| Label | URL |
|---|---|
| WARIFA project home page | View source |
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The study will be conducted in three European countries, in compliance with both national and European data protection laws.
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| ID | Term |
|---|---|
| D000073296 | Noncommunicable Diseases |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
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| 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. |
|
| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |