An interventional study of WARIFA app with AI and WARIFA app without AI in Lifestyle Intervention, Non Communicable Chronic Diseases and Type 1 Diabetes (T1D), sponsored by Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las · Not applicable, Interventional, and Prevention
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.
131 studies on the registry are indexed under Noncommunicable Diseases; 46 are open to participants now.
This study's planned enrollment of 104 is below the median of 600 across 86 interventional studies indexed under Noncommunicable Diseases.
Browse Noncommunicable Diseases studies →This is the only study on the registry with Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las as lead sponsor.
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Exclusion Criteria:
Participants will use a version of WARIFA app with artificial intelligence and personalized messages.
Device: WARIFA app with 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 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.
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.
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').
Time frame: At the end of intervention at 12 weeks
Frequency of app use
Number of times users access the app (number of times per day). Direct adherence.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: At the enrollment and the end of intervention at 12 weeks
Changes in sun protection behaviour
Daily record of sunscreen use. Attitudinal/Behavioural Change
Time frame: 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
Time frame: 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.
Time frame: From enrollment to the end of intervention at 12 weeks
Glycosylated haemoglobin
Will be measured in venous blood. Unit of measurement: %. Biomedical outcomes.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the enrollment and the end of intervention at 12 weeks
Muscle mass.
Muscle mass. Measured by impedanciometry. Unit of measurement: Kg. Biomedical outcomes.
Time frame: At the enrollment and the end of intervention at 12 weeks
Fat mass
Fat mass. Measured by impedanciometry. Unit of measurement: Kg. Biomedical outcomes.
Time frame: At the enrollment and the end of intervention at 12 weeks
Weight
Weight of each participant. Unit of measurement: Kg. Biomedical outcomes
Time frame: At the enrollment and the end of intervention at 12 weeks
Height
Height of each participant. Unit of measurement: cm. Biomedical outcomes
Time frame: At the enrollment
Circumference of abdomen.
Circumference of abdomen. Unit of measurement: cm. Biomedical outcomes
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: At the enrollment and the end of intervention at 12 weeks
Plan to share: No — The study will be conducted in three European countries, in compliance with both national and European data protection laws.
Started Feb 2025 (actual). Primary completion is estimated for May 2025, 3 months after the start.
Of 70 non-industry interventional studies with no phase under Noncommunicable Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 3 months is below that.
Counting every sponsor, half of 70 studies reached it within 16 months; a quarter within 8 and three quarters within 31.
Noncommunicable Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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