Lifestyle Intervention, Non Communicable Chronic Diseases, Type 1 Diabetes (T1D)
Conditions
Keywords
AI (Artificial Intelligence), Mobile app, Lifestyle intervention, Non Communicable Chronic Diseases, Risk Prediction Model, Type 1 Diabetes (T1D)
Brief 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). 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.
Interventions
DEVICEWARIFA 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.
DEVICEWARIFA 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.
Sponsors
Complejo Hospitalario Universitario Insular Materno Infantil
Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-defined goal by the participants | 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
| Measure | Time frame | Description |
|---|---|---|
| Time spent using the app | From enrollment to the end of intervention at 12 weeks | Time spent using the app (number of hours per day). Direct adherence. |
| Consistency in data recording | 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. |
| ABACUS scale | 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. |
| Changes in eating habits | 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. |
| Changes in physical activity | 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. |
| Reduction in tobacco consumption | 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. |
| Reduction in alcohol consumption | 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. |
| Changes in sun protection behaviour | At the enrollment and the end of intervention at 12 weeks | sun habits questionnaire score wil be used. Attitudinal/Behavioural Change |
| Hypoglycaemic events | 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 |
| Glycosylated haemoglobin | At the enrollment and the end of intervention at 12 weeks | Will be measured in venous blood. Unit of measurement: %. Biomedical outcomes. |
| Glucose Management Indicator | From enrollment to the end of intervention at 12 weeks | Glucose Management Indicator in the last 14 days. Unit of measurement: %. Biomedical outcome |
| Average glucose | From enrollment to the end of intervention at 12 weeks | Average glucose in the last 14 days. Unit of measurement: mg/dl. Biomedical outcomes. |
| Time in ranges | 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. |
| Total cholesterol | 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. |
| HDL cholesterol | 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. |
| Frequency of app use | From enrollment to the end of intervention at 12 weeks | Number of times users access the app (number of times per day). Direct adherence. |
| Non-HDL cholesterol | 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. |
| Muscle mass. | At the enrollment and the end of intervention at 12 weeks | Muscle mass. Measured by impedanciometry. Unit of measurement: Kg. Biomedical outcomes. |
| Fat mass | At the enrollment and the end of intervention at 12 weeks | Fat mass. Measured by impedanciometry. Unit of measurement: Kg. Biomedical outcomes. |
| Weight | At the enrollment and the end of intervention at 12 weeks | Weight of each participant. Unit of measurement: Kg. Biomedical outcomes |
| Height | At the enrollment | Height of each participant. Unit of measurement: cm. Biomedical outcomes |
| Circumference of abdomen. | At the enrollment and the end of intervention at 12 weeks | Circumference of abdomen. Unit of measurement: cm. Biomedical outcomes |
| Circumference of the calf | At the enrollment and the end of intervention at 12 weeks | Circumference of the calf. Unit of measurement: cm. Biomedical outcomes |
| Dynamometry | 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 |
| Body fat. | 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. |
| Chair test 5 repetitions | 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. |
| Perceived quality of life | 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. |
| Acquired knowledge | 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'. |
| Self-efficacy | 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. |
| Usability | 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. |
| LDL cholesterol | 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. |
Countries
Spain
Outcome results
None listed