Pilot Study to Evaluate the WARIFA Apps Impact on Healthy Lifestyle and Type 1 Diabetes Management in Adults
Led by Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las · Updated on 2025-04-09
104
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What This Trial Is About
Researchers are evaluating the impact of the WARIFA app on promoting healthy lifestyle behaviors related to non-communicable diseases NCDs and managing Type 1 Diabetes T1D. This pilot randomized controlled trial studies how user-generated data, artificial intelligence, and risk estimation can provide personalized lifestyle recommendations through a mobile app. The study involves two groups adults with no more than one NCD and adults with T1D using insulin therapy and continuous glucose monitoring.
Participants will be randomly assigned to one of two groups. The intervention group will use the WARIFA app with artificial intelligence that analyzes their data to give personalized recommendations on lifestyle and disease risk. The control group will use a version of the app without artificial intelligence, which provides general lifestyle information based on WHO guidelines. Both groups will use the app for 12 weeks.
During the study, participants will complete questionnaires and physical exams including measurements like body composition and cholesterol levels at the start and after 12 weeks. Researchers will track app use, changes in health behaviors, glucose control, and quality of life. The main outcome is participants self-defined goals at 12 weeks. The study lasts 3 months per participant and is conducted at centers in Spain, Norway, and Romania.
CONDITIONS
Brief Title
Evaluation of the WARIFA App and Its Impact on Healthy Lifestyle
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Owners of an Android smartphone with internet access
For general population group: healthy or diagnosed with no more than one non-communicable disease (cardiovascular disease, any type of cancer, type 2 diabetes, or chronic respiratory disease)
For Type 1 Diabetes group: treatment with multiple subcutaneous insulin injections or an insulin pump
For Type 1 Diabetes group: users of a continuous glucose monitor
You will not qualify if you...
Pregnancy
Use of a mobile device incompatible with the WARIFA app (e.g., Apple devices)
Unable to understand any of the app languages (Spanish, English, Norwegian, or Romanian)
Any reason that precludes follow-up as determined by the researcher
For general population group: having two or more non-communicable diseases (NCDs)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 12 weeks
Participants use the WARIFA app on their mobile phones for 12 weeks. The app collects activity data, questionnaires, and diaries, providing information and recommendations about lifestyle and risks of chronic diseases. Some participants will receive personalized messages using artificial intelligence, while others will receive general information without AI.
Initial enrollment visit and ongoing app use for 12 weeks
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
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.
Carmelo Betancort Acosta, Garlene Zamora Zamorano, María Luisa Álvarez Malé...