Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06918444

Effect of the WARIFA App on User-defined Objectives, Healthy Lifestyles and Management of Type 1 Diabetes: a Pilot Randomised Controlled Trial

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

On this page

Sponsors

I

Instituto Universitario de Investigaciones Biomédicas y Sanitarias (iUIBS) de la Universidad de Las

Lead Sponsor

C

Complejo Hospitalario Universitario Insular Materno Infantil

Collaborating Sponsor

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults over 18 years of age
  • 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
Not Eligible

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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 1 location

1

Instituto Universitario De Investigaciones Biomédicas y Sanitarias (IUIBS)

Las Palmas de Gran Canaria, Las Palmas, Spain, 35016

Actively Recruiting

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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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Frequently Asked Questions

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