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Starting soon Not applicable

AI-INFORMED PEER-MENTORING BEHAVIORAL INTERVENTION FOR OBESITY AND CARDIOVASCULAR DISEASE PRIMARY PREVENTION IN YOUTH

NCT07505459 · tracked via the Priya Life Science Italy tracker
Sponsor
Aikaterini Karaivazoglou
Phase
Not applicable
Started
2027-09-01
Last updated
2026-04-14

Condition(s) studied

Obesity (Disorder)

Investigational drug(s) / intervention(s)

AI-informed behavioral interventionStandard behavioral interventionHealth Education

AI-informed behavioral intervention: A hybrid, human-delivered peer-mentoring intervention, combining in-person and remote interactions and supported by AI-informed tools that provide mentors with access to ethically governed, privacy-preserving participant indicators. The intervention will operate under a supervisor-in-the-loop model, ensuring participant safety, intervention quality and ethical compliance, mentor support, and timely escalation to professional care when risks exceed the scope of peer support.

Standard behavioral intervention: Standard in-person behavioral intervention

Health Education: Regular professional-delivered health educational sessions on nutrition and physical activity

Study summary

The goal of this clinical trial is to learn if an AI-based peer-mentoring works to prevent obesity in adolescents and young adults. The main questions it aims to answer are:

Does the AI-based peer-mentoring improve dietary habits and increase physical activity in healthy individuals 12-25 yrs old? Does the AI-based peer-mentoring reduces the risk of obesity?

Researchers will compare the AI-based behavioral peer-mentoring intervention to traditional peer-mentoring and to health education intervention to see if AI-based peer-mentoring is more effective.

Participants will:

Follow either a structured AI-based peer-mentoring program or a traditional peer-mentoring program or health education sessions focusing on diet and physical activity They will be evaluated at baseline, at 6 months and at 12 months

Eligibility

Sex
ALL
Min age
12 Years
Max age
25 Years
Healthy volunteers
Accepted
Inclusion Criteria: Healthy individuals aged 12-25 yrs - Exclusion Criteria: Obesity Severe cognitive and communication deficits \-

Primary outcome measure(s)

  • Food Frequency Questionnaire — From study enrollment to study completion at 12 months
    Self- or parent-reported questionnaire on the consumption of several food categories
  • KIDMED INDEX — From study enrollment to study completion at 12 months
    A questionnaire used to measure adherence to the Mediterranean diet in children and adolescents
  • Accelerations measurement — From study enrollment to study completion at 12 months
    Measurement of accelerations through an accelerometer to evaluate the degree of physical activity
  • Healthy Diet Index — From study enrollment to study completion at 12 months
    It is a measure of diet quality
  • Steps measurement — From study enrollment to study completion at 12 months
    Number of steps per dayy measured by an accelerometer
  • International Physical Activity Questionnaire (IPAQ) — From study enrollment to study completion at 12 months
    It is an instrument that assesses the level of physical activity
  • PACER — From study enrollment to study completion at 12 months
    Measurement of cardiorespiratory fitness

Trial sites (3)

FacilityCityRegionStatus
University Hospital of Patras Pátrai Achaia
University of Bologna Modena Emilia-Romagna
Lulea Technical University Luleå Sweden
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07505459 on ClinicalTrials.gov ↗ ← All trials in Italy