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

NCT07505459 | Not Yet Recruiting

• 1 other identifier: PMOBES140326
• Study Type: interventional
• Target: 840
• Locations: 3 countries
• Sites: 3

Brief 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

Conditions

Obesity (Disorder)

Keywords

Peer-mentoring; Obesity; Behavioral change; Nutrition; Physical activity; Youth; Digital health; prevention

Outcome Measures

Primary Outcomes (7)

• Food Frequency Questionnaire

  Self- or parent-reported questionnaire on the consumption of several food categories

  From study enrollment to study completion at 12 months

• KIDMED INDEX

  A questionnaire used to measure adherence to the Mediterranean diet in children and adolescents

  From study enrollment to study completion at 12 months

• Accelerations measurement

  Measurement of accelerations through an accelerometer to evaluate the degree of physical activity

  From study enrollment to study completion at 12 months

• Healthy Diet Index

  It is a measure of diet quality

  From study enrollment to study completion at 12 months

• Steps measurement

  Number of steps per dayy measured by an accelerometer

  From study enrollment to study completion at 12 months

• International Physical Activity Questionnaire (IPAQ)

  It is an instrument that assesses the level of physical activity

  From study enrollment to study completion at 12 months

• PACER

  Measurement of cardiorespiratory fitness

  From study enrollment to study completion at 12 months

Secondary Outcomes (18)

• BMI

  From study enrollment to study completion at 12 months

• Waist circumference

  From study enrollment to study completion at 12 months

• Lipidemic profile

  From study enrollment to study completion at 12 months

• Skin carotenoid levels

  From study enrollment to study completion at 12 months

• 25-OH D3

  From study enrollment to study completion at 12 months

Study Arms (3)

AI-informed peer-mentoring behavioral intervention

EXPERIMENTAL

AI-informed peer-mentoring program combining digitally facilitated peer mentoring, evidence-based behavioural interventions, and non-invasive self-monitoring technologies to support self-management, improve diet quality, increase physical activity and reduce the risk of obesity

Behavioral: AI-informed behavioral intervention

Standard peer-mentoring

ACTIVE COMPARATOR

Standard peer-mentoring program aiming at improving diet quality, increasing physical activity and reducing obesity risk

Other: Health Education

Health educational intervention

ACTIVE COMPARATOR

Regular health education sessions delivered by professional educators which focus on nutrition and physical activity

Behavioral: Standard behavioral intervention

Interventions

AI-informed behavioral intervention BEHAVIORAL

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.

AI-informed peer-mentoring behavioral intervention

Standard behavioral intervention BEHAVIORAL

Standard in-person behavioral intervention

Health educational intervention

Health Education OTHER

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

Standard peer-mentoring

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy individuals aged 12-25 yrs -

You may not qualify if:

• Obesity Severe cognitive and communication deficits

Sponsors & Collaborators

• Savonia University of Applied Sciences: collaborator
• Aikaterini Karaivazoglou: lead
• University of Eastern Finland: collaborator

Study Sites (3)

University Hospital of Patras

Pátrai, Achaia, 26500, Greece

Location

University of Bologna

Modena, Emilia-Romagna, Italy

Location

Lulea Technical University

Luleå, Sweden

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Luca Arcangeli, Dr

CONTACT

00393290743408; pm@innovate.clust-er.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Child and Adolescent Psychiatry

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: April 1, 2026
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

GR (1); IT (1); SE (1)