Clinical trial

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

Opening soon · Not applicable · 3 countries · Registry ID NCT07505459

Opening soonNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 25 Years
SexAll
Healthy volunteersAccepted
ConditionObesity (Disorder)

Full registry criteria

Inclusion Criteria: Healthy individuals aged 12-25 yrs - Exclusion Criteria: Obesity Severe cognitive and communication deficits \-

Treatments and study arms

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.

Standard behavioral intervention

Behavioral

Standard in-person behavioral intervention

Health Education

Other

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

Primary outcomes

Food Frequency QuestionnaireFrom study enrollment to study completion at 12 months

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

KIDMED INDEXFrom study enrollment to study completion at 12 months

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

Accelerations measurementFrom study enrollment to study completion at 12 months

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

Healthy Diet IndexFrom study enrollment to study completion at 12 months

It is a measure of diet quality

Steps measurementFrom 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

PACERFrom study enrollment to study completion at 12 months

Measurement of cardiorespiratory fitness

Study locations

3 locations were listed when this page was built. The first 40 are shown.

University Hospital of Patras🇬🇷 Pátrai, Achaia, Greece
Aikaterini Karaivazoglou, PhD, Assistant ProfessorContact
University of Bologna🇮🇹 Modena, Emilia-Romagna, Italy
Eliana Tossani, ProfessorContact
Lulea Technical University🇸🇪 Luleå, Sweden
Anna-Karin Lindqvist, ProfessorContact