Not Yet RecruitingNot Applicable

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

Greece, Italy, Sweden840 participantsStarted 2027-09-01

Plain-language 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

Who can participate

Age range

12 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Food Frequency Questionnaire

Timeframe: From study enrollment to study completion at 12 months

KIDMED INDEX

Timeframe: From study enrollment to study completion at 12 months

Accelerations measurement

Timeframe: From study enrollment to study completion at 12 months

Healthy Diet Index

Timeframe: From study enrollment to study completion at 12 months

Steps measurement

Timeframe: From study enrollment to study completion at 12 months

International Physical Activity Questionnaire (IPAQ)

Timeframe: From study enrollment to study completion at 12 months

PACER

Timeframe: From study enrollment to study completion at 12 months

Trial details

NCT IDNCT07505459

SponsorAikaterini Karaivazoglou

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-30

Contact for this trial

Luca Arcangeli, Dr

00393290743408 pm@innovate.clust-er.it

View on ClinicalTrials.gov More Obesity (Disorder) trials

Plain-language summary

Who can participate

Age range

12 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Food Frequency Questionnaire

Timeframe: From study enrollment to study completion at 12 months

KIDMED INDEX

Timeframe: From study enrollment to study completion at 12 months

Accelerations measurement

Timeframe: From study enrollment to study completion at 12 months

Healthy Diet Index

Timeframe: From study enrollment to study completion at 12 months

Steps measurement

Timeframe: From study enrollment to study completion at 12 months

International Physical Activity Questionnaire (IPAQ)

Timeframe: From study enrollment to study completion at 12 months

PACER

Timeframe: From study enrollment to study completion at 12 months