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Obesity (Disorder)PeerMentorOBCVNCT07505459

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

A study testing AI-informed behavioral intervention, Standard behavioral intervention and Health Education in people with Obesity (Disorder), run by Aikaterini Karaivazoglou at 3 sites in 3 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Obesity (Disorder)
What is being tested?
AI-informed behavioral intervention, Standard behavioral intervention and Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
840 participants
Where
3 sitesin 3 countries
Study dates
1 Sep 2027to 30 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy individuals aged 12-25 yrs -

Who cannot join

  • Obesity Severe cognitive and communication deficits
  • -

Trial locations and contacts

3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Luca Arcangeli, Dr contact

00393290743408

pm@innovate.clust-er.it

3 sites in 3 countries

Greece1 site
  • University Hospital of Patras

    Pátrai, Achaia, 26500

    Aikaterini Karaivazoglou, PhD, Assistant Professor, 00306977711259, karaivaz@hotmail.com

Other trials in Greece

Italy1 site
  • University of Bologna

    Modena, Emilia-Romagna

    Eliana Tossani, Professor, +39 3290743408, eliana.tossani2@unibo.it

Other trials in Italy

Sweden1 site
  • Lulea Technical University

    Luleå

    Anna-Karin Lindqvist, Professor, 0046703611507, anna-karin.lindqvist@ltu.se

Other trials in Sweden

About this study

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?

Read more

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

Read the detailed description

Adolescence and young adulthood (12-25 years) represent critical developmental periods during which lifestyle patterns related to nutrition, physical activity, sleep, digital media use, social interaction, and stress regulation are consolidated and often persist into adulthood. Preventive interventions targeting these stages therefore offer substantial potential for long-term reduction of non-communicable disease (NCD) burden.

Although young people are often perceived as generally healthy, epidemiological evidence indicates a growing burden of NCD-related conditions in this population. Adolescent obesity has quadrupled in recent decades, affecting over 160 million children and adolescents worldwide (World Health Organization, 2021; Halilagic et al., 2025), and is strongly associated with increased risk of metabolic syndrome, type 2 diabetes, hypertension, cardiovascular disease (CVD), and certain cancers later in life (Shi et al., 2024).

A substantial body of evidence links obesity risk to modifiable lifestyle factors established early in life (Arnason et al., 2020; Zaman et al., 2019; Singh et al., 2025; Parvin et al., 2025), and behavioural interventions addressing these factors have demonstrated promising effects in young populations (Pastor et al., 2020; Ashton et al., 2019). However, existing interventions often show wide variability in design and outcomes and face persistent challenges related to long-term adherence, scalability, and equitable access (Melo et al., 2025; Talens et al., 2025). Many rely on professional-led delivery models requiring substantial human and financial resources, limiting their sustainability and reach, particularly in low-resource or geographically remote settings.

Digital health interventions have emerged as a promising means to improve accessibility and engagement while supporting self-monitoring and feedback. Digital approaches have demonstrated positive effects on behaviours related to physical activity, diet, and sleep (Singh et al., 2025). Nevertheless, many digital interventions remain largely individualised and screen-centric, insufficiently leveraging the social environments in which young people's behaviours are embedded, which may limit sustained engagement and long-term behaviour change.

In this context, peer mentoring represents a promising, yet, underutilised approach for strengthening behavioural self-management and primary NCD prevention among adolescents and young adults. Peer mentoring involves structured, supportive relationships in which individuals with shared or similar lived experiences provide guidance, encouragement, and role modelling. During adolescence and young adulthood, peers exert a strong influence on attitudes, norms, motivation, and behaviour. Peer-led approaches are often perceived as more relatable, credible, and emotionally safe than authority- or expert-led interventions, fostering trust, social connectedness, and intrinsic motivation (DuBois \& Karcher, 2014; Smith et al., 2016). Peer mentoring programs have demonstrated effectiveness in promoting healthy behaviours and psychosocial outcomes in youth, particularly in school-based and community settings (Lavelle et al., 2023).

For these reasons, the aim of the current study will be to implement and evaluate 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. More specifically, the intervention will include a structured school-based (adolescents) or campus- or community- based (young adults) behavioral change program delivered through peer-mentoring focusing on physical activity and nutrition in order to reduce obesity risk. The intervention' s content will be based on existing evidence-based interventions with a solid theoretical foundation (namely the Health Belief Model and Social Cognitive Theory). The program will recruit and appropriately train young mentors aged 14-25 years old. Mentors' training curriculum will be designed by experts in youth health (pediatrics, endocrinology), nutrition science, physiotherapy and behavioral science based on the aforementioned interventions and training will be performed through a pre-defined number of group sessions and is expected to be completed within a month. Subsequently, mentors will be matched with slightly younger peers (aged 12-23 years old) and they will deliver the intervention through structured weekly meetings and activities throughout the academic year. Each mentor-mentee pair will be supervised and supported by a qualified supervisor (psychologist or social worker) which will conduct regular meetings (twice a month) with each pair, will be available to support them during the study period and will ensure the program's implementation fidelity. The meetings and shared activities will take place at schools during the school curriculum for adolescents and at campuses or community centers for young adults. The program will be coordinated by a qualified professional which will support supervisors and will act as liaison between school and university personnel and supervisors.

Being tested
AI-informed behavioral intervention, Standard behavioral intervention, Health Education
Keywords
Peer-mentoring, Obesity, Behavioral change, Nutrition, Physical activity, Youth, Digital health, prevention
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI-informed behavioral interventionBehavioural

    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 interventionBehavioural

    Standard in-person behavioral intervention

  • Health EducationOther

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

Study groups in NCT07505459
Study groupRoleWhat they receive
AI-informed peer-mentoring behavioral interventionExperimentalAI-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
Receives: Behavioral: AI-informed behavioral intervention
Standard peer-mentoringActive comparatorStandard peer-mentoring program aiming at improving diet quality, increasing physical activity and reducing obesity risk
Receives: Other: Health Education
Health educational interventionActive comparatorRegular health education sessions delivered by professional educators which focus on nutrition and physical activity
Receives: Behavioral: Standard behavioral intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Food Frequency Questionnaire

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

    Measured: From study enrollment to study completion at 12 months

  2. KIDMED INDEX

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

    Measured: From study enrollment to study completion at 12 months

  3. Accelerations measurement

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

    Measured: From study enrollment to study completion at 12 months

  4. Healthy Diet Index

    It is a measure of diet quality

    Measured: From study enrollment to study completion at 12 months

  5. Steps measurement

    Number of steps per dayy measured by an accelerometer

    Measured: From study enrollment to study completion at 12 months

  6. International Physical Activity Questionnaire (IPAQ)

    It is an instrument that assesses the level of physical activity

    Measured: From study enrollment to study completion at 12 months

  7. PACER

    Measurement of cardiorespiratory fitness

    Measured: From study enrollment to study completion at 12 months

Secondary outcomes (18)
  1. BMI

    Measurement of body mass index

    Measured: From study enrollment to study completion at 12 months

  2. Waist circumference

    Measurement of waist circumference

    Measured: From study enrollment to study completion at 12 months

  3. Lipidemic profile

    Measurement of plasma total cholesterol, TGs, LDL, HDL, non-HDL, ApoB levels

    Measured: From study enrollment to study completion at 12 months

  4. Skin carotenoid levels

    Spectroscopy-based measurement of skin carotenoid levels with the use of Veggie-Meter

    Measured: From study enrollment to study completion at 12 months

  5. 25-OH D3

    Measurement of 25-OH D3 plasma levels

    Measured: From study enrollment to study completion at 12 months

  6. KIDSCREEN-27

    Assessment of quality of life

    Measured: From study enrollment to study completion at 12 months

  7. SF36

    Assessment of quality of life

    Measured: From study enrollment to study completion at 12 months

  8. Pittsburgh Sleep Quality Index AYA

    Self -reported questionnaire to assess of sleep quality

    Measured: From study enrollment to study completion at 12 months

  9. Screen-time Questionnaire

    Self-reported questionnaire to assess screen-time

    Measured: From study enrollment to study completion at 12 months

  10. Multidimensional Scale of Perceived Social Support

    It is a valid innstrument measuring support across three sources (family, friends, significant other)

    Measured: From study enrollment to study completion at 12 months

  11. General Self-Efficacy Scale

    It is a questionnaire designed to measure an individual's belief in their ability to manage difficult tasks and unforeseen situations

    Measured: From study enrollment to study completion at 12 months

  12. Emotional Regulation Questionnaire, adults and children & adolescent versions

    It is a valid and reliable instrument that assesses how people manage emotions

    Measured: From study enrollment to study completion at 12 months

  13. Primarily fat mass

    It is an analysis of primarily fat mass with the use of bioelectrical impedance analysis

    Measured: From study enrollment to study completion at 12 months

  14. Lean muscle mass

    It is the measurement of the body lean muscle mass with the use of bioelectrical impedance analysis

    Measured: From study enrollment to study completion at 12 months

  15. Body water

    It is the measurement of body water with the use of bioelectrical impedance analysis

    Measured: From study enrollment to study completion at 12 months

  16. Bone density

    It is the measurement of bone density with the use of bioelectrical impedance analysis

    Measured: From study enrollment to study completion at 12 months

  17. Arterial Blood Pressure

    Measurement of arterial blood pressure

    Measured: From study enrollment to study completion at 12 months

  18. Heart Rate Variability

    Measurement of heart rate and heart rate variability

    Measured: From study enrollment to study completion at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2026
  2. Study start1 Sep 2027 (estimated)
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
840 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07505459
Sponsor's protocol ID
PMOBES140326
Acronym
PeerMentorOBCV
Status last verified
Apr 2026
First submitted
21 Mar 2026
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized data regarding behaviors, medical information

Questions about this trial

What is this clinical trial studying?

A study testing AI-informed behavioral intervention, Standard behavioral intervention and Health Education in people with Obesity (Disorder), run by Aikaterini Karaivazoglou at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Greece, Italy, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Luca Arcangeli, Dr (00393290743408, pm@innovate.clust-er.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Food Frequency Questionnaire (time frame: From study enrollment to study completion at 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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