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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity (Disorder)
• Intervention / Treatment: Behavioral: AI-informed behavioral intervention; Other: Health Education; Behavioral: Standard behavioral intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 840
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luca Arcangeli, Dr; Phone Number: 00393290743408; Email: pm@innovate.clust-er.it

Study Locations

• Greece
  • Achaia
    • Pátrai, Achaia, Greece, 26500
      • University Hospital of Patras
      • Contact: Aikaterini Karaivazoglou, PhD, Assistant Professor; Phone Number: 00306977711259; Email: karaivaz@hotmail.com
• Italy
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy
      • University of Bologna
      • Contact: Eliana Tossani, Professor; Phone Number: +39 3290743408; Email: eliana.tossani2@unibo.it
• Sweden
  • Luleå, Sweden
    • Lulea Technical University
    • Contact: Anna-Karin Lindqvist, Professor; Phone Number: 0046703611507; Email: anna-karin.lindqvist@ltu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Healthy individuals aged 12-25 yrs -

Exclusion Criteria:

Obesity Severe cognitive and communication deficits

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-informed peer-mentoring behavioral intervention; 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; 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.
Active Comparator: Standard peer-mentoring; Standard peer-mentoring program aiming at improving diet quality, increasing physical activity and reducing obesity risk	Other: Health Education; Regular professional-delivered health educational sessions on nutrition and physical activity
Active Comparator: Health educational intervention; Regular health education sessions delivered by professional educators which focus on nutrition and physical activity	Behavioral: Standard behavioral intervention; Standard in-person behavioral intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Measurement of body mass index	From study enrollment to study completion at 12 months
Waist circumference	Measurement of waist circumference	From study enrollment to study completion at 12 months
Lipidemic profile	Measurement of plasma total cholesterol, TGs, LDL, HDL, non-HDL, ApoB levels	From study enrollment to study completion at 12 months
Skin carotenoid levels	Spectroscopy-based measurement of skin carotenoid levels with the use of Veggie-Meter	From study enrollment to study completion at 12 months
25-OH D3	Measurement of 25-OH D3 plasma levels	From study enrollment to study completion at 12 months
KIDSCREEN-27	Assessment of quality of life	From study enrollment to study completion at 12 months
SF36	Assessment of quality of life	From study enrollment to study completion at 12 months
Pittsburgh Sleep Quality Index AYA	Self -reported questionnaire to assess of sleep quality	From study enrollment to study completion at 12 months
Screen-time Questionnaire	Self-reported questionnaire to assess screen-time	From study enrollment to study completion at 12 months
Multidimensional Scale of Perceived Social Support	It is a valid innstrument measuring support across three sources (family, friends, significant other)	From study enrollment to study completion at 12 months
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	From study enrollment to study completion at 12 months
Emotional Regulation Questionnaire, adults and children & adolescent versions	It is a valid and reliable instrument that assesses how people manage emotions	From study enrollment to study completion at 12 months
Primarily fat mass	It is an analysis of primarily fat mass with the use of bioelectrical impedance analysis	From study enrollment to study completion at 12 months
Lean muscle mass	It is the measurement of the body lean muscle mass with the use of bioelectrical impedance analysis	From study enrollment to study completion at 12 months
Body water	It is the measurement of body water with the use of bioelectrical impedance analysis	From study enrollment to study completion at 12 months
Bone density	It is the measurement of bone density with the use of bioelectrical impedance analysis	From study enrollment to study completion at 12 months
Arterial Blood Pressure	Measurement of arterial blood pressure	From study enrollment to study completion at 12 months
Heart Rate Variability	Measurement of heart rate and heart rate variability	From study enrollment to study completion at 12 months

Collaborators and Investigators

• Sponsor: Aikaterini Karaivazoglou
• Collaborators: University of Eastern Finland; Savonia University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: March 21, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Nutrition; Physical activity; prevention; Youth; Digital health; Behavioral change; Peer-mentoring
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Motor Activity
• Other Study ID Numbers: PMOBES140326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data regarding behaviors, medical information
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No