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临床试验/NCT07505459
NCT07505459尚未招募不适用

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

Aikaterini Karaivazoglou3 个研究点 分布在 3 个国家目标入组 840 人开始时间: 2027年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
840
试验地点
3
主要终点
Food Frequency Questionnaire

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy individuals aged 12-25 yrs -

排除标准

  • Obesity Severe cognitive and communication deficits

研究组 & 干预措施

Standard peer-mentoring

Active Comparator

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

干预措施: Health Education (Other)

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

干预措施: AI-informed behavioral intervention (Behavioral)

Health educational intervention

Active Comparator

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

干预措施: Standard behavioral intervention (Behavioral)

结局指标

主要结局

Food Frequency Questionnaire

时间窗: From study enrollment to study completion at 12 months

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

KIDMED INDEX

时间窗: From study enrollment to study completion at 12 months

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

Accelerations measurement

时间窗: From study enrollment to study completion at 12 months

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

Healthy Diet Index

时间窗: From study enrollment to study completion at 12 months

It is a measure of diet quality

Steps measurement

时间窗: From study enrollment to study completion at 12 months

Number of steps per dayy measured by an accelerometer

International Physical Activity Questionnaire (IPAQ)

时间窗: From study enrollment to study completion at 12 months

It is an instrument that assesses the level of physical activity

PACER

时间窗: From study enrollment to study completion at 12 months

Measurement of cardiorespiratory fitness

次要结局

  • 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)
  • KIDSCREEN-27(From study enrollment to study completion at 12 months)
  • SF36(From study enrollment to study completion at 12 months)
  • Pittsburgh Sleep Quality Index AYA(From study enrollment to study completion at 12 months)
  • Screen-time Questionnaire(From study enrollment to study completion at 12 months)
  • Multidimensional Scale of Perceived Social Support(From study enrollment to study completion at 12 months)
  • General Self-Efficacy Scale(From study enrollment to study completion at 12 months)
  • Emotional Regulation Questionnaire, adults and children & adolescent versions(From study enrollment to study completion at 12 months)
  • Primarily fat mass(From study enrollment to study completion at 12 months)
  • Lean muscle mass(From study enrollment to study completion at 12 months)
  • Body water(From study enrollment to study completion at 12 months)
  • Bone density(From study enrollment to study completion at 12 months)
  • Arterial Blood Pressure(From study enrollment to study completion at 12 months)
  • Heart Rate Variability(From study enrollment to study completion at 12 months)

研究者

发起方
Aikaterini Karaivazoglou
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aikaterini Karaivazoglou

Assistant Professor of Child and Adolescent Psychiatry

University of Patras

研究点 (3)

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