RecruitingNot ApplicableNCT06920862

Multi-Modal Digital Interventions for Adolescent Weight Management

Effectiveness of Multi-Modal Digital Interventions for Adolescent Weight Management: A Randomized Controlled Trial

Sponsor

National Yang Ming Chiao Tung University

Enrollment

200 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity, Adolescent Weight Change, Body

Summary

The goal of this randomized controlled trial is to evaluate the effectiveness of a multi-modal digital intervention, based on the Theory of Planned Behavior (TPB), in promoting healthy weight control behaviors among overweight and obese adolescents. This study also aims to reduce the risk of unhealthy weight control behaviors by leveraging artificial intelligence-driven coaching, interactive platforms, gamified applications, and real-time feedback mechanisms. The main questions this study aims to answer are: 1. Can a multi-modal digital intervention effectively modify adolescents' primary beliefs underlying TPB constructs (attitude, subjective norms, and perceived behavioral control)? 2. How do TPB constructs influence weight control intentions, and how do these intentions translate into either healthy or unhealthy weight control behaviors? What role do adolescents' body image, body satisfaction, and mental health play in moderating the relationship between weight control intention and behavior? Participants will: 1. Be adolescents aged 12-18 years with a BMI ≥ 85th percentile. 2. Be randomly assigned to either the intervention group (multi-modal digital intervention) or the control group (general health education). 3. Engage in AI-driven coaching, interactive digital sessions, and gamified experiences tailored to TPB constructs. 4. Complete biweekly sessions over a period of three months (each session lasting two hours). 5. Receive personalized feedback and real-time monitoring through the Virti platform. 6. Participate in follow-up assessments at one month and three months post-intervention. Researchers will compare the intervention group to the control group to determine whether the multi-modal digital intervention leads to a higher adoption of healthy weight control behaviors and a lower prevalence of unhealthy weight control behaviors.

Eligibility

Min Age: 12 YearsMax Age: 18 Years

Inclusion Criteria5

Adolescents aged 12-18 years.
Body Mass Index (BMI) ≥ 85th percentile according to the Health Promotion Administration (HPA) standards.
Willing to participate in a digital intervention for weight control.
At least one parent or guardian provides consent for participation.
Able to understand and use digital devices (smartphones, tablets, or computers).

Exclusion Criteria5

Significant communication barriers (e.g., severe speech, hearing, or cognitive impairments).
Psychiatric disorders that affect interpersonal interaction (e.g., schizophrenia, severe depression).
Previous negative experiences with digital health interventions (VR or AI-based coaching).
Severe motion sickness that affects the ability to use VR-based tools.
Currently enrolled in another weight management program that may interfere with study outcomes.

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Interventions

BEHAVIORALMulti-Modal Digital Intervention

Participants in this group will receive a multi-modal digital intervention designed to enhance healthy weight control behaviors among overweight and obese adolescents. 1. The intervention integrates AI-driven coaching, interactive platforms, gamified applications, and real-time feedback mechanisms. 2. Participants will complete biweekly intervention sessions (2 hours each) over a 3-month period. 3. The intervention is grounded in the Theory of Planned Behavior (TPB) to target attitudes, subjective norms, and perceived behavioral control regarding weight control behaviors. 4. Participants will have access to the Virti platform, where they will receive personalized guidance and feedback.