Clinical Trial

Multi-Modal Digital Interventions for Adolescent Weight Management

Study acronym: M2DI-AWM
Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-02.
Status change: Not Yet Recruiting → Recruiting 2026-04-06
Trial Details
NCT Number NCT06920862
Lead Sponsor National Yang Ming Chiao Tung University
Conditions Obesity, Adolescent, Weight Change, Body, Weight Stigma
Enrollment 200 participants
Start Date 2025-08-01
Primary Completion 2028-07-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-13