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NCT06920862: M2DI-AWM
Multi-Modal Digital Interventions for Adolescent Weight Management
NA trial testing Multi-Modal Digital Intervention in Obesity, Adolescent in 200 participants. Currently enrolling.
31 July 2028
Quick facts
| Lead sponsor | National Yang Ming Chiao Tung University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 August 2025 |
| Primary completion | 31 July 2028 |
| Estimated completion | 31 December 2029 |
| Sites | 2 locations across Taiwan |
Drugs / interventions tested
- Multi-Modal Digital Intervention
Conditions studied
- Obesity, Adolescent — all drugs for Obesity, Adolescent →
- Weight Change, Body — all drugs for Weight Change, Body →
- Weight Stigma — all drugs for Weight Stigma →
Sponsor
National Yang Ming Chiao Tung University
Who can join
Adults 12 to 18, any sex, with Obesity, Adolescent or Weight Change, Body. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06920862
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06920862 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Yang Ming Chiao Tung University
- Last refreshed: 13 April 2026
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