Multi-Modal Digital Interventions for Adolescent Weight Management

NCT06920862 | Recruiting

• 1 other identifier: NTYMCTU
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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. 1.Can a multi-modal digital intervention effectively modify adolescents' primary beliefs underlying TPB constructs (attitude, subjective norms, and perceived behavioral control)?
2. 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?
3. 3.Be adolescents aged 12-18 years with a BMI ≥ 85th percentile.
4. 4.Be randomly assigned to either the intervention group (multi-modal digital intervention) or the control group (general health education).
5. 5.Engage in AI-driven coaching, interactive digital sessions, and gamified experiences tailored to TPB constructs.
6. 6.Complete biweekly sessions over a period of three months (each session lasting two hours).
7. 7.Receive personalized feedback and real-time monitoring through the Virti platform.
8. 8.Participate in follow-up assessments at one month and three months post-intervention.

Conditions

Obesity, Adolescent; Weight Change, Body; Weight Stigma

Outcome Measures

Primary Outcomes (2)

• Change in Healthy Weight Control Behaviors as Measured by the Weight Control Behavior (WCB) Scale

  This outcome measures the change in healthy weight control behaviors among overweight and obese adolescents following the intervention. Healthy behaviors include increased physical activity, improved dietary habits (e.g., higher intake of fruits and vegetables), reduced consumption of sugary drinks, and portion control. Data will be collected using the healthy subscale of the Weight Control Behavior (WCB) Scale, a validated tool with a score range from 0 to 100. Higher scores reflect greater engagement in healthy weight control behaviors. Data will be analyzed as mean change from baseline at T1 and T2.

  Baseline (T0), 1 month post-intervention (T1), 3 months post-intervention (T2)

• Change in Unhealthy Weight Control Behaviors as Measured by the Weight Control Behavior (WCB) Scale

  This outcome measures the change in unhealthy weight control behaviors among overweight and obese adolescents following the intervention. Unhealthy behaviors include meal skipping, fasting, using diet pills or other weight-loss supplements, and extreme restriction. Data will be collected using the unhealthy subscale of the Weight Control Behavior (WCB) Scale, a validated tool with a score range from 0 to 100. Higher scores reflect greater frequency of unhealthy behaviors. Data will be analyzed as mean change from baseline at T1 and T2.

  Baseline (T0), 1 month post-intervention (T1), and 3 months post-intervention (T2)

Secondary Outcomes (7)

• Change in TPB Constructs (Attitude, Subjective Norm, and Perceived Behavioral Control) as Measured by the Theory of Planned Behavior (TPB) Questionnaire

  Baseline (T0), 1 month (T1), and 3 months (T2) post-intervention

• Change in Body Mass Index (BMI)

  Baseline (T0) and 3 months post-intervention (T2)

• Change in Body Fat Mass (kg) as Measured by InBody 770

  Baseline (T0) and 3 months post-intervention (T2)

• Change in Lean Body Mass (kg) as Measured by InBody 770

  Baseline (T0) and 3 months post-intervention (T2)

• Change in Body Image as Measured by the Multidimensional Body-Self Relations Questionnaire (MBSRQ)

  Baseline (T0) and 3 months post-intervention (T2)

Study Arms (2)

Multi-Modal Digital Intervention Group

EXPERIMENTAL

Participants in this group will receive a multi-modal digital intervention designed to enhance healthy weight control behaviors among overweight and obese adolescents. 1. Intervention Components: The intervention integrates AI-driven coaching, interactive platforms, gamified applications, and real-time feedback mechanisms. 2. Session Structure: Participants will complete biweekly intervention sessions (2 hours each) over a 3-month period. 3. Theoretical Framework: 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. Digital Platform: Participants will have access to the Virti platform, where they will receive personalized guidance and feedback.

Behavioral: Multi-Modal Digital Intervention

Control Group (General Health Education)

ACTIVE COMPARATOR

General Health Education sessions covering basic principles of nutrition, physical activity, and lifestyle modifications for weight management. These sessions will be delivered using traditional educational methods (e.g., brochures, videos, lectures).

Behavioral: Multi-Modal Digital Intervention

Interventions

Multi-Modal Digital Intervention BEHAVIORAL

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.

Control Group (General Health Education); Multi-Modal Digital Intervention Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (2)

National Yang Ming Chiao Tung University

Taipei, Taiwan, 112, Taiwan

RECRUITING

National Yang Ming Chiao Tung University

Hsinchu, 300, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Body Weight Changes; Weight Prejudice

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prejudice; Social Behavior; Behavior

Central Study Contacts

Peiching Liu, PhD

CONTACT

0928528070; ressyliu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 10, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 13, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)