Clinical trial

Multi-Modal Digital Interventions for Adolescent Weight Management

Recruiting now · Not applicable · 1 countries · Registry ID NCT06920862

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 18 Years

SexAll

Healthy volunteersAccepted

ConditionObesity, Adolescent, Weight Change, Body, Weight Stigma

Full registry criteria

Inclusion Criteria: * 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 Criteria: * 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.

Treatments and study arms

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.

Primary outcomes

Change in Healthy Weight Control Behaviors as Measured by the Weight Control Behavior (WCB) ScaleBaseline (T0), 1 month post-intervention (T1), 3 months post-intervention (T2)

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.

Change in Unhealthy Weight Control Behaviors as Measured by the Weight Control Behavior (WCB) ScaleBaseline (T0), 1 month post-intervention (T1), and 3 months post-intervention (T2)

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.

Study locations

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National Yang Ming Chiao Tung University🇹🇼 Hsinchu, Taiwan

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Peiching LiuContact

Email · Call 886928528070

National Yang Ming Chiao Tung University🇹🇼 Taipei, Taiwan

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Peiching LiuContact

Email · Call +886928528070