Multi-Modal Digital Interventions for Adolescent Weight Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorNational Yang Ming Chiao Tung University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Multi-Modal Digital Intervention
BehavioralParticipants 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Multi-Modal Digital Intervention GroupExperimental treatment 1 intervention
Group B: Control Group (General Health Education)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (T0), 1 month post-intervention (T1), 3 months post-intervention (T2)2
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.
Time frame
Baseline (T0), 1 month post-intervention (T1), and 3 months post-intervention (T2)Secondary outcomes
1
Change in TPB Constructs (Attitude, Subjective Norm, and Perceived Behavioral Control) as Measured by the Theory of Planned Behavior (TPB) Questionnaire
This outcome measures changes in three key cognitive constructs-attitude, subjective norm, and perceived behavioral control-regarding weight control behaviors among adolescents. These constructs are assessed using a validated Theory of Planned Behavior (TPB) Questionnaire, developed and tested in prior adolescent obesity studies. Each construct is measured using multiple items rated on a 7-point Likert scale (ranging from -3 = strongly disagree to +3 = strongly agree). Higher scores indicate more favorable attitudes, stronger perceived social support (subjective norm), and greater confidence in one's ability to perform weight control behaviors (perceived behavioral control). Changes will be reported as mean score differences from baseline at T1 and T2 for each construct separately.
Time frame
Baseline (T0), 1 month (T1), and 3 months (T2) post-intervention2
Change in Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated using measured weight (kg) and height (m) (BMI = kg/m²). Measurements will be taken using standardized digital scales and stadiometers. Changes in BMI will be analyzed as the mean difference from baseline to post-intervention to evaluate changes in body weight status.
Time frame
Baseline (T0) and 3 months post-intervention (T2)3
Change in Body Fat Mass (kg) as Measured by InBody 770
This outcome measures changes in total body fat mass (kg) using InBody 770, a validated bioelectrical impedance analysis (BIA) device. Fat mass will be reported in kilograms, and changes will be analyzed as mean difference from baseline.
Time frame
Baseline (T0) and 3 months post-intervention (T2)4
Change in Lean Body Mass (kg) as Measured by InBody 770
This outcome assesses changes in lean body mass (kg), also measured using the InBody 770 device. Lean mass includes muscle and other non-fat tissue. Results will be reported as mean change from baseline.
Time frame
Baseline (T0) and 3 months post-intervention (T2)Sponsors and contacts
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Source ClinicalTrials.gov