Effectiveness of Multi-Modal Digital Interventions for Adolescent Weight Management: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Healthy Weight Control Behaviors as Measured by the Weight Control Behavior (WCB) Scale
研究概览
简要总结
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:
- Can a multi-modal digital intervention effectively modify adolescents' primary beliefs underlying TPB constructs (attitude, subjective norms, and perceived behavioral control)?
- 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:
- Be adolescents aged 12-18 years with a BMI ≥ 85th percentile.
- Be randomly assigned to either the intervention group (multi-modal digital intervention) or the control group (general health education).
- Engage in AI-driven coaching, interactive digital sessions, and gamified experiences tailored to TPB constructs.
- Complete biweekly sessions over a period of three months (each session lasting two hours).
- Receive personalized feedback and real-time monitoring through the Virti platform.
- 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.
详细描述
Adolescent obesity remains a global public health challenge with far-reaching implications for physical and psychological well-being. In Taiwan, the prevalence of overweight and obesity among adolescents aged 13-18 has exceeded 30%, mirroring trends observed worldwide. The COVID-19 pandemic has further exacerbated this issue, intensifying weight gain among youth due to disrupted routines, reduced physical activity, poor sleep hygiene, and increased consumption of energy-dense foods. Despite growing awareness and reported intentions to manage weight among adolescents, there remains a substantial gap between intention and sustained healthy behavior.
This study seeks to bridge this intention-behavior gap through the development and evaluation of a multi-modal digital intervention, grounded in the Theory of Planned Behavior (TPB). TPB posits that intention-the most proximal predictor of behavior-is influenced by three constructs: attitude, subjective norm, and perceived behavioral control. Each construct is shaped by a distinct set of beliefs, including behavioral, normative, and control beliefs. However, limited research has explored how these constructs interact to promote healthy weight control behaviors or inadvertently contribute to unhealthy practices such as meal skipping, purging, or misuse of diet pills.
Building on the PI's previous qualitative and quantitative studies validating TPB in Taiwanese adolescents with obesity, this project designs an intervention that targets these belief systems directly. The intervention integrates artificial intelligence-driven virtual coaching, virtual reality (VR)-based simulation scenarios, gamified applications, and real-time feedback and monitoring through the Virti digital platform. Each intervention module is specifically aligned with a TPB construct:
Module A (Attitude): Uses persuasive VR messages to emphasize benefits of healthy weight control (e.g., appearance, health improvement).
Module B (Subjective Norm): Reinforces perceived social support through peer modeling and family involvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Multi-Modal Digital Intervention Group
Participants in this group will receive a multi-modal digital intervention designed to enhance healthy weight control behaviors among overweight and obese adolescents.
- Intervention Components: The intervention integrates AI-driven coaching, interactive platforms, gamified applications, and real-time feedback mechanisms.
- Session Structure: Participants will complete biweekly intervention sessions (2 hours each) over a 3-month period.
- 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.
- Digital Platform: Participants will have access to the Virti platform, where they will receive personalized guidance and feedback.
干预措施: Multi-Modal Digital Intervention (Behavioral)
Control Group (General Health Education)
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).
干预措施: Multi-Modal Digital Intervention (Behavioral)
结局指标
主要结局
Change in Healthy Weight Control Behaviors as Measured by the Weight Control Behavior (WCB) Scale
时间窗: Baseline (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) Scale
时间窗: Baseline (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.
次要结局
- 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))
- Change in Self-Esteem as Measured by the Multidimensional Body-Self Relations Questionnaire (MBSRQ)(Baseline (T0) and 3 months post-intervention (T2))
- Change in Depression Symptoms as Measured by the Patient Health Questionnaire for Adolescents (PHQ-A)(Baseline (T0) and 3 months post-intervention (T2))
研究者
Pei-Ching Liu
Assistant Professor
National Yang Ming Chiao Tung University