Effects of Digital Health Interventions on the Physical and Mental Health of Middle School Students
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Depressive Symptoms
研究概览
简要总结
1. Study Population
- Sample Size: 20 classes, about 800-1000 children.
- Randomization: This study will adopt a cluster-randomized controlled intervention design. 20 Classes will be randomly assigned in a 1:1:1:1 ratio to one of four groups: the graphic-text intervention group, the video intervention group, the AI dialogue intervention group, and the control group. The randomization process will be centralized and conducted by personnel not involved in the project.
- Inclusion Criteria (all of the following must be met for inclusion):
Both children/adolescents and their parents are willing to participate and demonstrate good compliance.
Children/adolescents have a weight classified as normal, overweight, or obese. Age range: 11 to 13 years. Informed consent is obtained from both the child and the parent. 4. Exclusion Criteria (meeting any one of the following will result in exclusion):
Clinically diagnosed severe mental illness or psychiatric disorders. Clinically diagnosed eating disorders (e.g., binge eating disorder). Physical developmental abnormalities or disabilities that prevent normal physical activity.
详细描述
Intervention Content Control Group: The students did not receive any additional intervention and continued with their regular school activities. After the intervention, a complete set of video and graphic materials was provided to the control group students to ensure ethical fairness.
Graphic-text Intervention Group: The students read the electronic version of the instruction manual on the computer screen in the computer room for about 10 minutes each week.
Video Intervention Group: Students watch AI-produced videos on the computer screens in the computer room for about 10 minutes each week. The playback progress of the videos is uniformly controlled by the teacher end, and the student end cannot operate it independently.
AI Dialogue Intervention Group: Students conducted text-based conversations with a "health partner" based on a large language model using computers in the computer room, for approximately 10-15 minutes each week. In this group, about half of the students were randomly assigned to the motivational interview dialogue group, while the other half were assigned to the non-motivational interview dialogue group. The content of the conversations (all focusing on topics related to physical activity) and the duration of the conversations were the same for both groups, but the communication methods were different.
Follow-up Survey This study will conduct assessments at baseline (1 week before the intervention), 1 week after the end of the intervention, and 8 weeks after the end of the intervention. Baseline assessment will include all outcome measures, demographic information, and baseline physical activity level. The assessment at 1 week after the intervention will include all outcome measures, process indicators, and satisfaction evaluation (for intervention groups only). The assessment at 8 weeks after the intervention will include all outcome measures and behavioral maintenance. In addition, for the AI dialogue group, an immediate post-test will be conducted after the first dialogue session, and an additional follow-up assessment will be conducted during the mid-intervention period (approximately 1-2 weeks after baseline).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria (all of the following must be met for inclusion):
- •Both children/adolescents and their parents are willing to participate and demonstrate good compliance.
- •Children/adolescents have a weight classified as normal, overweight, or obese. Age range: 11 to 13 years. Informed consent is obtained from both the child and the parent.
排除标准
- •(meeting any one of the following will result in exclusion):
- •Clinically diagnosed severe mental illness or psychiatric disorders. Clinically diagnosed eating disorders (e.g., binge eating disorder). Physical developmental abnormalities or disabilities that prevent normal physical activity.
研究组 & 干预措施
Graphic-text Intervention Group
The students read the electronic version of the instruction manual on the computer screen in the computer room for about 10 minutes each week.
干预措施: Graphic-text Intervention (Other)
Video Intervention Group
Students watch AI-produced videos on the computer screens in the computer room for about 10 minutes each week. The playback progress of the videos is uniformly controlled by the teacher end, and the student end cannot operate it independently.
干预措施: Video Intervention (Other)
AI Dialogue Intervention Group
Students conducted text-based conversations with a "health partner" based on a large language model using computers in the computer room, for approximately 10-15 minutes each week. In this group, about half of the students were randomly assigned to the motivational interview dialogue group, while the other half were assigned to the non-motivational interview dialogue group. The content of the conversations (all focusing on topics related to physical activity) and the duration of the conversations were the same for both groups, but the communication methods were different.
干预措施: AI Dialogue Intervention (Other)
Control Group
The students did not receive any additional intervention and continued with their regular school activities. After the intervention, a complete set of video and graphic materials was provided to the control group students to ensure ethical fairness.
结局指标
主要结局
Depressive Symptoms
时间窗: Baseline (1 week before the intervention), 1 week after the end of the intervention, and 8 weeks after the end of the intervention.
Depressive symptoms will be assessed using the 10-item Center for Epidemiologic Studies Depression Scale (CESD-10), with higher scores indicating more severe depressive symptoms.
Anxiety Symptoms
时间窗: Baseline (1 week before the intervention), 1 week after the end of the intervention, and 8 weeks after the end of the intervention.
Anxiety symptoms will be assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7), with higher scores indicating more severe anxiety symptoms.
Behavior Change Motivation
时间窗: Baseline (1 week before the intervention), the very end of the intervention, and 8 weeks after the end of the intervention.
Behavior change motivation will be assessed using a study questionnaire measuring participants' motivation to initiate and sustain target health behavior change.
Autonomous Motivation
时间窗: Baseline (1 week before the intervention), 1 week after the end of the intervention, 1 month after the end of the intervention, and 8 weeks after the end of the intervention.
Autonomous motivation will be assessed using a study questionnaire to measure the extent to which participants engage in the target behavior for self-endorsed and personally valued reasons.
Physical Activity Level
时间窗: Baseline (1 week before the intervention), 1 week after the end of the intervention, 1 month after the end of the intervention, and 8 weeks after the end of the intervention.
Physical activity level will be assessed using the questionnaire, which captures self-reported physical activity. This outcome will be assessed in the graphic-text intervention and AI dialogue intervention groups and the control group only.
Exercise Self-Efficacy
时间窗: Baseline (1 week before the intervention), 1 week after the end of the intervention, 1 month after the end of the intervention, and 8 weeks after the end of the intervention.
Exercise self-efficacy will be assessed using a study questionnaire measuring participants' confidence in their ability to engage in and maintain physical activity under various circumstances.
Stage of Behavior Change
时间窗: Baseline (1 week before the intervention), 1 month after the end of the intervention, and 8 weeks after the end of the intervention.
Stage of behavior change will be assessed using a study questionnaire, measuring participants' behavior change stages with respect to the target behavior.
次要结局
- Emotion Regulation Ability(Baseline (1 week before the intervention), 1 week after the end of the intervention, and 8 weeks after the end of the intervention.)
- Psychological Resilience(Baseline (1 week before the intervention), 1 week after the end of the intervention, and 8 weeks after the end of the intervention.)
- Help-Seeking Intention(Baseline (1 week before the intervention), 1 week after the end of the intervention, and 8 weeks after the end of the intervention.)
- Social Support Network(Baseline (1 week before the intervention), 1 week after the end of the intervention, and 8 weeks after the end of the intervention.)
- Human-AI Relationship(the very end of the intervention)
- Quality of Motivational Interviewing(the very end of the intervention)
研究者
Zheng Liu
Associate Professor
Peking University