Clinical trial

Effects of Digital Health Interventions on the Physical and Mental Health of Middle School Students

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06547567

Active, not recruitingNot applicableInterventional

What this study is about

1\. Study Population 1. Sample Size: 20 classes, about 800-1000 children. 2. 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. 3. 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.

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

Age11 Years to 13 Years

SexAll

Healthy volunteersAccepted

ConditionPediatric Obesity

Full registry criteria

1. 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. 2. 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.

Treatments and study arms

Graphic-text Intervention

Other

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

Other

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

Other

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.

Primary outcomes

Depressive SymptomsBaseline (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 SymptomsBaseline (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 MotivationBaseline (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 MotivationBaseline (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 LevelBaseline (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-EfficacyBaseline (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 ChangeBaseline (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.

Study locations

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Qianxi County No. 3 Middle School🇨🇳 Tangshan, Hebei, China

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