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NCT Number: NCT06547567

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

11 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qianxi County No. 3 Middle School

Tangshan, Hebei, 064300, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

  • 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.

Treatment and study plan

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

  1. Depressive Symptoms

    Time frame: 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.

  2. Anxiety Symptoms

    Time frame: 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.

  3. Behavior Change Motivation

    Time frame: 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.

  4. Autonomous Motivation

    Time frame: 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.

  5. Physical Activity Level

    Time frame: 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.

  6. Exercise Self-Efficacy

    Time frame: 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.

  7. Stage of Behavior Change

    Time frame: 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.

Secondary outcomes

  1. Emotion Regulation Ability

    Time frame: Baseline (1 week before the intervention), 1 week after the end of the intervention, and 8 weeks after the end of the intervention.

    Emotion regulation ability will be assessed using the Emotion Regulation Questionnaire (ERQ), which measures individuals' habitual use of cognitive reappraisal and expressive suppression strategies.

  2. Psychological Resilience

    Time frame: 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 will be assessed using the 10-item Connor-Davidson Resilience Scale (CD-RISC-10).

  3. Help-Seeking Intention

    Time frame: 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 will be assessed using the adapted version of the General Help-Seeking Questionnaire (GHSQ), which measures participants' intentions to seek help from formal and informal sources for emotional or psychological problems.

  4. Social Support Network

    Time frame: 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 will be assessed using the name generator method to characterize the availability and structure of participants' perceived social support network.

  5. Human-AI Relationship

    Time frame: the very end of the intervention

    Human-AI relationship will be assessed using a study questionnaire measuring participants' perceived relationship with the AI system. This outcome will be assessed only in the AI dialogue intervention group.

  6. Quality of Motivational Interviewing

    Time frame: the very end of the intervention

    The quality of motivational interviewing will be assessed using study questionnaire measuring participants' perceived quality of AI-delivered motivational interviewing. This outcome will be assessed only in the AI dialogue intervention group.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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