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

NCT06547567 | Active Not Recruiting

• 1 other identifier: PU IRB V1 (2023-10-31)
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

1\. Study Population

1. 1.Sample Size: 20 classes, about 800-1000 children.
2. 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. 3.Inclusion Criteria (all of the following must be met for inclusion):
4. 4.Exclusion Criteria (meeting any one of the following will result in exclusion):

Conditions

Pediatric Obesity

Outcome Measures

Primary Outcomes (7)

• Depressive Symptoms

  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.

  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

  Anxiety symptoms will be assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7), with higher scores indicating more severe anxiety symptoms.

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

• Behavior Change Motivation

  Behavior change motivation will be assessed using a study questionnaire measuring participants' motivation to initiate and sustain target health behavior change.

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

• Autonomous Motivation

  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.

  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

  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.

  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

  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.

  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.

• Stage of Behavior Change

  Stage of behavior change will be assessed using a study questionnaire, measuring participants' behavior change stages with respect to the target behavior.

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

Secondary Outcomes (6)

• 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

Study Arms (4)

Graphic-text Intervention Group

EXPERIMENTAL

The students read the electronic version of the instruction manual on the computer screen in the computer room for about 10 minutes each week.

Other: Graphic-text Intervention

Video Intervention Group

EXPERIMENTAL

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.

Other: Video Intervention

AI Dialogue Intervention Group

EXPERIMENTAL

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.

Other: AI Dialogue Intervention

Control Group

NO INTERVENTION

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.

Interventions

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.

Graphic-text Intervention Group

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.

Video Intervention Group

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.

AI Dialogue Intervention Group

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Qianxi County No. 3 Middle School

Tangshan, Hebei, 064300, China

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 9, 2024
• Study Start: May 12, 2026
• Primary Completion: July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

CN (1)