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

NCT06547567 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-04-29

No results posted yet for this study

Summary

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.

Conditions

  • Pediatric Obesity

Interventions

OTHER

Graphic-text Intervention

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

Video Intervention

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

AI Dialogue Intervention

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.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2026-07-31
Completion
2027-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06547567 on ClinicalTrials.gov