Pediatric ObesityNCT06547567
Effects of Digital Health Interventions on the Motivation, Health-related Behavior and Mental Health of Middle School Students
A study testing MI chatbot Intervention, General-counseling chatbot intervention and Graphic-text intervention in people with Pediatric Obesity, run by Peking University at 1 site in China.
Trial summary
The goal of this cluster-randomized clinical trial is to learn whether digital interventions, especially a motivational interviewing (MI) chatbot can improve adolescents' physical activity motivation and behavior, as well as support their mental health. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- MI chatbot Intervention, General-counseling chatbot intervention and Graphic-text intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 705 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2026to 22 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Digital Health Interventions on the Motivation, Health-related Behavior and Mantal Health of Middle School Students
The goal of this cluster-randomized clinical trial is to learn whether digital interventions, especially a motivational interviewing (MI) chatbot can improve adolescents' physical activity motivation and behavior, as well as support their mental health. The main questions it aims to answer are:
- Does the MI chatbot improve how important participants consider physical activity, their confidence in becoming more active, and their readiness to do so?
- Does the digital interventions improve their mental health?
Read more
Researchers will compare the chatbot, text and video intervention groups with a blank control group. Particularly, an MI chatbot will be compared with a general-counseling chatbot. School classes will be randomly assigned to one of the arms.
Participants will:
- Complete baseline questionnaires about their characteristics, physical activity, and motivation.
- Have a conversation about physical activity with their assigned chatbot, or watch a graphic-text poster, or a video.
- Complete a post-test questionnaires after the intervention.
Read the detailed description
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, the very end of the intervention, 1 week after the end of the intervention, and 8 weeks after the end of the intervention.
- Conditions
- Pediatric Obesity
- Being tested
- MI chatbot Intervention, General-counseling chatbot intervention, Graphic-text intervention, Video intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI chatbot InterventionOther
Students conducted text-based conversations with a "health partner" MI chatbot based on a large language model using computers in the computer room, for approximately 10-15 minutes. The MI chatbot were designed using MI-consistent prompt.
General-counseling chatbot interventionOther
Students conducted text-based conversations with a "health partner" chatbot based on a large language model using computers in the computer room, for approximately 10-15 minutes. The General-counseling chatbot were designed using basic prompt without MI-consistent instrcutions.
Graphic-text interventionOther
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 interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| MI chatbot Intervention Group | Experimental | Students conducted text-based conversations with a "health partner" MI chatbot based on a large language model using computers in the computer room, for approximately 10-15 minutes. The MI chatbot were designed using MI-consistent prompt. Receives: Other: MI chatbot Intervention |
| General-counseling chatbot intervention group | Active comparator | Students conducted text-based conversations with a "health partner" chatbot based on a large language model using computers in the computer room, for approximately 10-15 minutes. The General-counseling chatbot were designed using basic prompt without MI-consistent instrcutions. Receives: Other: General-counseling chatbot intervention |
| 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. Receives: 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. Receives: Other: Video 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Change Motivation
Behavior change motivation will be assessed using a study questionnaire measuring participants' motivation to initiate and sustain target health behavior change.
Measured: Baseline, Immediately after the intervention (approximately 30 minutes after baseline)
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.
Measured: Baseline, 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.
Measured: Baseline, 1 week after the end of the intervention, and 8 weeks after the end of the intervention.
Secondary outcomes (9)
Working alliance
Working alliance will be assessed using Working Alliance Inventory-Short Revised (WAI-SR) measuring participants' perceived relationship with the AI system. This outcome will be assessed only in the AI dialogue intervention group.
Measured: Immediately after the intervention (approximately 30 minutes after baseline)
Perceived empathy
Perceived empathy will be assessed using Consultation and Relational Empathy Measure (CARE) measuring participants' perceived empathy from AI-delivered motivational interviewing. This outcome will be assessed only in the AI dialogue intervention group.
Measured: Immediately after the intervention (approximately 30 minutes after baseline)
Student-Rated Satisfaction
Student-rated satisfaction will be assessed using study questionnaire measuring students' satisfaction for the AI-delivered counseling. This outcome will be assessed only in the AI dialogue intervention group.
Measured: Immediately after the intervention (approximately 30 minutes after baseline)
Usability
Usability will be assessed using Chatbot Usability Questionnaire (CUQ) measuring participants' perceived usability the AI-delivered motivational interviewing. This outcome will be assessed only in the AI dialogue intervention group.
Measured: Immediately after the intervention (approximately 30 minutes after baseline)
Motivational interviewing fidelity
Motivational interviewing fidelity will be measured by analyzing the transcripts of AI-delivered Motivational interviewing sessions using MITI or MISC codebooks. These outcomes will be assessed only in the AI dialogue intervention group.
Measured: Immediately after the intervention (approximately 30 minutes after baseline)
Emotion regulation ability
Emotion regulation ability will be assessed using the Emotion Regulation Questionnaire (ERQ), which measures individuals' habitual use of cognitive reappraisal and expressive suppression strategies.
Measured: Baseline, 1 week after the end of the intervention, and 8 weeks after the end of the intervention.
Psychological resilience
Psychological resilience will be assessed using the 10-item Connor-Davidson Resilience Scale (CD-RISC-10).
Measured: Baseline, 1 week after the end of the intervention, and 8 weeks after the end of the intervention.
Social support network
Social support network will be assessed using the name generator method to characterize the availability and structure of participants' perceived social support network.
Measured: Baseline, 1 week after the end of the intervention, and 8 weeks after the end of the intervention.
Help-seeking intention
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.
Measured: Baseline, 1 week after the end of the intervention, and 8 weeks after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start12 May 2026
- Primary completion12 May 2026
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Liu, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547567
- Sponsor's protocol ID
- PU IRB V1 (2023-10-31)
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kong JQ, Chen J, Yang Y, Yang YH, Liu JY, Hu RZ, Li JY, Zhang XR, Liu Z. Effect of autonomous motivation support on obesity prevention in early adolescents: a study protocol of cluster-randomized controlled trial based on the integrated SDT-TPB framework. Trials. 2026 Jun 11. doi: 10.1186/s13063-026-09824-y. Online ahead of print.
PubMed 42277851
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Digital Health Interventions on the Motivation, Health-related Behavior and Mantal Health of Middle School Students
- ClinicalTrials.gov ID
- NCT06547567
- Acronym / sponsor ID
- PU IRB V1 (2023-10-31)
- Conditions
- Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this cluster-randomized clinical trial is to learn whether digital interventions, especially a motivational interviewing (MI) chatbot can improve adolescents' physical activity motivation and behavior, as well as support their mental health. The main questions it aims to answer are:
- Does the MI chatbot improve how important participants consider physical activity, their confidence in becoming more active, and their readiness to do so?
- Does the digital interventions improve their mental health?
Researchers will compare the chatbot, text and video intervention groups with a blank control group. Particularly, an MI chatbot will be compared with a general-counseling chatbot. School classes will be randomly assigned to one of the arms.
Participants will:
- Complete baseline questionnaires about their characteristics, physical activity, and motivation.
- Have a conversation about physical activity with their assigned chatbot, or watch a graphic-text poster, or a video.
- Complete a post-test questionnaires after the intervention.
Detailed description
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, the very end of the intervention, 1 week after the end of the intervention, and 8 weeks after the end of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MI chatbot Intervention Group | Experimental | Other: MI chatbot InterventionStudents conducted text-based conversations with a "health partner" MI chatbot based on a large language model using computers in the computer room, for approximately 10-15 minutes. The MI chatbot were designed using MI-consistent prompt. |
| General-counseling chatbot intervention group | Active comparator | Other: General-counseling chatbot interventionStudents conducted text-based conversations with a "health partner" chatbot based on a large language model using computers in the computer room, for approximately 10-15 minutes. The General-counseling chatbot were designed using basic prompt without MI-consistent instrcutions. |
| Graphic-text Intervention Group | Experimental | Other: Graphic-text interventionThe 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 | Experimental | Other: Video interventionStudents 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. |
| 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. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI chatbot InterventionStudents conducted text-based conversations with a "health partner" MI chatbot based on a large language model using computers in the computer room, for approximately 10-15 minutes. The MI chatbot were designed using MI-consistent prompt. | Other | MI chatbot Intervention Group |
| General-counseling chatbot interventionStudents conducted text-based conversations with a "health partner" chatbot based on a large language model using computers in the computer room, for approximately 10-15 minutes. The General-counseling chatbot were designed using basic prompt without MI-consistent instrcutions. | Other | General-counseling chatbot intervention group |
| Graphic-text interventionThe 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 Group |
| Video interventionStudents 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 Group |
Primary outcome
Behavior Change Motivation
Time frame: Baseline, Immediately after the intervention (approximately 30 minutes after baseline)
Behavior change motivation will be assessed using a study questionnaire measuring participants' motivation to initiate and sustain target health behavior change.
Depressive symptoms
Time frame: Baseline, 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
Time frame: Baseline, 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.
9 secondary outcomes
Working alliance
Time frame: Immediately after the intervention (approximately 30 minutes after baseline)
Perceived empathy
Time frame: Immediately after the intervention (approximately 30 minutes after baseline)
Student-Rated Satisfaction
Time frame: Immediately after the intervention (approximately 30 minutes after baseline)
Usability
Time frame: Immediately after the intervention (approximately 30 minutes after baseline)
Motivational interviewing fidelity
Time frame: Immediately after the intervention (approximately 30 minutes after baseline)
Emotion regulation ability
Time frame: Baseline, 1 week after the end of the intervention, and 8 weeks after the end of the intervention.
Psychological resilience
Time frame: Baseline, 1 week after the end of the intervention, and 8 weeks after the end of the intervention.
Social support network
Time frame: Baseline, 1 week after the end of the intervention, and 8 weeks after the end of the intervention.
Help-seeking intention
Time frame: Baseline, 1 week after the end of the intervention, and 8 weeks after the end of the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 42277851Kong JQ, Chen J, Yang Y, Yang YH, Liu JY, Hu RZ, Li JY, Zhang XR, Liu Z. Effect of autonomous motivation support on obesity prevention in early adolescents: a study protocol of cluster-randomized controlled trial based on the integrated SDT-TPB framework. Trials. 2026 Jun 11. doi: 10.1186/s13063-026-09824-y. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI chatbot Intervention, General-counseling chatbot intervention and Graphic-text intervention in people with Pediatric Obesity, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior Change Motivation (time frame: Baseline, Immediately after the intervention (approximately 30 minutes after baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06547567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.