Pediatric Obesity
Conditions
Brief 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. 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.
Interventions
OTHERMI chatbot Intervention
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.
OTHERGeneral-counseling chatbot intervention
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.
OTHERGraphic-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.
OTHERVideo 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.
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
Participants in the chatbot arm were blinded; however, participant blinding was not feasible for the graphic-text and video intervention arms owing to the nature of these interventions.
Eligibility
Sex/Gender
ALL
Age
11 Years to 13 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | 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 | 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. |
| Behavior Change Motivation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived empathy | Immediately after the intervention (approximately 30 minutes after baseline) | 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. |
| Student-Rated Satisfaction | Immediately after the intervention (approximately 30 minutes after baseline) | 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. |
| Usability | Immediately after the intervention (approximately 30 minutes after baseline) | 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. |
| Motivational interviewing fidelity | Immediately after the intervention (approximately 30 minutes after baseline) | 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. |
| Emotion regulation ability | Baseline, 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. |
| Psychological resilience | Baseline, 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). |
| Social support network | Baseline, 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. |
| Help-seeking intention | Baseline, 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. |
| Working alliance | Immediately after the intervention (approximately 30 minutes after baseline) | 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. |
Countries
China
Outcome results
None listed