- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07682571
Research on the Needs, Feasibility, and Intervention Effects of AI Health Coach-based Just-in-Time Adaptive Intervention (JITAI) in Weight Management for Overweight/Obese Adults
This pilot study evaluates the needs, feasibility, and preliminary effects of an artificial intelligence (AI) health coach-based just-in-time adaptive intervention for weight management in adults with overweight or obesity.
Participants receive a wearable device and use a WeChat-based platform during the intervention period. The system collects wearable data and self-reported information, and provides timely behavior-change support related to physical activity, sedentary behavior, sleep, diet self-monitoring, and weight-management self-regulation. The AI health coach provides conversational support and personalized suggestions based on predefined intervention rules and participant inputs.
The main purpose of this study is to assess whether this AI-supported intervention is feasible and acceptable for adults with overweight or obesity. The study also explores changes in weight-related outcomes, health behaviors, self-efficacy, sleep, and quality of life before and after the intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Overweight and obesity are common chronic health problems that require sustained support for daily behavior change. Digital health interventions may help extend weight-management support into everyday life, but many existing programs rely on generic education, retrospective feedback, or burdensome manual self-monitoring. This study evaluates an AI health coach-based just-in-time adaptive intervention designed to provide timely and individualized support for weight-management behaviors.
This is a single-arm pilot study conducted among adults with overweight or obesity. Participants use a wearable device and a WeChat-based intervention platform during the study period. The intervention combines passive wearable sensing, participant-reported dietary self-monitoring, rule-based just-in-time intervention triggers, and an AI conversational health coach. Intervention content focuses on physical activity, sedentary behavior, sleep-related routines, dietary self-monitoring, and self-regulation for weight management.
The AI health coach provides conversational guidance, encouragement, and behavior-change suggestions. Intervention messages are generated or selected based on participant data and predefined rules, with the goal of delivering support at moments when participants may benefit from timely prompts or feedback.
The study evaluates feasibility and acceptability indicators, including wearable use, participant engagement, dietary self-monitoring, and interaction with the AI health coach. Preliminary intervention effects are explored by comparing baseline and post-intervention measures, including weight-related outcomes, body composition, physical activity, sleep, eating-related self-efficacy, and quality of life. The findings will inform the refinement of AI-supported just-in-time adaptive interventions for future controlled trials in weight management.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zhejiang
-
Yiwu, Zhejiang, China, 322000
- 4th Affiliated Hospital, School of Medicine, Zhejiang University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 to 60 years.
- Body mass index of 24 kg/m2 or higher, meeting the Chinese criteria for overweight or obesity.
- Able to use a smartphone, WeChat-based platform, and wearable device during the study period.
- Willing to participate in the AI health coach-based just-in-time adaptive intervention and complete study assessments.
- Provided written informed consent.
Exclusion Criteria:
- Pregnancy, lactation, or planning pregnancy during the study period.
- Severe cardiovascular, cerebrovascular, hepatic, renal, endocrine, psychiatric, or other major diseases that may affect study participation or safety.
- Medical conditions or medications that may substantially affect body weight or body composition.
- Contraindications to physical activity or inability to complete the intervention procedures.
- Current participation in another weight-management intervention or clinical study.
- Inability to understand the study procedures or complete the required assessments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI Health Coach-based JITAI
Participants received an AI health coach-based just-in-time adaptive intervention for weight management.
The intervention was delivered through a WeChat-based platform and supported by wearable device data and participant-reported dietary self-monitoring.
|
The intervention provided timely behavior-change support for weight management through an AI health coach delivered via a WeChat-based platform.
The system used wearable device data and participant inputs to support physical activity, sedentary behavior reduction, sleep-related routines, dietary self-monitoring, and self-regulation.
Participants received conversational guidance, encouragement, and personalized suggestions based on predefined intervention rules and participant data.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant retention rate
Time Frame: From enrollment to post-intervention assessment, approximately 31 days
|
Retention rate was defined as the proportion of enrolled participants who completed the post-intervention assessment.
|
From enrollment to post-intervention assessment, approximately 31 days
|
|
Valid wearable use rate
Time Frame: During the 31-day intervention period
|
Valid wearable use rate was defined as the proportion of intervention days with valid wearable data.
A valid wearable day was defined as a day with at least 10 hours of wear time or at least 180 minutes of main sleep data.
|
During the 31-day intervention period
|
|
Active engagement rate
Time Frame: During the 31-day intervention period
|
Active engagement rate was defined as the proportion of intervention days on which participants had at least one interaction with the AI health coach or at least one dietary self-monitoring record.
|
During the 31-day intervention period
|
|
Acceptability of the AI health coach-based intervention
Time Frame: Post-intervention assessment, approximately 31 days
|
Acceptability was assessed using a post-intervention questionnaire evaluating participants' perceived usefulness, satisfaction, and willingness to continue using the AI health coach-based intervention.
Higher scores indicate greater acceptability.
|
Post-intervention assessment, approximately 31 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in body weight
Time Frame: Baseline and post-intervention assessment, approximately 31 days
|
Body weight was measured at baseline and post-intervention.
The outcome was the change in body weight from baseline to post-intervention.
|
Baseline and post-intervention assessment, approximately 31 days
|
|
Change in body mass index
Time Frame: Baseline and post-intervention assessment, approximately 31 days
|
Body mass index was calculated from measured body weight and height.
The outcome was the change in body mass index from baseline to post-intervention.
|
Baseline and post-intervention assessment, approximately 31 days
|
|
Change in body fat percentage
Time Frame: Baseline and post-intervention assessment, approximately 31 days
|
Body fat percentage was measured at baseline and post-intervention.
The outcome was the change in body fat percentage from baseline to post-intervention.
|
Baseline and post-intervention assessment, approximately 31 days
|
|
Change in waist circumference
Time Frame: Baseline and post-intervention assessment, approximately 31 days
|
Waist circumference was measured at baseline and post-intervention.
The outcome was the change in waist circumference from baseline to post-intervention.
|
Baseline and post-intervention assessment, approximately 31 days
|
|
Change in visceral fat level
Time Frame: Baseline and post-intervention assessment, approximately 31 days
|
Visceral fat level was measured at baseline and post-intervention.
The outcome was the change in visceral fat level from baseline to post-intervention.
|
Baseline and post-intervention assessment, approximately 31 days
|
|
Change in physical activity
Time Frame: Baseline and post-intervention assessment, approximately 31 days
|
Physical activity was assessed using the International Physical Activity Questionnaire-Short Form.
The outcome was the change in physical activity from baseline to post-intervention.
|
Baseline and post-intervention assessment, approximately 31 days
|
|
Change in sleep quality
Time Frame: Baseline and post-intervention assessment, approximately 31 days
|
Sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index.
The outcome was the change in sleep quality score from baseline to post-intervention.
|
Baseline and post-intervention assessment, approximately 31 days
|
|
Change in eating self-efficacy
Time Frame: Baseline and post-intervention assessment, approximately 31 days
|
Eating self-efficacy was assessed using the Chinese version of the Weight Efficacy Lifestyle Questionnaire-Short Form.
The outcome was the change in eating self-efficacy score from baseline to post-intervention.
|
Baseline and post-intervention assessment, approximately 31 days
|
|
Change in health-related quality of life
Time Frame: Baseline and post-intervention assessment, approximately 31 days
|
Health-related quality of life was assessed using the EQ-5D-5L.
The outcome was the change in health-related quality of life from baseline to post-intervention.
|
Baseline and post-intervention assessment, approximately 31 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jie Yu, Master, 4th Affiliated Hospital, School of Medicine, Zhejiang University, China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY-2025-344
- ChiCTR2600118808 (Registry Identifier: Chinese Clinical Trial Registry)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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