Overweight , ObesityNCT07682571
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
A study testing AI Health Coach-based Just-in-Time Adaptive Intervention in people with Overweight , Obesity, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Overweight , Obesity
- What is being tested?
- AI Health Coach-based Just-in-Time Adaptive Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 15 May 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
4th Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu, Zhejiang, 322000
About this study
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.
Read the 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.
- Conditions
- Overweight , Obesity
- Being tested
- AI Health Coach-based Just-in-Time Adaptive Intervention
- Keywords
- Artificial Intelligence, Just-in-Time Adaptive Intervention, Weight Management, Health Behavior Change
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI Health Coach-based Just-in-Time Adaptive InterventionBehavioural
Also called JITAI
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.
| Study group | Role | What they receive |
|---|---|---|
| AI Health Coach-based JITAI | Experimental | 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. Receives: Behavioral: AI Health Coach-based Just-in-Time Adaptive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant retention rate
Retention rate was defined as the proportion of enrolled participants who completed the post-intervention assessment.
Measured: From enrollment to post-intervention assessment, approximately 31 days
Valid wearable use rate
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.
Measured: During the 31-day intervention period
Active engagement rate
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.
Measured: During the 31-day intervention period
Acceptability of the AI health coach-based intervention
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.
Measured: Post-intervention assessment, approximately 31 days
Secondary outcomes (9)
Change in body weight
Body weight was measured at baseline and post-intervention. The outcome was the change in body weight from baseline to post-intervention.
Measured: Baseline and post-intervention assessment, approximately 31 days
Change in body mass index
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.
Measured: Baseline and post-intervention assessment, approximately 31 days
Change in body fat percentage
Body fat percentage was measured at baseline and post-intervention. The outcome was the change in body fat percentage from baseline to post-intervention.
Measured: Baseline and post-intervention assessment, approximately 31 days
Change in waist circumference
Waist circumference was measured at baseline and post-intervention. The outcome was the change in waist circumference from baseline to post-intervention.
Measured: Baseline and post-intervention assessment, approximately 31 days
Change in visceral fat level
Visceral fat level was measured at baseline and post-intervention. The outcome was the change in visceral fat level from baseline to post-intervention.
Measured: Baseline and post-intervention assessment, approximately 31 days
Change in physical activity
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.
Measured: Baseline and post-intervention assessment, approximately 31 days
Change in sleep quality
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.
Measured: Baseline and post-intervention assessment, approximately 31 days
Change in eating self-efficacy
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.
Measured: Baseline and post-intervention assessment, approximately 31 days
Change in health-related quality of life
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.
Measured: Baseline and post-intervention assessment, approximately 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Mar 2026
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm pilot study in which all participants received an AI health coach-based just-in-time adaptive intervention for weight management.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Yu, Master, Principal investigator, 4th Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682571
- Sponsor's protocol ID
- KY-2025-344
- Other IDs
- ChiCTR2600118808
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and analyzed during the current study are not publicly available because they contain potentially identifiable participant-level behavioral, wearable, and interaction data, but deidentified data may be available from the corresponding author upon reasonable request and with appropriate ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07682571
- Acronym / sponsor ID
- KY-2025-344
- Conditions
- Overweight , Obesity
- Keywords
- Artificial Intelligence, Just-in-Time Adaptive Intervention, Weight Management, Health Behavior Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 6 Jul 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm pilot study in which all participants received an AI health coach-based just-in-time adaptive intervention for weight management.
| Arm | Type | Receives |
|---|---|---|
| AI Health Coach-based JITAI | Experimental | Behavioral: AI Health Coach-based Just-in-Time Adaptive InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| AI Health Coach-based Just-in-Time Adaptive InterventionAlso: JITAIThe 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. | Behavioural | AI Health Coach-based JITAI |
Primary outcome
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.
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.
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.
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.
9 secondary outcomes
Change in body weight
Time frame: Baseline and post-intervention assessment, approximately 31 days
Change in body mass index
Time frame: Baseline and post-intervention assessment, approximately 31 days
Change in body fat percentage
Time frame: Baseline and post-intervention assessment, approximately 31 days
Change in waist circumference
Time frame: Baseline and post-intervention assessment, approximately 31 days
Change in visceral fat level
Time frame: Baseline and post-intervention assessment, approximately 31 days
Change in physical activity
Time frame: Baseline and post-intervention assessment, approximately 31 days
Change in sleep quality
Time frame: Baseline and post-intervention assessment, approximately 31 days
Change in eating self-efficacy
Time frame: 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
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 6 Jul 2026.
- Individual participant dataSharing planned: No. The datasets generated and analyzed during the current study are not publicly available because they contain potentially identifiable participant-level behavioral, wearable, and interaction data, but deidentified data may be available from the corresponding author upon reasonable request and with appropriate ethical approval.
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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.
Jie Yu, Master principal investigator
4th Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI Health Coach-based Just-in-Time Adaptive Intervention in people with Overweight , Obesity, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine 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?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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 6 Jul 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?
Participant retention rate (time frame: From enrollment to post-intervention assessment, approximately 31 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2026.