NCT07682571

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
Last Updated

July 6, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 28, 2026

Last Update Submit

June 28, 2026

Conditions

Overweight , Obesity

Keywords

Artificial IntelligenceJust-in-Time Adaptive InterventionWeight ManagementHealth Behavior Change

Outcome Measures

Primary Outcomes (4)

  • Participant retention rate

    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

    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

    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

    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 Outcomes (9)

  • Change in body weight

    Baseline and post-intervention assessment, approximately 31 days

  • Change in body mass index

    Baseline and post-intervention assessment, approximately 31 days

  • Change in body fat percentage

    Baseline and post-intervention assessment, approximately 31 days

  • Change in waist circumference

    Baseline and post-intervention assessment, approximately 31 days

  • Change in visceral fat level

    Baseline and post-intervention assessment, approximately 31 days

  • +4 more secondary outcomes

Study Arms (1)

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.

Behavioral: AI Health Coach-based Just-in-Time Adaptive Intervention

Interventions

AI Health Coach-based Just-in-Time Adaptive InterventionBEHAVIORAL

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.

Also known as: JITAI
AI Health Coach-based JITAI

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

4th Affiliated Hospital, School of Medicine, Zhejiang University

Yiwu, Zhejiang, 322000, China

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jie Yu, Master

    4th Affiliated Hospital, School of Medicine, Zhejiang University, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-arm pilot study in which all participants received an AI health coach-based just-in-time adaptive intervention for weight management.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2026

First Posted

July 6, 2026

Study Start

March 1, 2026

Primary Completion

May 15, 2026

Study Completion

May 15, 2026

Last Updated

July 6, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations

CN(1)