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临床试验/NCT07682571
NCT07682571已完成不适用

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

The Fourth Affiliated Hospital of Zhejiang University School of Medicine1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2026年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
1
主要终点
Participant retention rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Participant retention rate

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)
  • Change in physical activity(Baseline and post-intervention assessment, approximately 31 days)
  • Change in sleep quality(Baseline and post-intervention assessment, approximately 31 days)
  • Change in eating self-efficacy(Baseline and post-intervention assessment, approximately 31 days)
  • Change in health-related quality of life(Baseline and post-intervention assessment, approximately 31 days)

研究者

发起方
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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