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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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

31

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Zhejiang
      • Yiwu, Zhejiang, Cina, 322000
        • 4th Affiliated Hospital, School of Medicine, Zhejiang University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • JITAI

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participant retention rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in body weight
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Jie Yu, Master, 4th Affiliated Hospital, School of Medicine, Zhejiang University, China

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2026

Completamento primario (Effettivo)

15 maggio 2026

Completamento dello studio (Effettivo)

15 maggio 2026

Date di iscrizione allo studio

Primo inviato

28 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 giugno 2026

Primo Inserito (Effettivo)

6 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • KY-2025-344
  • ChiCTR2600118808 (Identificatore di registro: Chinese Clinical Trial Registry)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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