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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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

31

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Ostatní jména:
  • JITAI

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Participant retention rate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in body weight
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. března 2026

Primární dokončení (Aktuální)

15. května 2026

Dokončení studie (Aktuální)

15. května 2026

Termíny zápisu do studia

První předloženo

28. června 2026

První předloženo, které splnilo kritéria kontroly kvality

28. června 2026

První zveřejněno (Aktuální)

6. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

28. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • KY-2025-344
  • ChiCTR2600118808 (Identifikátor registru: Chinese Clinical Trial Registry)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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