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Diabetes Prevention AI: Enhancing Prevention Strategies Using Personalized Nutrition and Fitness Coaching for the Next Generation

11 settembre 2026 aggiornato da: Megha Kumudchandra Shah, Emory University

This study is testing an artificial intelligence (AI) chatbot designed to help adults at risk for type 2 diabetes adopt healthier lifestyles. The chatbot provides personalized and culturally tailored guidance on nutrition, physical activity, resistance training, and goal setting. About 30 adults aged 18 to 55 years will use the chatbot for 6 weeks and provide feedback through surveys and interviews.

Researchers will evaluate whether the chatbot is easy to use, helpful, and trustworthy, and whether data about changes in health behaviors can be feasibly collected, in order to inform larger future studies to improve diabetes prevention.

Panoramica dello studio

Stato

Non ancora reclutamento

Descrizione dettagliata

Type 2 diabetes continues to be a major public health concern, with growing evidence that individuals with normal body weight may also be at increased risk of developing prediabetes and type 2 diabetes. Existing diabetes prevention programs have primarily targeted individuals with overweight or obesity, creating a need for innovative prevention approaches tailored to younger, normal-weight, and culturally diverse populations.

This study will evaluate a novel artificial intelligence (AI)-powered chatbot designed to deliver personalized, culturally tailored diabetes prevention support. The intervention combines evidence-based nutrition and physical activity guidance with conversational AI technology to provide accessible lifestyle coaching focused on diabetes risk reduction. The chatbot incorporates expert-validated educational content and behavioral support strategies intended to promote healthy habits and sustained engagement.

The chatbot was developed using a curated knowledge base of culturally adapted diabetes prevention recommendations. Personalized guidance is generated using participant preferences, context, and validated educational resources to support lifestyle behaviors associated with improved metabolic health. The platform is intended to provide scalable, user-centered support while maintaining alignment with established diabetes prevention principles.

This pilot study will assess the feasibility and acceptability of implementing an AI-enabled diabetes prevention intervention in a real-world setting. Researchers will evaluate user experiences with the chatbot, including engagement, satisfaction, trust, usability, and perceptions of cultural relevance. Findings will inform future development of digital health interventions and support the design of larger studies aimed at evaluating the effectiveness of AI-assisted approaches for diabetes prevention and health equity.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

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.

Contatto studio

  • Nome: Megha K Shah, M.D., M.Sc.
  • Numero di telefono: 404-778-6944
  • Email: mkshah@emory.edu

Luoghi di studio

    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Emory 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

Sì

Descrizione

Inclusion Criteria:

  • Have at least one of the following diabetes risk factors:

    • HbA1C of 5.7-6.4%
    • BMI of 18.5 - 24.9 kg/m^2
    • Fasting plasma glucose 100 - 125 mg/dL
    • Family history of type 2 diabetes in first-degree relatives (parents, siblings, or children)
    • History of gestational diabetes
    • Membership in a high-risk ethnic group (African American, Hispanic, Native American, Asian American, Pacific Islander)
  • Access to a smartphone or computer with internet
  • English reading and writing proficiency
  • Be willing to use the chatbot at least 3 times per week
  • Be able to provide informed consent
  • Availability for the 6-week study duration
  • Able to perform resistance training exercises

Exclusion Criteria:

  • Are diagnosed with type 1 or type 2 diabetics
  • Have uncontrolled hypertension (higher than 160/100 mmHg)
  • Have cardiovascular disease
  • Are pregnant or planning to be pregnant
  • Are actively undergoing treatment for cancer
  • Have an eating disorder
  • Have chronic kidney disease
  • Are enrolled in another research study or participating in a structured lifestyle program

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

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: AI-Powered Diabetes Prevention Chatbot
Participants will receive access to an artificial intelligence (AI)-powered chatbot that provides personalized, culturally tailored diabetes prevention guidance focused on nutrition, resistance training, goal setting, and lifestyle behavior change for a 6-week intervention period.
Participants will use a generative AI chatbot designed to provide personalized, evidence-based diabetes prevention support. The chatbot delivers culturally tailored nutrition and physical activity recommendations, with an emphasis on high-protein dietary strategies, resistance training, goal setting, motivational support, and healthy lifestyle behaviors. Participants will be encouraged to interact with the chatbot at least three times per week during the 6-week study period. Recommendations are generated using expert-validated diabetes prevention content and personalized according to participant characteristics and preferences.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility and Acceptability: Task completion rate
Lasso di tempo: Baseline, 6 weeks
The proportion of recommended chatbot activities, goals, or behavioral tasks completed by participants during the 6-week intervention period, as assessed through chatbot analytics. This measure will be used to evaluate participant engagement and adherence to chatbot-delivered recommendations.
Baseline, 6 weeks
Feasibility and Acceptability: Conversation length
Lasso di tempo: Baseline, 6 weeks
Average number of messages exchanged between participants and the AI chatbot during each interaction session over the study period. Conversation length will be obtained from chatbot analytics and used as an indicator of participant engagement with the intervention. Longer conversations may reflect greater interaction with chatbot-delivered nutrition, physical activity, and lifestyle coaching content
Baseline, 6 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility: Body Mass Index (BMI)
Lasso di tempo: Baseline, 6 weeks
Proportion of participants for whom self-reported body mass index (BMI, kg/m²) is successfully collected at baseline and at the end of the 6-week intervention period. BMI will be calculated using participant-reported height and weight collected through study surveys.
Baseline, 6 weeks
Feasibility: Physical Activity Behaviors
Lasso di tempo: Baseline, 6 weeks
Proportion of participants for whom self-reported physical activity behaviors, including engagement in resistance training and overall activity levels, will be successfully collected through study questionnaires and chatbot interaction data.
Baseline, 6 weeks
Feasibility: Dietary Behaviors
Lasso di tempo: Baseline, 6 weeks
Proportion of participants for whom self-reported dietary intake and nutrition-related behaviors, including the adoption of higher-protein dietary practices and other healthy eating behaviors promoted by the chatbot intervention, are successfully collected. Data will be collected through participant surveys and chatbot interaction records.
Baseline, 6 weeks
Feasibility: Behavioral Intention for Diabetes Prevention
Lasso di tempo: Baseline, 6 weeks
Proportion of participants with successfully recorded self-reported intention and readiness to engage in healthy lifestyle behaviors for diabetes prevention, including dietary modifications and physical activity, as assessed through study questionnaires
Baseline, 6 weeks
Perceived Trustworthiness of the Chatbot
Lasso di tempo: Baseline, 6 weeks
Participant-reported trust in the accuracy, reliability, and credibility of information and recommendations provided by the AI chatbot, assessed through study questionnaires.
Baseline, 6 weeks
Ease of Use: System Usability Scale (SUS)
Lasso di tempo: Baseline
The SUS is a 10-item questionnaire that assesses participants' perceived usability of the application. Each item is rated on a 5-point response scale. Responses are scored using the standard SUS scoring method to generate a total score ranging from 0 to 100, with higher scores indicating greater perceived usability.
Baseline
NASA Task Load Index (NASA-TLX)
Lasso di tempo: Baseline
The NASA-TLX assesses participants' perceived cognitive workload while using the application across six domains: mental demand, physical demand, temporal demand, perceived performance, effort, and frustration. An overall workload score will be calculated from the domain ratings. Scores range from 0 to 100, with higher scores indicating greater perceived workload or task demand.
Baseline

Collaboratori e investigatori

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

Investigatori

  • Investigatore principale: Megha Shah, M.D., M.Sc., Emory University

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 (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

11 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 settembre 2026

Primo Inserito (Effettivo)

17 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

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

SÌ

Periodo di condivisione IPD

After study completion

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO

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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