Diabetes Prevention AI: Enhancing Prevention Strategies Using Personalized Nutrition and Fitness Coaching for the Next Generation
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Megha K Shah, M.D., M.Sc.
- Numéro de téléphone: 404-778-6944
- E-mail: mkshah@emory.edu
Lieux d'étude
-
-
Georgia
-
Atlanta, Georgia, États-Unis, 30322
- Emory University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility and Acceptability: Task completion rate
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility: Body Mass Index (BMI)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Megha Shah, M.D., M.Sc., Emory University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025P013557
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Délai de partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .