Pre DiabetesNCT07824154
Diabetes Prevention AI: Enhancing Prevention Strategies Using Personalized Nutrition and Fitness Coaching for the Next Generation
A study testing AI-Powered Diabetes Prevention Chatbot in people with Pre Diabetes and Type2 Diabetes, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre Diabetes, Type2 Diabetes
- What is being tested?
- AI-Powered Diabetes Prevention Chatbot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Pre Diabetes, Type2 Diabetes
- Being tested
- AI-Powered Diabetes Prevention Chatbot
- Keywords
- Lifestyle Intervention, Generative AI, Digital Health, Health Coaching, Preventive Health, Health Equity, Culturally Tailored Intervention
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Powered Diabetes Prevention ChatbotBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AI-Powered Diabetes Prevention Chatbot | Experimental | 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. Receives: Behavioral: AI-Powered Diabetes Prevention Chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Acceptability: Task completion rate
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.
Measured: Baseline, 6 weeks
Feasibility and Acceptability: Conversation length
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
Measured: Baseline, 6 weeks
Secondary outcomes (7)
Feasibility: Body Mass Index (BMI)
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.
Measured: Baseline, 6 weeks
Feasibility: Physical Activity Behaviors
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.
Measured: Baseline, 6 weeks
Feasibility: Dietary Behaviors
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.
Measured: Baseline, 6 weeks
Feasibility: Behavioral Intention for Diabetes Prevention
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
Measured: Baseline, 6 weeks
Perceived Trustworthiness of the Chatbot
Participant-reported trust in the accuracy, reliability, and credibility of information and recommendations provided by the AI chatbot, assessed through study questionnaires.
Measured: Baseline, 6 weeks
Ease of Use: System Usability Scale (SUS)
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.
Measured: Baseline
NASA Task Load Index (NASA-TLX)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Center for Diabetes Translation Research
- Responsible party
- Principal investigator, Megha Kumudchandra Shah, Emory University
- Investigators
- Megha Shah, M.D., M.Sc., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824154
- Sponsor's protocol ID
- 2025P013557
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes