NCT07824154

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Oct 2026Mar 2027

First Submitted

Initial submission to the registry

September 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

September 11, 2026

Last Update Submit

September 11, 2026

Conditions

Keywords

Lifestyle InterventionGenerative AIDigital HealthHealth CoachingPreventive HealthHealth EquityCulturally Tailored Intervention

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    Baseline, 6 weeks

Secondary Outcomes (7)

  • Feasibility: Body Mass Index (BMI)

    Baseline, 6 weeks

  • Feasibility: Physical Activity Behaviors

    Baseline, 6 weeks

  • Feasibility: Dietary Behaviors

    Baseline, 6 weeks

  • Feasibility: Behavioral Intention for Diabetes Prevention

    Baseline, 6 weeks

  • Perceived Trustworthiness of the Chatbot

    Baseline, 6 weeks

  • +2 more secondary outcomes

Study Arms (1)

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.

Behavioral: AI-Powered Diabetes Prevention Chatbot

Interventions

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.

AI-Powered Diabetes Prevention Chatbot

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Megha Shah, M.D., M.Sc.

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megha K Shah, M.D., M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 17, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
After study completion

Locations