Piloting a Generative Artificial Intelligence Chatbot in a Mobile Weight Loss Program

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT07534254
Status
Recruiting
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Conditions

  • Overweight and/or Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 39 Years
Healthy Volunteers
Accepted

Interventions

  • AGILE Intervention — BEHAVIORAL
    12-week behavioral weight loss intervention that includes daily self-monitoring (tracking) of dietary intake, physical activity, and weight; personalized daily goals for dietary intake and physical activity; weekly behavioral lessons in the study app; weekly tailored feedback on goal progress and weight change; and 1-2 intervention messages per day that are tailored based on current diet, activity, and/or weight progress. Participants receive a Fitbit activity tracker and scale and track their activity and weight in the Fitbit app. Participants use a simplified approach to self-monitoring their dietary intake by tracking 'red' (high calorie) foods in the study's food log smartphone app. This data is used to inform the daily intervention messages and weekly tailored feedback.
  • Chatbot — BEHAVIORAL
    The AGILE chatbot operates via a trained generative artificial intelligence large language model and offers additional support to participants for making changes in their dietary and physical activity behaviors. The chatbot is available for conversation only after a message has been delivered in the AGILE app. Participants can choose to start a conversation or not, and the ability to start a conversation expires at midnight. The chatbot is able to provide evidence-based cognitive behavioral support to participants including, but not limited to: 1) strategies and tips for dietary self-monitoring, physical activity tracking (wearing the Fitbit), and self-weighing; 2) overcoming common barriers to dietary and physical activity goal achievement; 3) general support for remaining engaged in behavior change efforts during the course of the program.

Study Details

The goal of this study is to learn if integrating a chatbot into an existing 12-week smartphone-delivered behavioral weight loss program is feasible and effective for weight loss among young adults. Researchers will compare a standard behavioral weight loss program for young adults that delivers 1-2 brief messages per day (AGILE) to the same program with a chatbot that offers additional behavior change support integrated into the app (AGILE + Chatbot) to determine if the program with the chatbot is feasible, acceptable to participants, and improves program engagement and weight change compared to AGILE alone.

Key Dates

Start date
Mar 23, 2026
Status verified
Apr 2026
Primary completion
Jul 13, 2026
Completion
Jul 20, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Core Intervention
    Participants receive the standard AGILE behavioral weight loss intervention via the study smartphone application.
  • Experimental: Core Intervention with Chatbot
    Participants receive the standard AGILE behavioral weight loss intervention via the study smartphone application plus a chatbot integrated into the app.

Primary Outcome Measure

Program engagement [ Time Frame: up to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27514
Karen Hatley, MPH
[email protected]
919-966-5852
Brooke T Nezami, PhD (PRINCIPAL_INVESTIGATOR)
Carmina Valle, PhD (PRINCIPAL_INVESTIGATOR)
Deborah F Tate, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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