Piloting a Generative Artificial Intelligence Chatbot in a Mobile Weight Loss Program
NCT07534254 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-04-22
Summary
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.
Conditions
- Overweight and/or Obesity
Interventions
- BEHAVIORAL
-
AGILE Intervention
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.
- BEHAVIORAL
-
Chatbot
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.
Sponsors & Collaborators
-
UNC Gillings School of Global Public Health
collaborator UNKNOWN -
University of North Carolina, Chapel Hill
lead OTHER
Principal Investigators
-
Brooke T Nezami, PhD · University of North Carolina, Chapel Hill
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 39 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-23
- Primary Completion
- 2026-07-13
- Completion
- 2026-07-20
Countries
- United States
Study Locations
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