NCT07534254

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

Leveraging Generative Artificial Intelligence in Mobile Health Promotion Programs: A Use Case for Enhancing Tailored Messaging and Engagement in a Mobile Healthy Weight Program

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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 integrated into the app that will offer additional behavior change support (AGILE + Chatbot) to see if the program with the chatbot is feasible, acceptable to participants, and improves program engagement and weight change.

Detailed description

At baseline, 20 young adults, ages 18-39, with overweight or obesity, will be randomized to either the AGILE or AGILE + Chatbot group. Participants in both groups will receive a 12-week mobile behavioral weight loss intervention (AGILE) delivered via the study smartphone application. The weight loss intervention includes weekly evidence-based lessons; personalized goals; self-monitoring of diet, activity, and weight; weekly tailored feedback on progress; and brief, tailored messages 1-2 times per day displayed in the study smartphone app. Participants in the AGILE group will receive no additional program features. Participants in the AGILE + Chatbot group will have a version of the smartphone app with an integrated chatbot. The chatbot will be available for brief conversations 1-2 times per day. Assessments will occur at baseline and 12 weeks.

Conditions

• Overweight and/or Obesity

Interventions

Type	Name	Description
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 (until a message is delivered the next day). 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.

Timeline

• Start date: 2026-03-23
• Primary completion: 2026-07-13
• Completion: 2026-07-20
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States