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

No results posted yet for this study

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07534254 on ClinicalTrials.gov