Leveraging Generative Artificial Intelligence in Mobile Health Promotion Programs: A Use Case for Enhancing Tailored Messaging and Engagement in a Mobile Healthy Weight Program
Trial ID: NCT07534254
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-03-23
Completion date: 2026-07-20
Sponsor: University of North Carolina, Chapel Hill
Collaborators: UNC Gillings School of Global Public Health
Conditions: Overweight and/or Obesity
Interventions: AGILE Intervention; Chatbot
Locations: University of North Carolina at Chapel Hill
Countries: United States
Enrollment: 20
Age range: 18 Years - 39 Years
Sex: ALL

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.

Eligibility criteria:
Inclusion Criteria:

* body mass index (BMI) of 25-45 kg/m\^2
* English-speaking and writing
* own an iPhone with a data plan
* willing to be randomized to either treatment group

Exclusion Criteria:

* Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
* Other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including tuberculosis, currently receiving cancer treatment, or history of a heart attack or stroke
* Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q; items 1-4), or report any other reason not able to walk for physical activity
* Lost 10 or more pounds (and kept it off) in the last 6 months
* Currently taking weight loss medications
* History of weight loss surgery or planning weight loss surgery in the next 4 months
* Report a past diagnosis of, or receiving treatment for, a DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) eating disorder (anorexia nervosa or bulimia nervosa)
* Currently pregnant or planning to become pregnant within the next 4 months
* Health or psychological diagnoses that preclude participation in a prescribed dietary and exercise program, including history of or diagnosis of schizophrenia or bipolar disorder, hospitalization for a psychiatric diagnosis in the past year, current diagnosis of alcohol or substance abuse
* Another member of the household is a participant or staff member on this trial
* Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study
* Not willing to wear a Fitbit every day
* Have participated in another study conducted by the UNC Weight Research Program within the past 12 months

Outcomes:
Program engagement; Chatbot engagement