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Recruiting Not applicable NCT07534254

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

No applicable phase (e.g. observational)
Conditions: Overweight and/or Obesity

Sponsor: University of North Carolina, Chapel Hill

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
AGILE Intervention
BEHAVIORAL
Chatbot
BEHAVIORAL
Locations 1
United States (1)
University of North Carolina at Chapel Hill
Chapel Hill , North Carolina
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
39 Years
Healthy volunteers
No
Start date
23.03.2026
Completion date
20.07.2026
Registry ID
NCT07534254
Source
clinicaltrials.gov
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