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

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Enrolling

Conditions

Overweight and/or Obesity

Treatments

Behavioral: Chatbot
Behavioral: AGILE Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT07534254
25-1638

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 39 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Core Intervention
Experimental group
Description:
Participants receive the standard AGILE behavioral weight loss intervention via the study smartphone application.
Treatment:
Behavioral: AGILE Intervention
Core Intervention with Chatbot
Experimental group
Description:
Participants receive the standard AGILE behavioral weight loss intervention via the study smartphone application plus a chatbot integrated into the app.
Treatment:
Behavioral: AGILE Intervention
Behavioral: Chatbot

Trial contacts and locations

1

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Central trial contact

Brooke T Nezami, PhD; Karen Hatley, MPH

Data sourced from clinicaltrials.gov

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