Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07534254

Active, not recruitingNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 39 Years

SexAll

Healthy volunteersAccepted

ConditionOverweight and/or Obesity

Full registry 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

Treatments and study arms

AGILE Intervention

Behavioral

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.

Chatbot

Behavioral

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.

Primary outcomes

Program engagementup to 12 weeks

Program engagement is defined as the mean percent of days in which participants accessed the AGILE app.

Chatbot engagementup to 12 weeks

Chatbot engagement is defined as the mean percent of days in which participants started a conversation with the chatbot.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of North Carolina at Chapel Hill🇺🇸 Chapel Hill, North Carolina, United States

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