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Purpose

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 integrated into the app that will offer additional behavior change support (AGILE + Chatbot) to see if the program with the chatbot is feasible, acceptable to participants, and improves program engagement and weight change.

Condition

Eligibility

Eligible Ages
Between 18 Years and 39 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 - willing to attend one study visit at research clinic in Chapel Hill, North Carolina

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) - 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Core Intervention 		Participants receive the standard AGILE behavioral weight loss intervention via the study smartphone application.
  • 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 (until a message is delivered the next day). 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.
Experimental
Core Intervention with Chatbot 		Participants receive the standard AGILE behavioral weight loss intervention via the study smartphone application plus a chatbot integrated into the app.
  • 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 (until a message is delivered the next day). 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.

Recruiting Locations

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
Contact:
Karen Hatley, MPH
919-966-5852
keericks@email.unc.edu

More Details

Status
Recruiting
Sponsor
University of North Carolina, Chapel Hill

Study Contact

Brooke T Nezami, PhD
919-966-5852
bnezami@unc.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.