NCT07534254

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Mar 2026Jul 2026

Study Start

First participant enrolled

March 23, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2026

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Overweight and/or Obesity

Keywords

Behavioral interventionWeight lossmHealth intervention

Outcome Measures

Primary Outcomes (2)

  • Program engagement

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

    up to 12 weeks

  • Chatbot engagement

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

    up to 12 weeks

Secondary Outcomes (3)

  • Acceptability - Perceived usefulness of chatbot

    12 weeks

  • Acceptability - Perceived ease of use of chatbot

    12 weeks

  • Percent weight change

    Baseline, Week 12

Study Arms (2)

Core Intervention

EXPERIMENTAL

Participants receive the standard AGILE behavioral weight loss intervention via the study smartphone application.

Behavioral: AGILE Intervention

Core Intervention with Chatbot

EXPERIMENTAL

Participants receive the standard AGILE behavioral weight loss intervention via the study smartphone application plus a chatbot integrated into the app.

Behavioral: AGILE InterventionBehavioral: Chatbot

Interventions

AGILE InterventionBEHAVIORAL

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.

Core InterventionCore Intervention with Chatbot
ChatbotBEHAVIORAL

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.

Core Intervention with Chatbot

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brooke T Nezami, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke T Nezami, PhD

CONTACT

919-966-5852bnezami@unc.edu

Karen Hatley, MPH

CONTACT

919-966-5852keericks@email.unc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start

March 23, 2026

Primary Completion (Estimated)

July 13, 2026

Study Completion (Estimated)

July 20, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)