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Overweight and/or ObesityNCT07534254

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

A study testing AGILE Intervention and Chatbot in people with Overweight and/or Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Overweight and/or Obesity
What is being tested?
AGILE Intervention and Chatbot
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
23 Mar 2026to 28 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

Official title: Leveraging Generative Artificial Intelligence in Mobile Health Promotion Programs: A Use Case for Enhancing Tailored Messaging and Engagement in a Mobile Healthy Weight Program

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.

Read the 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.

Being tested
AGILE Intervention, Chatbot
Keywords
Behavioral intervention, Weight loss, mHealth intervention
Medical subject headings
Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGILE InterventionBehavioural

    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.

  • ChatbotBehavioural

    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.

Study groups in NCT07534254
Study groupRoleWhat they receive
Core InterventionExperimentalParticipants receive the standard AGILE behavioral weight loss intervention via the study smartphone application.
Receives: Behavioral: AGILE Intervention
Core Intervention with ChatbotExperimentalParticipants receive the standard AGILE behavioral weight loss intervention via the study smartphone application plus a chatbot integrated into the app.
Receives: Behavioral: AGILE Intervention; Behavioral: Chatbot

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Program engagement

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

    Measured: up to 12 weeks

  2. Chatbot engagement

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

    Measured: up to 12 weeks

Secondary outcomes (3)

  1. Acceptability - Perceived usefulness of chatbot

    Perceived usefulness (PU) of the chatbot is measured by the Perceived Usefulness subscale of the Technology Acceptance Model Questionnaire. This subscale includes four items that assess usefulness of the chatbot within the AGILE program that are scored on a Likert scale of 1 = Strongly disagree to 7 = Strongly agree. A composite score is calculated by taking an average of the four items. Higher values on the composite PU score represent a greater perceived usefulness of the chatbot.

    Measured: 12 weeks

  2. Acceptability - Perceived ease of use of chatbot

    Perceived ease of use (EU) of the chatbot is measured by the Perceived Ease of Use subscale of the Technology Acceptance Model Questionnaire. This subscale includes six items that assess how easy it is to use the chatbot within the AGILE program that are scored on a Likert scale of 1 = Strongly disagree to 7 = Strongly agree. A composite score is calculated by taking an average of the six items. Higher values on the composite EU score represent a greater perceived ease of use of the chatbot.

    Measured: 12 weeks

  3. Percent weight change

    Percent weight change is defined as weight change from baseline to 12 weeks, calculated as [(weight at 12 weeks - baseline weight) / baseline weight] × 100

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2026
  2. Study start23 Mar 2026
  3. Primary completion21 Sep 2026 (estimated)
  4. Study completion28 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07534254
Sponsor's protocol ID
25-1638
Status last verified
Jun 2026
First submitted
9 Apr 2026
Last updated
26 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AGILE Intervention and Chatbot in people with Overweight and/or Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Program engagement (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07534254.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.

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