Actively Recruiting

Phase Not Applicable
Age: 18Years - 39Years
All Genders
Healthy Volunteers
ID07534254

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

Led by University of North Carolina, Chapel Hill · Updated on 2026-04-22

20

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

U

UNC Gillings School of Global Public Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding a generative artificial intelligence chatbot to a 12-week smartphone-based behavioral weight loss program is feasible and helpful for young adults aged 18 to 39 with overweight or obesity. The study aims to compare the standard program, which sends 1-2 brief daily messages, with the same program enhanced by a chatbot offering extra behavior change support to improve engagement and weight loss. Participants will be randomly assigned to one of two groups: the standard AGILE behavioral weight loss program or the AGILE program plus a chatbot integrated into the app. Both programs include weekly lessons, personalized goals, self-monitoring of diet, activity, and weight, and tailored feedback. The chatbot provides additional cognitive behavioral support through brief daily conversations to help with tracking, overcoming barriers, and staying motivated. During the 12-week program, researchers will assess participant engagement with the program and chatbot, weight changes, and user acceptability of the chatbot. Participants will use a Fitbit tracker and scale to monitor physical activity and weight. Assessments occur at the start and end of the 12 weeks to measure outcomes such as program engagement, chatbot use, perceived usefulness, ease of use, and percent weight change.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 39Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Body mass index (BMI) of 25-45 kg/m²
  • English-speaking and writing
  • Own an iPhone with a data plan
  • Willing to be randomized to either treatment group
  • Age between 18 and 39 years
Not Eligible

You will not qualify if you...

  • Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
  • Health problems affecting ability to walk or causing unintentional weight change, including tuberculosis, current cancer treatment, or history of heart attack or stroke
  • Report heart condition, chest pain during activity or rest, loss of consciousness, or any reason preventing walking 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 surgery in next 4 months
  • Past or current diagnosis or treatment for anorexia nervosa or bulimia nervosa
  • Currently pregnant or planning pregnancy within 4 months
  • Health or psychological diagnoses preventing participation in prescribed diet and exercise, including schizophrenia, bipolar disorder, recent psychiatric hospitalization, or current substance abuse
  • Another household member is a participant or staff in this trial
  • Currently participating in another weight loss, nutrition, physical activity study, or conflicting study
  • Not willing to wear a Fitbit daily
  • Participated in another study by the UNC Weight Research Program in past 12 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Treatment

Duration - 12 weeks

Participants receive a 12-week mobile behavioral weight loss intervention via a smartphone app, including weekly lessons, personalized goals, self-monitoring, weekly tailored feedback, and daily tailored messages. Participants in one group also have access to a chatbot for brief conversations 1-2 times per day to support behavior change.

Assessments at baseline and Week 12

Trial Site Locations

Total: 1 location

1

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

Loading map...

Research Team

B

Brooke T Nezami, PhD

K

Karen Hatley, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

A Multicenter, Multiple-dose Escalation, Randomized, Double-...

Overweight and/or Obesity

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here