Chatbot-enhanced 12-week smartphone weight-loss program for young adults

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

Not applicable Interventional University of North Carolina, Chapel Hill · NCT07534254

This study will test whether adding a chatbot to a 12-week smartphone weight-loss program helps young adults with overweight or obesity lose more weight and stay more engaged.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment20 (estimated)
Ages18 Years to 39 Years
SexAll
SponsorUniversity of North Carolina, Chapel Hill Academic / other
Locations1 site (Chapel Hill, North Carolina)
Trial IDNCT07534254 on ClinicalTrials.gov

What this trial studies

Twenty young adults ages 18 to 39 with BMI 25–45 kg/m2 will be randomized to one of two 12-week smartphone-delivered behavioral weight-loss programs: the standard AGILE program or AGILE plus an integrated chatbot. Both arms receive weekly lessons, personalized goals, self-monitoring of diet, activity, and weight, tailored feedback, and brief daily messages, while the chatbot arm can have brief conversational interactions 1–2 times per day. The study will measure feasibility, acceptability, program engagement, and weight change with assessments at baseline and 12 weeks. This pilot is designed to determine whether the chatbot increases engagement and improves short-term weight outcomes compared with the standard app alone.

Who should consider this trial

Good fit: Ideal candidates are English-speaking young adults aged 18–39 with a BMI of 25–45 kg/m2 who own an iPhone with a data plan and are willing to be randomized.

Not a fit: People with type 1 diabetes or current medical treatment for type 2 diabetes, major health problems limiting walking, recent significant weight loss, current weight-loss medications, or planned/previous weight-loss surgery are unlikely to benefit from this pilot.

Why it matters

Potential benefit: If successful, adding a chatbot could help young adults stick with the program and achieve greater short-term weight loss by providing additional tailored support on their phone.

How similar studies have performed: Previous smartphone behavioral weight-loss programs have shown modest benefits and early chatbot interventions for behavior change show promise but currently have limited and preliminary evidence.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Chapel Hill, North Carolina

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Overweight and/or ObesityBehavioral interventionWeight lossmHealth intervention
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.