COMPLETED

Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this pilot study is to conduct a 12-week pilot feasibility study testing usability of a reinforcement learning model (AdaptRL) in a weight loss intervention (ADAPT study). Building upon a previous just-in-time adaptive intervention (JITAI), a reinforcement learning model will generate decision rules unique to each individual that are intended to improve the tailoring of brief intervention messages (e.g., what behavior to message about, what behavior change techniques to include), improve achievement of daily behavioral goals, and improve weight loss in a sample of 20 adults.

Official Title

Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions

Quick Facts

Study Start:2025-04-12
Study Completion:2025-08-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05751993

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18-55 years
  2. 2. Body Mass Index of 25-40 kg/m2
  3. 3. English-speaking and writing
  4. 4. Has a smartphone with a data and text messaging plan
  1. 1. Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study
  2. 2. Currently using prescription medications with known effects on appetite or weight (e.g., oral steroids, weight loss medications), with the exception of individuals on a stable dose of SSRIs for 3 months)
  3. 3. Previous surgical procedure for weight loss or planned weight loss surgery in the next year
  4. 4. Currently pregnant or planning pregnancy in the next 4 months
  5. 5. Lost 10 or more pounds and kept it off in the last 6 months
  6. 6. 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). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate
  7. 7. Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, diabetes treated with insulin, history of heart attack or stroke, current treatment for cancer, or inability to walk for exercise
  8. 8. Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
  9. 9. Other health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis
  10. 10. 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, a current diagnosis of alcohol or substance abuse
  11. 11. Report a past diagnosis of or receiving treatment for a DSM-5-TR eating disorder (anorexia nervosa, bulimia nervosa, or other diagnosis)
  12. 12. Another member of the household is a participant or staff member in this trial
  13. 13. Not willing to attend one study visit
  14. 14. Not willing to wear a Fitbit every day
  15. 15. Reason to suspect that the participant would not adhere to the study intervention
  16. 16. Have participated in another study conducted by the UNC Weight Research Program within the past 12 months

Contacts and Locations

Principal Investigator

Brooke Nezami, PhD, MA
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Brooke Nezami, PhD, MA, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-12
Study Completion Date2025-08-18

Study Record Updates

Study Start Date2025-04-12
Study Completion Date2025-08-18

Terms related to this study

Keywords Provided by Researchers

  • cancer
  • risk factor
  • just-in-time adaptive intervention (JITAI)

Additional Relevant MeSH Terms

  • Overweight and Obesity
  • Overweight
  • Obesity