Clinical trial · Interventional
Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions
NCT05751993CI-TRIAL-00123216completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity | — | UNRESOLVED | — |
| Overweight | — | UNRESOLVED | — |
| Overweight and Obesity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADAPT | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ADAPT intervention
- description
- Participants will receive a smart scale and a physical activity tracker and will have three daily goals: weigh daily, a daily personalized active minutes goal, and a daily calorie goal. For 12 weeks, participants will receive 0-3 text messages per day about their behaviors and progress towards their goals, along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
- interventionNames
- Behavioral: ADAPT
Primary outcomes (3)
- measure
- Feasibility: Messages Delivered
- timeFrame
- up to 12 weeks
- description
- Feasibility as the success of using the AdaptRL model will be defined as the mean number of messages delivered per participant per day.
- measure
- Study Engagement: Percent of Days With Logins
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-55 years 2. Body Mass Index of 25-40 kg/m2 3. English-speaking and writing 4. Has a smartphone with a data and text messaging plan Exclusion Criteria: 1. Currently participating in a weight loss, nutrition, or physical activity study or program or other study that would interfere with this study 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. Previous surgical procedure for weight loss or planned weight loss surgery in the next year 4. Currently pregnant or planning pregnancy in the next 4 months 5. Lost 10 or more pounds and kept it off in the last 6 months 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. 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. Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes 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. 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. Report a past diagnosis of or receiving treatment for a DSM-5-TR eating disorder (anorexia nervosa, bulimia nervosa, or other diagnosis) 12. Another member of the household is a participant or staff member in this trial 13. Not willing to attend one study visit 14. Not willing to wear a Fitbit every day 15. Reason to suspect that the participant would not adhere to the study intervention 16. Have participated in another study conducted by the UNC Weight Research Program within the past 12 months
References
Publications (0)
Data not yet available
No reference posted for this study.