Clinical trial NCT05751993: Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions
Official title: Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Overweight
Obesity
Keywords: cancer
risk factor
just-in-time adaptive intervention (JITAI)
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: RTI International
name: National Cancer Institute (NCI)
First posted: 2023-03-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Reinforcement Learning (RL), a type of machine learning, holds promise for addressing the limitations of previous approaches to implementing JITAIs. Adaptive RL applications work by updating information about expected "rewards" (i.e., proximal outcomes) based on the results of sequentially randomized trials. To realize the potential of adaptive interventions to reduce health disparities in cancer prevention and control, mHealth interventionists first need to identify methods of using digital health participant data to continually adapt decision rules guiding highly tailored intervention delivery. This research team has developed a reinforcement learning model (AdaptRL) that reads in and analyzes user data (e.g., calories, weight, and activity data from Fitbit) in real-time, uses RL to efficiently determine which message a participant should receive up to 3 times per day, and creates a JITAI tailored to optimize daily behavioral goal achievement and weight loss for each participant. The objective of this study is to test the feasibility of using this reinforcement learning model in a pilot weight loss study.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility (success of using the AdaptRL model)
timeFrame: up to 12 weeks
measure: Study engagement
timeFrame: up to 12 weeks
measure: Self-monitoring adherence
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Percent weight loss
timeFrame: 12 weeks
measure: Moderate-to-vigorous physical activity
timeFrame: Baseline, 12 weeks
measure: Dietary intake
timeFrame: Baseline, 12 weeks
measure: Adherence to calorie goal
timeFrame: up to 12 weeks
measure: Adherence to daily active minutes goal
timeFrame: up to 12 weeks
measure: Adherence to daily self-weighing
timeFrame: up to 12 weeks
measure: Adherence to daily self-weighing at the participant-day level
timeFrame: up to 12 weeks
measure: Adherence to the daily self-weighing percent of person-days weighed
timeFrame: up to 12 weeks
measure: Achievement of active minutes goal
timeFrame: up to 12 weeks
measure: Achievement of active minutes goal percent of person-days
timeFrame: up to 12 weeks
measure: Achievement of calorie goal (at or under goal)
timeFrame: up to 12 weeks
measure: Achievement of calorie goal (at or under goal) percent of person-days
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Brooke Nezami, PhD, MA
role: PRINCIPAL_INVESTIGATOR
References: