University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
NCT Number: NCT05751993
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.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27514, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention is testing the feasibility of a reinforcement learning model to pull in participants' behavioral data (calories, activity, and weight) and use this data along with participants' past behavioral goal achievements to deliver the type of message that should be most effective for a given participant at a given time. At each decision point (morning, midday, and evening on a daily basis), the system evaluates which behaviors a participant is eligible to receive a message about (eating, activity, self-weighing), which intervention options a participant is eligible to receive, and then chooses what type of behavioral message a participant should receive. Over time, the model uses participant data and response to interventions to better tailor message choice.
Time frame: up to 12 weeks
Feasibility as the success of using the AdaptRL model will be defined as the mean number of messages delivered per participant per day.
Time frame: up to 12 weeks
Study engagement will be defined as the percent of person-days in which participants accessed the web app.
Time frame: up to 12 weeks
Self-monitoring adherence will be defined as the percent of person-days in which participants tracked at least one weight loss behavior (tracked calories, wore tracker, or self-weighed).
Time frame: 12 weeks
Percent weight loss will be defined as weight change from baseline to 12 weeks calculated as a percent from baseline weight.
Time frame: Baseline, 12 weeks
Moderate-to-vigorous physical activity will be defined as the change in self-reported weekly minutes of moderate-to-vigorous physical activity as measured by the Paffenbarger Activity Questionnaire from baseline to 12 weeks. The minimum is 0, no maximum. Higher numbers represent higher minutes of weekly moderate-to-vigorous physical activity.
Time frame: Baseline, 12 weeks
Dietary intake will be defined as the change in average daily calorie intake as measured by the Automated Self-Administered 24-hour (ASA 24-hour) dietary recalls from baseline to 12 weeks. Daily caloric intake is measured in kcals, with higher numbers indicating higher caloric intake.
Time frame: up to 12 weeks
Adherence to the calorie goal as the percent of person-days in which participants tracked their calories and stayed at or under their calorie goal will be measured by dietary self-monitoring data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers.
Time frame: up to 12 weeks
Adherence to daily active minutes goal, the percent of person-days in which participants met their daily active minute goal, will be measured by activity tracker data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers.
Time frame: up to 12 weeks
Adherence to daily self-weighing, the percent of person-days in which participants self-weighed will be measured by Fitbit smart scales and transmitted via Application Programming Interface (API) to study servers.
Time frame: up to 12 weeks
Adherence to daily self-weighing at the participant-day level, the percent of person-days weighed after the message randomization time until the end of the day will be measured by Fitbit smart scales and transmitted via Application Programming Interface (API) to study servers.
Time frame: up to 12 weeks
Adherence to the daily self-weighing percent of person-days weighed the day after the message randomization will be measured by Fitbit smart scales and transmitted via Application Programming Interface (API) to study servers.
Time frame: up to 12 weeks
Achievement of active minutes goal, percent of person-days met active minutes goal after the message randomization time until the end of the day will be measured by activity tracker data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers.
Time frame: up to 12 weeks
Achievement of active minutes goal percent of person-days met active minutes goal the day after the message randomization will be measured by activity tracker data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers.
Time frame: up to 12 weeks
Achievement of calorie goal (at or under goal) percent of person-days met calorie goal after the message randomization time until the end of the day will be measured by dietary self-monitoring data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers.
Time frame: up to 12 weeks
Achievement of calorie goal (at or under goal) percent of person-days met calorie goal the day after the message randomization will be measured by dietary self-monitoring data tracked in the Fitbit app and transmitted via Application Programming Interface (API) to study servers.
UNC Lineberger Comprehensive Cancer Center
Other
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