Back to resultsPiloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions
Primary Purpose
Overweight and Obesity, Overweight, Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADAPT
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring cancer, risk factor, just-in-time adaptive intervention (JITAI)
Eligibility Criteria
Inclusion Criteria: Age 18-55 years Body Mass Index of 25-40 kg/m2 Not adhering to the US physical activity guidelines of at least 150 moderate-to-vigorous intensity activity minutes/week English-speaking and writing No 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 Has a smartphone with a data and text messaging plan Exclusion Criteria: Current participation in another weight loss, physical activity, nutrition program, or research study Currently taking weight loss medications Currently pregnant or planning pregnancy in the next 3 months Lost 10 or more pounds and kept it off in the last 6 months History of weight loss surgery Report a heart condition, chest pain during periods of activity or rest, loss of consciousness, joint or bone problems, medical conditions that could limit exercise, or prescription medicine used for blood pressure or heart condition on the Physical Activity Readiness Questionnaire (PAR-Q) Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes Cancer treatment within the past 5 years Tuberculosis Health or psychological diagnoses that preclude participation in a prescribed dietary and exercise program, including diagnosis of schizophrenia or bipolar disorder, hospitalization for a psychiatric diagnosis in the past year, a diagnosis of alcohol or substance abuse Report a past diagnosis of or receiving treatment for The Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) eating disorder (anorexia nervosa or bulimia nervosa). Moving out of the area in the next 4 months Out of town for a week or more during the study period Another member of the household is a participant or staff member in this trial Not willing to attend two study visits Not willing to wear a Fitbit every day
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ADAPT intervention
Arm 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 which they will be able to rate (like/dislike), along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
Outcomes
Primary Outcome Measures
Feasibility (success of using the AdaptRL Tool)
Feasibility as the success of using the AdaptRL Tool will be defined as the mean number of messages delivered per participant per day.
Study engagement
Study engagement will be defined as the percent of person-days in which participants accessed the web app.
Self-monitoring adherence
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).
Secondary Outcome Measures
Message satisfaction
Message satisfaction will be defined as the percent of delivered messages that were rated as "liked" (compared to dislike or not rated).
Percent weight loss
Percent weight loss will be defined as weight change from baseline to 12 weeks calculated as a percent from baseline weight.
Moderate-to-vigorous physical activity
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.
Dietary intake
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.
Adherence to calorie goal
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.
Adherence to daily active minutes goal
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.
Adherence to daily self-weighing
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.
Adherence to daily self-weighing at the participant-day level
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.
Adherence to the daily self-weighing percent of person-days weighed
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.
Achievement of active minutes goal
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.
Achievement of active minutes goal percent of person-days
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.
Achievement of calorie goal (at or under goal)
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.
Achievement of calorie goal (at or under goal) percent of person-days
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.
Full Information
NCT ID
NCT05751993
First Posted
February 20, 2023
Last Updated
October 23, 2023
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Duke University, RTI International, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05751993
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
Duke University, RTI International, National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this pilot study is to conduct a 12-week pilot feasibility study testing usability of the adapt learning tool (AdaptRL)in a weight loss intervention (ADAPT study). Building upon a previous just-in-time adaptive intervention (JITAI), a reinforcement learning tool will generate decision rules regarding which behavior change techniques, in which contexts, are most efficacious for promoting 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. In the context of mHealth, random delivery of intervention messages is referred to as a micro-randomized trial. To realize the potential of adaptive interventions to reduce health disparities in cancer prevention and control, mHealth interventionists first need a user-friendly RL tool that enables use of digital health participant data to continually adapt decision rules guiding highly tailored intervention delivery. This research team has developed a user-friendly, web-based application (AdaptRL) that reads in and analyzes user data (e.g., from Fitbit) in real-time, uses RL to efficiently conduct micro-randomized trials, and creates a JITAI tailored to optimize weight loss for each participant. The objective of this study is to test the feasibility of using the AdaptRL tool in a pilot weight loss study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Overweight, Obesity
Keywords
cancer, risk factor, just-in-time adaptive intervention (JITAI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ADAPT intervention
Arm Type
Experimental
Arm 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 which they will be able to rate (like/dislike), along with weekly personalized feedback, progress graphs, and lessons and resources available on the website.
Intervention Type
Behavioral
Intervention Name(s)
ADAPT
Intervention Description
The intervention is testing the feasibility of a reinforcement learning tool 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 (early morning, morning, midday, and evening on a daily basis), the system evaluates which intervention options a participant is eligible to receive, and randomly chooses one intervention option from that list. Then the participant is randomly assigned to either receive or not receive that intervention message (with a 50-50 probability).
Primary Outcome Measure Information:
Title
Feasibility (success of using the AdaptRL Tool)
Description
Feasibility as the success of using the AdaptRL Tool will be defined as the mean number of messages delivered per participant per day.
Time Frame
up to 12 weeks
Title
Study engagement
Description
Study engagement will be defined as the percent of person-days in which participants accessed the web app.
Time Frame
up to 12 weeks
Title
Self-monitoring adherence
Description
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
up to 12 weeks
Secondary Outcome Measure Information:
Title
Message satisfaction
Description
Message satisfaction will be defined as the percent of delivered messages that were rated as "liked" (compared to dislike or not rated).
Time Frame
up to 12 weeks
Title
Percent weight loss
Description
Percent weight loss will be defined as weight change from baseline to 12 weeks calculated as a percent from baseline weight.
Time Frame
12 weeks
Title
Moderate-to-vigorous physical activity
Description
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
Title
Dietary intake
Description
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
Baseline, 12 weeks
Title
Adherence to calorie goal
Description
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
Title
Adherence to daily active minutes goal
Description
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
Title
Adherence to daily self-weighing
Description
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
Title
Adherence to daily self-weighing at the participant-day level
Description
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
Title
Adherence to the daily self-weighing percent of person-days weighed
Description
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
Title
Achievement of active minutes goal
Description
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
Title
Achievement of active minutes goal percent of person-days
Description
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
Title
Achievement of calorie goal (at or under goal)
Description
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
Title
Achievement of calorie goal (at or under goal) percent of person-days
Description
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.
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-55 years
Body Mass Index of 25-40 kg/m2
Not adhering to the US physical activity guidelines of at least 150 moderate-to-vigorous intensity activity minutes/week
English-speaking and writing
No 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
Has a smartphone with a data and text messaging plan
Exclusion Criteria:
Current participation in another weight loss, physical activity, nutrition program, or research study
Currently taking weight loss medications
Currently pregnant or planning pregnancy in the next 3 months
Lost 10 or more pounds and kept it off in the last 6 months
History of weight loss surgery
Report a heart condition, chest pain during periods of activity or rest, loss of consciousness, joint or bone problems, medical conditions that could limit exercise, or prescription medicine used for blood pressure or heart condition on the Physical Activity Readiness Questionnaire (PAR-Q)
Type 1 diabetes or currently receiving medical treatment for Type 2 diabetes
Cancer treatment within the past 5 years
Tuberculosis
Health or psychological diagnoses that preclude participation in a prescribed dietary and exercise program, including diagnosis of schizophrenia or bipolar disorder, hospitalization for a psychiatric diagnosis in the past year, a diagnosis of alcohol or substance abuse
Report a past diagnosis of or receiving treatment for The Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) eating disorder (anorexia nervosa or bulimia nervosa).
Moving out of the area in the next 4 months
Out of town for a week or more during the study period
Another member of the household is a participant or staff member in this trial
Not willing to attend two study visits
Not willing to wear a Fitbit every day
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Nezami, PhD, MA
Phone
919-966-5852
Email
bnezami@unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nisha Gottfredson, PhD
Phone
919-248-1826
Email
ngottfredson@rti.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brooke Nezami, PhD, MA
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brooke Nezami, PhD, MA
Phone
919-966-5852
Email
bnezami@unc.edu
First Name & Middle Initial & Last Name & Degree
Marina Pearsall, MPH, RDN
Phone
919-966-1601
Email
mpear@email.unc.edu
First Name & Middle Initial & Last Name & Degree
Brooke Nezami, PhD, MA
First Name & Middle Initial & Last Name & Degree
Nisha Gottfredson, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
Description
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Learn more about this trial
Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions
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