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A BCT Intervention for Physical Activity Among Individuals on Statins
Sponsor: Northwell Health
Summary
The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change intervention required to increase levels of physical activity (PA) among participants on primary prevention statin therapy who are at elevated risk for cardiovascular disease (CVD). The intervention will be comprised of 5 BCTs which have previously shown to be effective on increasing health behaviors: Goal Setting, Action Planning, Self-Monitoring, Feedback, and Prompts/Cues. Participants will complete a 2-week baseline run-in period where PA levels will be measured using Fitbit wearable device. Then 42 participants will be randomized into 14 cohorts of 3 participants each for the intervention period. During the intervention period, participants will receive a multi-BCT intervention, the length of which varies between 1 and 10 weeks depending on the assigned dose. Assignment to doses will utilize a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) methodology to adjust the dose for each cohort based on the results from the previous cohort. After the intervention, there will be a 2-week follow-up period. The MED will be defined as the smallest BCT dose (defined by weeks of intervention) associated with 80% of participants having a successful PA increase between the run-in and the follow-up periods (defined as walking an extra 2,000 more steps per day).
Official title: The Effect of a Multi-Component Behavior Change Technique Intervention on Physical Activity Among Individuals on Primary Prevention Statin Therapy: A Dose-Finding Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2022-03-22
Completion Date
2023-07-28
Last Updated
2026-06-29
Healthy Volunteers
Yes
Conditions
Interventions
5 Behavioral Change Techniques
1. Goal setting: set or agree on a goal defined in terms of behavior to be achieved. Example: Set the goal of walking 2,000 steps more per day. 2. Action planning: prompt detailed planning of performance of behavior (must include a setting \[walking to the mailbox\], frequency, duration, and intensity. Example: Develop a plan to walk today. 3. Self-Monitoring of behavior: establish a method for person to monitor and record their number of steps based on their Fitbit. Example: Did you check your Fitbit and record daily total number of steps? 4. Feedback on behavior: Monitor and provide informative or evaluative feedback on performance of the behavior (e.g. form, frequency, duration, intensity). Example: You walked 6,000 steps today. 5. Prompts/Cues: introduce or define environmental or social stimulus with the purpose of prompting or cueing the behavior. The prompt or cue would normally occur at the time or place of performance. Example: You planned to walk today in the park at 3pm.
Locations (1)
Institute of Health System Science
New York, New York, United States