A BCT Intervention for Physical Activity Among Individuals on Statins

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

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).

Study Overview

• Status: Completed
• Conditions: Insufficient Physical Activity
• Intervention / Treatment: Behavioral: 5 Behavioral Change Techniques

Detailed Description

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 long-term goal is to prevent CVD. The current project will utilize a modified version of the time-to-event continual reassessment method (TiTE-CRM), a state of the art dose finding methodology, to determine the MED of a multi-component behavioral change technique (BCT) intervention required to increase PA by an average of 2,000 steps per day. 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.

The sample will include individuals on primary prevention statin therapy. For this research, the investigators will enroll currently sedentary persons, with the goal of randomizing 42 persons to the intervention. Enrolled participants will complete a 2-week run-in period where PA levels will be measured using Fitbit wearable devices and levels of adherence to statin medications will be assessed using a smart pill bottle. During the baseline run-in period, objective data from the Fitbit wearable devices will be used to verify sedentary behavior. Individuals who do not have objective levels of sedentary behavior and/or are non-adherent to the protocol will be excluded and will not be randomized to the intervention. Following run-in, the investigators will randomize 42 participants 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 modified TiTE-CRM methodology to adjust the dose for each cohort based on the results from the previous cohort. Following the intervention, all participants will be assessed over a 2-week follow-up period which includes passive data collection from the activity monitor, answering surveys, and use of smart pill bottle to track medication adherence. The MED will be defined as the smallest BCT dose duration associated with 80% of participants having a successful PA increase between the run-in and the follow-up periods. Change in PA will be defined as the difference in average daily PA between the run-in and follow-up periods. The investigators will also assess Mechanisms of Action (MoAs) to determine potential mediators of the BCT intervention on PA. As increasing PA may change statin adherence, the investigators will utilize smart pill bottle to measure adherence to statin medications.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Institute of Health System Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Ages 18 or older;
• Northwell Health employee/affiliate
• Ambulatory without limitations: has never been advised by a clinician that increasing low-intensity walking would be unsafe;
• Prescribed statin medication;
• Self-reported low levels of physical activity
• Access to and capable of using a smart cellular phone;
• After 2 week run-in, objectively-verified low levels of physical activity as documented by a commercially available Fitbit device
• English speaking.

Exclusion Criteria:

• Age less than 18 years;
• Not a Northwell Health employee/affiliate
• Non-ambulatory or unsafe/not recommended to participate in a walking program
• Not prescribed statin medication;
• History of CVD;
• Inability to comply with study protocol during 2 week run-in;
• Does not speak English;
• Unavailable for follow-up;
• Cognitive impairment;
• Severe mental illness (e.g., bipolar disorder or schizophrenia);
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Dose-finding study with 14 groups of 3 participants each. To identify the minimum effective dose (MED) to increase walking by 2,000 more steps per day between run-in and follow-up periods, the first group of 3 participants will receive a 5-week dose of the multi-BCT intervention. For the next subjects, the doses to administrate will vary between 1 and 10 weeks in length and will be determined using a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) according to the observed responses in the previous participants.

Behavioral: 5 Behavioral Change Techniques; 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.; 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.; 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?; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Achieved a 2,000 Step/Day Increase Between run-in and Follow-up	Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by run-in and follow-up periods to generate average daily steps in each period. Average daily steps in the follow-up period will be compared to average daily steps in the run-in period. If the average steps in follow-up are 2,000 steps per day greater than during run-in, the outcome for the Time-to-Event Continual Reassessment Method (TiTE-CRM) will be judged successful. The minimum effective dose (MED) will be defined as the smallest BCT dose duration associated with 80% participants receiving that dose having a successful increase in walking between the run-in and the follow-up periods. Pre-specified to report primary and secondary outcome results across the full sample.	Mean daily step totals will be compared between the run-in (2 weeks pre-intervention) and follow-up periods (2 weeks post-variable intervention of 5-10 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within-person Change in Daily Steps.	Participant steps will be assessed continuously using a Fitbit mobile device. Daily steps for participants will be aggregated by run-in and follow-up periods to generate average daily steps in each period. Changes in daily steps between run-in and intervention periods will be compared using Generalized Linear Mixed Model Analyses. Pre-specified to report primary and secondary outcome results across the full sample.	Mean daily step totals will be compared between the run-in (2 weeks pre-intervention) and follow-up periods (2 weeks post-variable intervention of 5-10 weeks).
Within-person Change in Self-Efficacy for Walking.	Self-efficacy will be assessed using the Self-Efficacy for Walking (SE-W) scale, a 10-item measure assessing patient's capabilities to walk for durations of 5 to 50 minutes. Items are scored from 0 to 100%, with scores of 0% indicating participants are "not at all confident" they could walk for that duration and scores of 100% indicating the participants are "highly confident" they could walk that duration. Items are average to create a total score, with higher scores indicating higher levels of beliefs about self-efficacy. Pre-specified to report primary and secondary outcome results across the full sample.	Self-efficacy will be assessed at the completion of the 2-week run-in and at the end of the 2-week follow-up period. Changes in self-efficacy will be reported comparing mean difference scores between run-in and follow-up (follow-up mean minus run-in mean)
Within-person Change in Intrinsic Regulation.	This will be assessed using a 4-item measure assessing intrinsic regulation, a subscale of the Behavioral Regulations in Exercise Questionnaire Version 2 (BREQ-2). Items are scored on a 0 (Not true for me) to 4 (Very true for me) scale, and averaged to create a total score, with higher scores indicating greater intrinsic regulation. Pre-specified to report primary and secondary outcome results across the full sample.	Intrinsic regulation (IR) will be assessed at the completion of the 2-week run-in and end of the 2-week follow-up period. Changes in IR will be reported comparing mean difference scores between run-in and follow-up (follow-up mean minus run-in mean)
Within-person Change in Discrepancy in Behavior.	This will be assessed with a single item measuring discrepancy in behavior. The text of the measure is "How large is the difference between your current walking behavior and your goal concerning your walking?" The question is rated from 1 (Not at all different) to 7 (very different) with higher scores indicating greater levels of discrepancy in behavior. Pre-specified to report primary and secondary outcome results across the full sample.	Discrepancy in behavior (DIB) will be assessed at the completion of the 2-week run-in and end of the 2-week follow-up period. Changes in DIB will be reported comparing mean difference scores between run-in and follow-up (follow-up mean minus run-in mean)
Within-person Change in Motivation.	Motivation will be assessed with a message stating "I feel motivated to walk each day." Participants will rate this item on a scale of 1 (Not true at all) to 7 (Very true) with higher scores indicating higher levels of motivation. Pre-specified to report primary and secondary outcome results across the full sample.	Motivation will be assessed at the completion of the 2-week run-in and at the end of the 2-week follow-up period. Changes in motivation will be reported comparing the mean difference scores between run-in and follow-up (follow-up mean minus run-in mean)
Within-person Change in Environmental Context and Resources.	This will be assessed using a checklist of 7 potential barriers to walking. Barriers are coded on a 1 (Not often at all) to 5 (Very often) scale, and averaged to create a total score, with higher scores indicating that the listed barriers had greater effects on walking. Pre-specified to report primary and secondary outcome results across the full sample.	Environmental context and resources (ECaR) will be assessed at completion of 2-week run-in & end of 2-week follow-up period. Changes in ECaR will be reported comparing mean difference scores between run-in & follow-up (follow-up mean minus run-in mean)
Within-person Change in Medication Adherence.	Participant adherence to statin medication will be assessed continuously using a smart electronic pill bottle. Daily medication adherence will be recorded for each participant across the full duration of the study. Changes in medication between run-in and intervention phases will be compared using Generalized Linear Mixed Model Analyses. Adherence during run-in and follow-up periods will be reported as the proportion of days adherent (e.g. 0.786 for 11 out of 14 days adherent). Changes in adherence between run-in and follow-up will be reported as the mean change in proportion of days adherent	Medication adherence will be assessed continuously via a smart pill bottle and adherence will be calculated daily. Change over time will be examined between the 2-week run-in and the follow-up period (2 weeks post-variable intervention of 5-10 weeks).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between-person Heterogeneity in Treatment Response.	Participant heterogeneity in amount of time required to reach a successful increase in daily steps (defined as an increase of 2,000 or more steps per day over a 2-week period compared to run-in) will be examined. Average step counts will be calculated for each 2-week block during the intervention and follow-up periods. Average steps per day in these blocks will be compared with the average daily steps in the run-in period. Once a successful increase has been detected, the time to achieve this treatment response will be recorded. Differences in duration to successful increases in physical activity will be examined between participants using mixed effects regression models. Pre-specified to report primary and secondary outcome results across the full sample.	Steps will be assessed continuously via worn activity tracker and step counts will be reported daily. Step counts will be averaged during the 2-weeks of run-in and by 2-week blocks during the intervention and follow-up period (5-14 weeks from run-in).

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Karina Davidson, PhD, MASc, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Actual): July 28, 2023
• Study Completion (Actual): July 28, 2023

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; Cardiovascular Disease; Walking; Statins; Dose Finding; Behavior Change; Continual Reassessment Method
• Other Study ID Numbers: 21-0674; P30AG063786-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary.
• IPD Sharing Time Frame: The study protocol, including the statistical analysis plan, will be made available in addition to the informed consent form following completion of recruitment but prior to publication of any data from the current study. De-identified, pooled individual participant data will be made available within a year of final participant data collection. We anticipate this data to be available on the Open Science Framework platform indefinitely.
• IPD Sharing Access Criteria: All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No