A BCT Intervention for Physical Activity Among Individuals on Statins

NCT05273723 | Completed Phase 1 Results DMC

• 2 other identifiers: 21-0674P30AG063786-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Insufficient Physical Activity

Keywords

Behavior Change; Physical Activity; Walking; Statins; Cardiovascular Disease; Dose Finding; Continual Reassessment Method

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Within-person Change in Daily Steps.

  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 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.

  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.

  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 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)

Other Outcomes (1)

• Between-person Heterogeneity in Treatment Response.

  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).

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

5 Behavioral Change Techniques BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Institute of Health System Science

New York, New York, 10022, United States

Location

Related Publications (2)

• Goodwin AM, Friel C, Miller D, Vicari F, Duer-Hefele J, Chandereng T, Davidson KW, Alfano CM, Cheung YK, Butler MJ. Minimum effective dose of a multicomponent behaviour change intervention to increase the physical activity of individuals on primary statin therapy: an adaptive study using the time-to-event continual reassessment method (TiTE-CRM). BMJ Open. 2025 Aug 5;15(8):e090789. doi: 10.1136/bmjopen-2024-090789.

  PMID: 40764069 DERIVED

• Butler MJ, Romain AN, Augustin R, Robles P, Friel CP, Vicari F, Chandereng T, Alfano CM, Cheung YK, Davidson KW. The effect of a multi-component behavior change technique intervention on physical activity among individuals on primary prevention statin therapy: A dose-finding trial protocol. Contemp Clin Trials. 2023 Jul;130:107205. doi: 10.1016/j.cct.2023.107205. Epub 2023 Apr 25.

  PMID: 37105318 DERIVED

MeSH Terms

Conditions

Motor Activity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Karina Davidson
• Organization: Northwell Health

kdavidson2@northwell.edu

(516) 562-3467

Study Officials

• Karina Davidson, PhD, MASc

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study utilizes a modified Time-to-Event Continual Reassessment Method Dose-Finding Design

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: March 10, 2022
• Study Start: March 22, 2022
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: December 31, 2024
• Results First Posted: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.

Locations

US (1)