A BCT Intervention for Physical Activity Among Individuals on Statins

NCT ID: NCT05273723

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-22
• Study Completion Date: 2023-07-28

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).

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.

Conditions

Insufficient Physical Activity

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

5 Behavioral Change Techniques

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karina Davidson, PhD, MASc

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Institute of Health System Science

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40764069 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37105318 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P30AG063786-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-0674

Identifier Type: -

Identifier Source: org_study_id