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Insufficient Physical ActivityPhase 1NCT05273723

A BCT Intervention for Physical Activity Among Individuals on Statins

A Phase 1 study testing 5 Behavioral Change Techniques in people with Insufficient Physical Activity, run by Northwell Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Insufficient Physical Activity
What is being tested?
5 Behavioral Change Techniques
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
22 Mar 2022to 28 Jul 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 11Show fewer
  • Does not speak English;
  • Unavailable for follow-up;
  • Cognitive impairment;
  • Severe mental illness (e.g., bipolar disorder or schizophrenia);
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Institute of Health System Science

    New York, New York, 10022

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
5 Behavioral Change Techniques
Keywords
Behavior Change, Physical Activity, Walking, Statins, Cardiovascular Disease, Dose Finding, Continual Reassessment Method
Medical subject headings
Motor Activity, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5 Behavioral Change TechniquesBehavioural

    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.
Study groups in NCT05273723
Study groupRoleWhat they receive
InterventionExperimentalDose-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.
Receives: Behavioral: 5 Behavioral Change Techniques

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: 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).

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

  7. 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

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2022
  2. Study start22 Mar 2022
  3. Primary completion28 Jul 2023
  4. Study completion28 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Sequential
Model description
The study utilizes a modified Time-to-Event Continual Reassessment Method Dose-Finding Design
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05273723
Sponsor's protocol ID
21-0674
Other IDs
P30AG063786-01
Status last verified
Jun 2026
First submitted
27 Dec 2021
Last updated
29 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary.

Publications

  • 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.

    PubMed 40764069

  • 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.

    PubMed 37105318

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 5 Behavioral Change Techniques in people with Insufficient Physical Activity, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Achieved a 2,000 Step/Day Increase Between run-in and Follow-up (time frame: 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05273723, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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