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. 2023 Jul:130:107205.
doi: 10.1016/j.cct.2023.107205. Epub 2023 Apr 25.

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

Mark J Butler  1 , Anne-Marie N Romain  2 , Rumisha Augustin  3 , Patrick Robles  4 , Ciaran P Friel  4 , Frank Vicari  4 , Thevaa Chandereng  4 , Catherine M Alfano  5 , Ying-Kuen Cheung  6 , Karina W Davidson  7
Affiliations

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

Mark J Butler et al. Contemp Clin Trials. 2023 Jul.

Abstract

Background: Statin therapy is a mainstay of cardiovascular disease (CVD) prevention, but research shows that statin therapy alone is insufficient for preventing incident CVD and mortality. Combining statin medication with increased physical activity (PA) can lower mortality risk more than either statin or PA alone. However, PA levels often remain the same and may even decline following statin prescription. Additional information is needed to identify how to increase PA among statin users and determine the minimal length of an intervention (i.e., intervention dose) necessary to increase PA.

Objective: The study aims to identify the required dose of a behavior change technique (BCT) intervention to increase PA among individuals on primary prevention statin therapy who have an elevated risk for cardiovascular disease (CVD).

Methods: The study will utilize the modified time-to-event continual reassessment method (TiTE-CRM) in 42 participants. We expect insights relating to dose-efficacy models and BCTs (Behavior Change Techniques) to improve PA in adults at risk for CVD. This trial will also examine potential mechanisms of action (MoAs) for interventions to increase PA, identify any effect a PA intervention may have on medication adherence, and determine whether participants respond uniformly to their respective behavioral interventions.

Ethics and dissemination: This trial was approved by the Northwell Health Institutional Review Board (IRB) and all participants will complete informed consent. The trial results will be published in a peer-reviewed journal. All publications resulting from this series of personalized trials will follow the CONSORT reporting guidelines.

Registration details: This trial is registered on www.

Clinicaltrials: gov (Number NCT05273723).

Keywords: Behavior change techniques (BCT); Cardiovascular disease (CVD); Dose finding; Personalized; Personalized trial; Physical activity; Statin; Virtual.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1.
Figure 1.
TiTE-CRM dose selection scenario Note: Following the first cohort (which receives a 5-week intervention dose), if most participants are successful in achieving their goal of an increase in walking (i.e., ≥ 2,000 steps/day in follow-up compared with baseline), a lower dose will be administered to the next cohort; in this example, a 3-week intervention dose. If there is no increase in walking, the subsequent cohort will receive a longer dose intervention (7-week duration in this example). This process will continue with each subsequent cohorts dose being informed by the performance of participants in the prior cohort.
Figure 2.
Figure 2.
Potential trial dose assignment scenarios using TiTE-CRM
Figure 3.
Figure 3.
Participant timeline
See this image and copyright information in PMC

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