Efficacy, effectiveness, and behavior change trials in exercise research
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Efficacy, effectiveness, and behavior change trials in exercise research Kerry S Courneya
Abstract Background: The widespread incorporation of behavioral support interventions into exercise trials has sometimes caused confusion concerning the primary purpose of a trial. The purpose of the present paper is to offer some conceptual and methodological distinctions among three types of exercise trials with a view towards improving their design, conduct, reporting, and interpretation. Discussion: Exercise trials can be divided into “health outcome trials” or “behavior change trials” based on their primary outcome. Health outcome trials can be further divided into efficacy and effectiveness trials based on their potential for dissemination into practice. Exercise efficacy trials may achieve high levels of exercise adherence by supervising the exercise over a short intervention period ("traditional” exercise efficacy trials) or by the adoption of an extensive behavioral support intervention designed to accommodate unsupervised exercise and/or an extended intervention period ("contemporary” exercise efficacy trials). Exercise effectiveness trials may emanate from the desire to test exercise interventions with proven efficacy ("traditional” exercise effectiveness trials) or the desire to test behavioral support interventions with proven feasibility ("contemporary” exercise effectiveness trials). Efficacy, effectiveness, and behavior change trials often differ in terms of their primary and secondary outcomes, theoretical models adopted, selection of participants, nature of the exercise and comparison interventions, nature of the behavioral support intervention, sample size calculation, and interpretation of trial results. Summary: Exercise researchers are encouraged to clarify the primary purpose of their trial to facilitate its design, conduct, and interpretation. Randomized controlled trials (RCTs) are a common design for testing many health interventions including exercise. In recent years, exercise RCTs have become more complex and challenging because of a greater focus on methodological rigor and the desire to test longer exercise interventions, unsupervised exercise interventions, and higher volume exercise interventions. These changes have necessitated a greater focus on exercise adherence in these trials and have stimulated the incorporation of behavioral support interventions into many exercise trials for which behavior change was not the primary purpose. Behavioral support interventions consist of strategies to improve exercise adherence such as incentives, print materials, telephone counselling, group sessions, websites, and other behavior modification techniques. The incorporation of behavioral Correspondence: [email protected] Faculty of Physical Education and Recreation, University of Alberta, Edmonton, Alberta, Canada
support interventions into exercise RCTs has been a major methodological advance in exercise research, however, it has sometimes caused confusion concerning the pr
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