An examination of theory and behavior change in randomized clinical trials

This paper underscores the important role Flayed by theory-based mediating variables in randomized clinical trials. Indeed, it is essential that we kn ow what mediating variables are relevant for particular outcomes in randomi zed clinical trials and that we design interventions to optimize change in the mediators of interest. Yet, knowledge of the pivotal mediating variable s in behavior change does not imply that we know how to inter:ene effective ly. This gap may be due to the fact that existing research typically has be en designed to garner support for theory, as opposed to testing support for behavior change strategies that are based on theory. In addition, we argue that there are important mediating variables in behavior change that have not been given systematic attention in theory development. For example, beh avior change must be viewed as a collaborative process, and participants' p erceptions concerning the feasibility of change is important to motivationa l processes in randomized clinical trials. Control Clin Trials 2000;21:164S -170S (C) Elsevier Science Inc. 2000.