A Critical Review and User’s Guide for Conducting Feasibility and Pilot Studies in the Physical Activity Domain

IALH Research Fellows Sam Liu, Ryan Rhodes and IALH Student Affiliate Heather Hollman have co-authored a new research article entitled A Critical Review and User’s Guide for Conducting Feasibility and Pilot Studies in the Physical Activity Domain. Collaborating authors include Margie Davenport. The article was published in American Psychological Association.

Abstract: Feasibility/pilot studies should be conducted prior to larger scale randomized controlled trials (RCTs) in physical activity (PA) intervention research. There have been changes in recommendations for feasibility/pilot studies over the years, leading to a crowded and inconsistent landscape of methodologies. The purpose of this article is to critically review up-to-date feasibility/pilot study methodological recommendations and provide a user’s guide for PA researchers. We searched five databases for articles that described feasibility/pilot study methodological recommendations and identified 54 articles. We critically analyzed five areas with notable controversy and advancements. First, terminology has been inconsistent; however, the Consolidated Standards of Reporting Trials extension places pilot studies as a subset of feasibility studies. Second, there has been an evolving development of methodological recommendations. Third, sample sizes often are not justified, limiting their capacity to inform valid predictions. Fourth, preliminary results of clinical or behavioral outcomes can substantially over- or underestimate effect sizes in larger RCTs. Finally, decision processes for scaling up, although fundamental, often are not described. We recommend the following step-by-step guide to plan, conduct, and report randomized feasibility/pilot trials: (a) design a study protocol that follows Consolidated Standards of Reporting Trials guidelines and have an evidence-based theoretically informed intervention, (b) choose process criteria and indicators of success, (c) justify the sample size, (d) thoroughly document process outcomes, (e) analyze with descriptive statistics, and (f) review all process criteria outcomes to determine next steps. This guide should help to minimize misconceptions in the PA literature and optimize future RCTs that have the greatest potential for demonstrating treatment effects. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

To read the full article, see https://psycnet.apa.org/doi/10.1037/spy0000350