Feasibility indicators in obesity-related behavioral intervention preliminary studies: A historical scoping review
Christopher D Pfledderer, Lauren von Klinggraeff, Sarah Burkart, Luke Wolfenden, John P.A. Ioannidis, Michael W. Beets
Background: Behavioral interventions are often complex, operate at multiple levels, across settings, and employ a range of behavior change techniques. Collecting and reporting key indicators of initial trial and intervention feasibility is essential to decisions for progressing to larger-scale trials. The extent of reporting on feasibility indicators and how this may have changed over time is unknown. The aims of this study were to: 1) conduct a historical scoping review of the reporting of
... ibility indicators in behavioral pilot/feasibility studies related to obesity published through 2020, and 2) describe trends in the amount and type of feasibility indicators reported in studies published across three time periods: 1982-2006, 2011-2013, and 2018-2020.Methods: A search of online databases (PubMed, Embase, EBSCOhost, Web of Science) for health behavior pilot/feasibility studies related to obesity published up to 12/31/2020 was conducted and a random sample of 600 studies, 200 from each of the three timepoints (1982-2006, 2011-2013, and 2018-2020) was included in this review. The presence/absence of feasibility indicators, including recruitment, retention, participant acceptability, attendance, compliance, and fidelity, were identified/coded for each study. Univariate logistic regression models were employed to assess changes in the reporting of feasibility indicators across time.Results: A total of 16,365 unique articles were identified of which 6,873 of these were reviewed to arrive at the final sample of 600 studies. For the total sample, 428 (71.3%) studies provided recruitment information, 595 (99.2%) provided retention information, 219 (36.5%) reported quantitative acceptability outcomes, 157 (26.2%) reported qualitative acceptability outcomes, 199 (33.2%) reported attendance, 187 (31.2%) reported participant compliance, 23 (3.8%) reported cost information, and 85 (14.2%) reported treatment fidelity outcomes. When compared to the Early Group (1982-2006), studies in the Late Group (2018-2020) were more likely to report recruitment information (OR=1.60, 95%CI:1.03-2.49), acceptability-related quantitative (OR=2.68, 95%CI:1.76-4.08) and qualitative (OR=2.32, 95%CI:1.48-3.65) outcomes, compliance outcomes (OR=2.29, 95%CI:1.49-3.52), and fidelity outcomes (OR=2.13, 95%CI:1.21, 3.77).Conclusion: The reporting of feasibility indicators within behavioral pilot/feasibility studies has improved across time, but key aspects of feasibility, such as fidelity, are still not reported in the majority of studies. Given the importance of behavioral intervention pilot/feasibility studies in the translational science spectrum, there is a need for improving the reporting of feasibility indicators.