Feasibility of online behavioral clinical trials: The future of weight management randomized clinical trials?

Abstract

Behavioral weight management trials are traditionally conducted in-person. The COVID-19 shutdown halted in-person operations, forcing investigators to develop new methods for remote treatment and assessment delivery without additional funding for website development or remote equipment. This study examined the feasibility and acceptability of remote procedures from an ongoing weight management trial impacted by COVID-19. Using a quasi-experimental longitudinal design, in-person (pre-COVID) and remote (COVID) treatment and assessment procedures were used. Attendance at in-person versus remote (videoconference) treatment sessions was compared. Acceptability of treatment modalities (in-person vs. remote) was examined via self-report. Validity and reliability were assessed on bathroom scales. Attendance at remote (videoconference+mailed, scales) versus in-person assessment sessions was compared. Finally, exploratory analyses were conducted to determine whether participant characteristics moderated the effects. Remote treatment attendance was significantly better than in-person. Overall, there was no significant difference in modality preference. However, Hispanic (vs. non-Hispanic) individuals had greater preference for remote options and attended more remote treatment sessions. Bathroom scales demonstrated excellent validity and reliability. Adherence to remote and in-person assessment sessions was similar. COVID-19 has provided an opportunity to rethink how we conduct research. Results herein establish an evidence-base to support a paradigm shift to remote clinical trial procedures. Such a shift may enhance diversity in clinical trials.