The INIT Lab has been collaborating with Dr. Kathryn M. Ross at UF in the Department of Clinical & Health Psychology on a clinical trial of an mHealth app for supporting weight loss and weight loss maintenance (for more, see our Project STAR and MyTrack+ project write-ups). During the COVID-19 pandemic, our research, like those of many other labs around the world, was affected by the need to avoid in-person human subjects research activity. We transitioned our clinical cohorts to remote delivery of the intervention without loss of adherence or efficacy, and published our process, insights, and lessons learned in a recent Obesity journal article.
The paper’s abstract is as follows:
This study evaluated whether the transition of a face-to-face behavioral intervention to videoconferencing-based telehealth delivery during the COVID-19 pandemic resulted in significantly smaller weight losses than those typically observed in gold-standard, face-to-face programs. Participants were 160 adults with obesity (mean [SD] age = 49.2 [11.9] years, BMI = 36.1 [4.2] kg/m2) enrolled in two cohorts of a 16-week comprehensive weight-management program. Cohort 1 began in person and transitioned to telehealth (Zoom) delivery during week 11 of the intervention because of COVID-19; Cohort 2 was conducted completely remotely. A noninferiority approach (using a clinically relevant noninferiority margin of 2.5%) was used to assess whether the weight losses observed were inferior to the 8% losses from baseline typically produced by gold-standard, face-to-face lifestyle interventions. From baseline to postintervention, participants lost an average of 7.4 [4.9] kg, representing a reduction of 7.2% [4.6%]. This magnitude of weight change was significantly greater than 5.5% (t[159] = 4.7, p < 0.001), and, thus, was within the proposed noninferiority margin. These findings demonstrate that the results of behavioral weight-management interventions are robust, whether delivered in person or remotely, and that individuals can achieve clinically meaningful benefits from behavioral treatment even during a global pandemic. Pragmatic “lessons learned,” including modified trial recruitment techniques, are discussed.
The preprint of this article will be available soon on our Publications page, and the final version is already available on the journal’s site. In fact, the results from running these cohorts remotely were so positive, as well as allowing us to reach a broader audience with our recruiting, that even after it was deemed safe enough to return to in-person research activities, we have opted to run the remaining cohorts virtually. We think these insights gained through this necessary adaptation process will also help us with deployment of mHealth interventions more broadly to, for example, patients with less access to in-person healthcare. Stay tuned for more on this project!