Results of a pilot randomized controlled trial of a COM-B-based physical activity behavior-change intervention in...

This pilot randomized controlled trial (RCT) evaluated the efficacy of a behavioral intervention grounded in the Capability-Opportunity-Motivation-Behavior (COM-B) model delivered via online coaching and newsletters for promoting physical activity (PA) in people newly diagnosed with multiple sclerosis (PNDwMS).

This unblinded, parallel-group, RCT included 50 PNDwMS (disease duration ≤ 2 years) who were randomized into either PA intervention (n = 25) or waitlist control (WLC) (n = 25) conditions. The intervention was delivered over 16 weeks by a researcher uninvolved in randomization. Data were collected pre- and post-intervention. Primary outcomes included device-measured (steps/day, light PA [LPA], moderate-to-vigorous PA [MVPA]) and self-reported PA (Godin Leisure-Time Exercise Questionnaire [GLTEQ] and International Physical Activity Questionnaire [IPAQ]). Secondary outcomes included fatigue, depression, anxiety, and health-related quality of life (HRQOL). Data were analyzed (intent-to-treat) using condition-by-time mixed-effects ANOVA.

There were significant condition-by-time interactions on device-measured (MVPA) and self-reported (IPAQ) PA as well as depression and mental HRQOL (all p ≤ .05). There were moderate and significant improvements in MVPA (Δ11.2 min/day, 95% CI: 8.8, 13.7, d = 0.5) and IPAQ (Δ11.4 units, 95% CI: 10.4, 12.3, d = 0.7), HADS-D (Δ1.4 units, 95% CI: 1.3, 1.5, d = 0.5), and SF-12 MCS (Δ5.6 units, 95% CI: 5.1, 6.1, d = 0.6) scores in the PA intervention condition, but not in the WLC condition.

These findings provide preliminary evidence for the efficacy of the COM-B-based behavioral intervention for increasing PA and improving mental health outcomes in PNDwMS.