Abstract
Background and Objectives Evidence of effective multifactorial lifestyle interventions for primary stroke prevention is lacking, despite the significant contribution of lifestyle to stroke burden. We aimed to determine the efficacy of health and wellness coaching (HWC) for primary stroke and cardiovascular disease (CVD) prevention in adults at a moderate-to-high CVD risk.Methods This was a parallel, 2-arm, open-label, single-blinded, phase III randomized controlled trial to determine the efficacy of HWC for primary stroke prevention in individuals 30 years and older with a 5-year CVD risk >= 10% as measured by 5-year absolute CVD risk (as measured by the PREDICT tool) at 9 months post-randomization. Eligible participants were those with a 5-year CVD risk >= 10%, with no history of stroke, transient ischemic attack, or myocardial infarction. The relative risk reduction (RRR) and odds ratios (OR) were evaluated separately in those at moderate (10%-14%) 5-year CVD risk and those at high risk (>= 15%) at baseline. The Life's Simple 7 (LS7) score for lifestyle-related CVD risk, as the indicator of cardiovascular health, was a key secondary outcome.Results Of a total of 320 participants, 161 were randomized to the HWC group and 159 to the usual care (UC) group. HWC resulted in a statistically significant RRR of -10.9 (95% CI -21.0 to -0.9) in 5-year CVD risk in the higher CVD risk group but no change in the moderate risk group. An improvement in the total LS7 score was seen in the HWC group compared with the UC group (absolute difference = 0.485, 95% CI [0.073 to 0.897], p = 0.02). Improvement in blood pressure scores was statistically significantly greater in the HWC group than in the UC group for those at high risk of CVD (OR 2.28 [95% CI 1.12 to 4.63] and 1.55 [0.80 to 3.01], respectively). No statistically significant differences in mood scores, medication adherence, quality of life, and satisfaction with life scores over time or between groups were seen.Discussion Health and wellness coaching resulted in a significant RRR in the 5-year CVD risk compared with UC at 9 months post-randomization in patients with a high baseline CVD risk. There was no improvement in CVD risk in the moderate risk group; hence, this study did not meet the primary hypothesis. However, this treatment effect is clinically significant (number needed to treat was 43). The findings suggest that HWC has potential if further refined to improve lifestyle risk factors of stroke.