The BASIC-S Feasibility Study for Vascular Risk Reduction

Overview

Vascular risk factors drive stroke, heart disease, and dementia, but translating lifestyle guidelines into routine clinical care remains challenging. To address this, we developed BASIC-S (Blood Pressure, Activity, Sleep, Interaction, Consumption, and Support), a framework targeting Blood pressure, Activity, Sleep, Interaction (socially), Consumption (nutrition), and Support using partner support and motivational interviewing. This individual-focused approach bypasses the logistical and financial barriers of complex clinical interventions by using sustained behavioral science to support gradual lifestyle changes. This study is a single-center, mixed-methods, cluster-randomized pilot trial evaluating the feasibility of the BASIC-S protocol in an occupational setting. A maximum of 60 households (120 participants) will be randomized 1:1 to either the BASIC-S intervention (motivational coaching, secure video check-ins, automated text messages, and a digital workbook) or standard care. Outcomes will assess feasibility, acceptability, and the validity of new tracking metrics to inform a future full-scale trial.

Background and Rationale: High blood pressure, inactivity, poor sleep, social isolation, and unhealthy diets drive stroke, heart disease, and dementia. As dementia rates plateau and cardiovascular diseases rise, current public health strategies are stalling. The 2025 Hypertension Canada guidelines lowered the threshold for hypertension to 130/80 mm Hg (target \<130 mm Hg), vastly increasing the population needing management. However, translating lifestyle risk reduction into routine care is hindered by fragmented clinical workflows and a lack of behavioral support. To address this, we developed BASIC-S (Blood Pressure, Activity, Sleep, Interaction, Consumption, and Support) framework. Grounded in partnering and motivational interviewing principles, BASIC-S is designed to bridge the evidence-to-practice implementation gap and support the translation of research into real-world health behavior change. Study Design and Setting: This study is a single-center, mixed-methods, cluster-randomized pilot trial conducted at the London Health Sciences Centre (LHSC). Randomization occurs at the household level, enrolling either individual employees or employee-partner pairs. Households are randomized 1:1 to either the BASIC-S intervention or standard care for six months. Statistical Analysis Plan: Analyses will be conducted at the individual participant level, with the primary timepoint for comparison being 6 months. To account for the potential clustering effects of households, continuous outcome data will be analyzed using mixed models for repeated measures, incorporating a random intercept for the household. Sensitivity to the normality assumptions of continuous outcomes will be assessed using rank-based methods designed for cluster-randomized trials. Discrete outcomes will be evaluated using a generalized estimating equations (GEE) approach alongside applicable rank-based methods. The standard deviation of the change scores and the intraclass correlation coefficient (ICC) will be estimated to inform power calculations for the future definitive trial. To assess convergent validity, correlation coefficients (e.g., Pearson or Spearman) will be calculated between the novel indices and established psychometric reference scales. Qualitative transcripts will undergo thematic analysis by two independent coders to systematically classify barriers, facilitators, and overall acceptability.