The BASIC-S Feasibility Study for Vascular Risk Reduction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAndrew Appleton

About this trial

Vascular risk factors drive stroke, heart disease, and dementia, but translating lifestyle guidelines into routine clinical care remains challenging. To address this, we developed the BASIC-S 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.

Eligibility criteria

Qualifiers

Adults aged 18 years and older currently employed at or recently retired from the London Health Sciences Centre (LHSC) or Western University (with an operational focus on pre-retirees aged 50 years and older).

The primary applicant (not their partner, if applicable) must be within two years before or after their retirement date.

Spouse or cohabitating partner of an enrolled primary participant. Cohabitating partners may include a common-law partner, adult child, close friend, or roommate who lives with the primary participant and shares common health goals. Enrollment of partners is optional but strongly encouraged.

Capable of providing informed consent.

Disqualifiers

Medical conditions that preclude safe participation in physical activity (for instance, unstable angina, uncontrolled arrhythmia, severe heart failure) without physician clearance.

Active or unstable psychiatric illness, defined as hospitalization for psychiatric care within the preceding 6 months or modifications to antipsychotic or mood-stabilizing pharmacotherapy within the preceding 3 months. Participants with stable, medically managed psychiatric conditions remain eligible.

Severe cognitive impairment that compromises the ability to provide informed consent or independently use study-related technology.

Inability to read and understand English sufficiently to provide informed consent and complete study procedures.

Trial design

Treatments tested in this trial

  • BASIC-S Intervention
  • Standard / Usual Care

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Andrew Appleton

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Sponsor institution

Academic Medical Organization of Southwestern Ontario

Collaborator