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NOT YET RECRUITING
NCT07755631
NA

The BASIC-S Feasibility Study for Vascular Risk Reduction

Sponsor: Andrew Appleton

View on ClinicalTrials.gov

Summary

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.

Official title: Piloting an Integrated Lifestyle Intervention for Vascular Risk Reduction: The BASIC-S Feasibility Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-10-01

Completion Date

2027-10-01

Last Updated

2026-08-25

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

BASIC-S Intervention

Participants attend an initial 45-minute goal-setting session with a certified wellness coach. Subsequent support includes an interactive BASIC-S Digital Workbook, automated twice-weekly motivational and educational SMS messages via Twilio, and biweekly (every two weeks) 15-20 minute face-to-face secure video booster sessions (via Microsoft Teams) using motivational interviewing. Intervention households receive a validated automated home blood pressure monitor at baseline.

BEHAVIORAL

Standard / Usual Care

Participants are instructed to continue routine medical follow-up as directed by their primary care providers. To serve as a true comparator, no study-specific behavioral prompts or educational materials are provided during the active 6-month study period. To maximize ethical benefit (waitlist control), control households receive the complete BASIC-S Digital Workbook and a validated automated home blood pressure monitor at the conclusion of their 6-month follow-up visit.

Locations (1)

London Health Sciences Centre (LHSC)

London, Ontario, Canada