The BASIC-S Feasibility Study for Vascular Risk Reduction
BASIC-S
Piloting an Integrated Lifestyle Intervention for Vascular Risk Reduction: The BASIC-S Feasibility Study
2 other identifiers
interventional
120
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2026
CompletedFirst Posted
Study publicly available on registry
August 10, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
Study Completion
Last participant's last visit for all outcomes
October 1, 2027
August 10, 2026
August 1, 2026
9 months
August 5, 2026
August 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Recruitment Rate
Feasibility operationalized as the proportion of eligible individuals approached who consent to enroll in the trial.
At the conclusion of the 5-month recruitment period.
Retention Rate
Feasibility operationalized as the proportion of enrolled participants who complete the final 6-month follow-up assessment.
At 6 months post-randomization.
Secondary Outcomes (5)
Change in Integral Brain Health (IBH) Index Score
Baseline, 3 Months, 6 Months.
Change in BASIC-S Implementation Index Score
Baseline, 3 Months, 6 Months.
Change in Systolic Blood Pressure
Baseline, 3 Months, 6 Months.
Convergent Validity of Novel Indices
Baseline and 6 Months.
Intervention Acceptability
At 6 months post-randomization.
Study Arms (2)
BASIC-S Intervention Group
EXPERIMENTALHouseholds allocated to this arm receive a multicomponent behavioral lifestyle program grounded in the Information-Motivation-Behavioral Skills (IMB) model.
Standard Care (Usual Care) Group
ACTIVE COMPARATORHouseholds allocated to this arm receive pure usual care to serve as a real-world comparator, continuing their routine healthcare and access to institutional wellness resources.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
- Spouse or cohabitating partner of an enrolled primary participant (partner enrollment is optional but strongly encouraged).
- Capable of providing informed consent.
- Access to a mobile device capable of receiving short message service (SMS) communications and viewing PDF documents.
- Physical ability to perform light-to-moderate physical activity.
You may not qualify if:
- Medical conditions precluding safe exercise (e.g., unstable angina, uncontrolled arrhythmia, severe heart failure) without physician clearance.
- Active or unstable psychiatric conditions, defined as hospitalization for psychiatric care within the preceding 6 months or modifications to antipsychotic or mood-stabilizing pharmacotherapy within the preceding 3 months. (Note: Participants with stable, medically managed psychiatric conditions remain eligible).
- Severe cognitive impairment preventing the ability to consent or use study technology.
- Inability to read and understand English.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre (LHSC)
London, Ontario, N6A 3K7, Canada
Related Publications (3)
Avan A, Hachinski V. Global, regional, and national trends of dementia incidence and risk factors, 1990-2019: A Global Burden of Disease study. Alzheimers Dement. 2023 Apr;19(4):1281-1291. doi: 10.1002/alz.12764. Epub 2022 Aug 31.
PMID: 36044376BACKGROUNDHachinski V. Brain Health-Curbing Stroke, Heart Disease, and Dementia: The 2020 Wartenberg Lecture. Neurology. 2021 Aug 10;97(6):273-279. doi: 10.1212/WNL.0000000000012103. Epub 2021 Apr 21.
PMID: 33883239BACKGROUNDAvan A, Andersen R, Andersson N, Frisbee SJ, Singh S, Zhong S, Rogers KA, Whitehead SN, Hachinski V. An operational measurement of brain health: the ABCDS framework. Lancet Neurol. 2025 Apr;24(4):291-292. doi: 10.1016/S1474-4422(25)00076-6. No abstract available.
PMID: 40120612BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
August 5, 2026
First Posted
August 10, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
August 10, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will become available beginning 9 months and ending 36 months following article publication.
- Access Criteria
- Data access requests will be reviewed by the Principal Investigator and the study steering committee. Requestors must provide a formal research proposal and statistical analysis plan. To protect the privacy of this occupational cohort, access will require a formal Data Sharing Agreement (DSA) approved by the London Health Sciences Centre Research Institute (LHSCRI) contracts office. Proposals should be directed to the Principal Investigator at andrew.appleton@lhsc.on.ca.
De-identified individual participant data (IPD) collected during the trial will be made available to qualified researchers who provide a methodologically sound proposal to achieve aims outlined in the approved proposal.