Piloting an Integrated Lifestyle Intervention for Vascular Risk Reduction: The BASIC-S Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •Has access to a mobile device capable of receiving Short Message Service (SMS) communications and viewing Portable Document Format (PDF) documents.
- •Physically able to safely engage in light-to-moderate intensity physical activity.
排除标准
- •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.
研究组 & 干预措施
BASIC-S Intervention Group
Households allocated to this arm receive a multicomponent behavioral lifestyle program grounded in the Information-Motivation-Behavioral Skills (IMB) model.
干预措施: BASIC-S Intervention (Behavioral)
Standard Care (Usual Care) Group
Households 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.
干预措施: Standard / Usual Care (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: At the conclusion of the 5-month recruitment period.
Feasibility operationalized as the proportion of eligible individuals approached who consent to enroll in the trial.
Retention Rate
时间窗: At 6 months post-randomization.
Feasibility operationalized as the proportion of enrolled participants who complete the final 6-month follow-up assessment.
次要结局
- 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.)
- Convergent Validity of Novel Indices(Baseline and 6 Months.)
- Change in Systolic Blood Pressure(Baseline, 3 Months, 6 Months.)
- Intervention Acceptability(At 6 months post-randomization.)
- Change in Subjective Well-Being (WHO-5)(Baseline and 6 Months.)
- Change in Subjective Cognitive Function (PROMIS)(Baseline and 6 Months)
- Change in Sleep Disturbance (PROMIS)(Baseline and 6 Months)
- Change in Physical Activity (PAVS)(Baseline and 6 Months)
- Change in Social Connectivity (LSNS-6)(Baseline and 6 Months)
- Change in Dietary Quality (STC)(Baseline and 6 Months)
研究者
Andrew Appleton
LHSC-University Hospital (LHSC-UH) Site Chief, Associate Professor, Deputy Program Director for the Department of Medicine (DOM) Internal Medicine (IM4) Program, Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's