Kimel Family Centre for Brain Health and Wellness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Interleukin-6
研究概览
简要总结
Participants (n=450; aged 50+; without a diagnosis of dementia; sufficiently fluent in English to complete the assessments and engage in programming) receive a comprehensive dementia risk assessment, including nonmodifiable and modifiable risk factors, from which they receive a Personalized Dementia Risk Report and Program Strategy, indicating their health conditions increasing and their risk level in five modifiable risk domains: physical activity, brain- healthy eating, cognitive engagement, social connections, and mental wellbeing. Equipped with this information, participants enroll in programs within the Centre to address their risk factors. Changes to their dementia risk, cognition, and Personalized Program Strategy are communicated through re-assessments of risk factors every six months (risk and cognition) and every year (comprehensive assessment).
详细描述
Participants (n=450; aged 50+; without a diagnosis of dementia; sufficiently fluent in English to complete the assessments and engage in programming) complete a baseline assessment consisting of three parts. A biosample session in which blood is drawn to measure HbA1c, cholesterols, thyroid levels, c-reactive protein, interleukin-6, homocysteine, and BDNF, and a saliva sample is provided to provide a polygenic risk score for AD. A questionnaire session is completed on a tablet or from home asks about demographics, health conditions, and five targeted modifiable factors: physical activity, brain-healthy eating, cognitive engagement, social connections, and mental wellbeing. A clinical session measures vitals, sensory function, frailty markers (grip strength, DXA, ultrasound of right quadriceps muscle), dual-task gait, and cognition (MoCA and Cogniciti's Brain Health Assessment). From that assessment, participants receive a Personalized Dementia Risk Report and Program Strategy, outlining conditions that are known to increase dementia risk, with resources provided on how to get them addressed, as well as their risk level in the five targeted domains. Participants then take a SMART goal setting workshop to identify SMART goals addressing their dementia risk factors, and then sign up for programming in the centre to reduce their risk. After six months, their risk in the five targeted domains, cognition (Brain Health Assessment), and satisfaction are re-assessed, and every year, most of the baseline assessment is repeated. We expect that this personalized approach will result in reductions in risk in the five targeted domains within the first six months, improvements in health factors within the first year, and improvements in cognition within two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 50 years or older
- •Sufficiently fluent in English to complete the assessments and participate in programming.
排除标准
- •Diagnosis of dementia.
结局指标
主要结局
Interleukin-6
时间窗: Every year over two years.
Interleukin-6, assessed via blood draw, where lower numbers indicate less inflammation.
HbA1c
时间窗: Every year over two years.
Hemoglobin A1C (HbA1c), measured through blood draw, where lower numbers indicate less blood sugar.
Physical Activity
时间窗: Every six months over two years.
Hours of moderate-to-vigorous physical activity a week, as determined by the CHAMPS (0 - 168, with higher scores indicating greater activity).
Cognition
时间窗: Every six months over two years.
Cognition, assessed as an age- and sex-adjusted percentile on the Brain Health Assessment (an online cognitive assessment of episodic memory, working memory, and executive functioning).
Brain-Healthy Eating
时间窗: Every six months over two years.
Brain-healthy eating as assessed by the Brain Health Food Guide derived Eating Pattern Self-Assessment (range 0 - 15, with higher scores indicating greater adherence to the Brain Health Food Guide).
Cognitive Engagement
时间窗: Every six months over two years.
Amount of engagement in higher-order cognitively engaging activities, as assessed by the Higher Cognition subscale of the Florida Cognitive Activities Scale (range 0-40, with higher scores indicated greater engagement).
Social Connections
时间窗: Every six months over two years.
Degree of loneliness as assessed by the UCLA Loneliness Scale (Version 3; range = 0-80, where higher scores indicate greater loneliness).
Mental Wellbeing
时间窗: Every six months over two years.
A composite of depression, anxiety, and (dis)stress from the Depression, Anxiety, and Stress Scale-21 (DASS-21), as well as perceived stress from the Perceived Stress Scale (with each subscale converted to a percentage of maximum and summed; range: 0 - 400).
Diastolic Blood Pressure
时间窗: Every year over two years.
Diastolic Blood Pressure, which lower numbers indicated better blood pressure.
Systolic Blood Pressure
时间窗: Every year over two years.
Systolic Blood Pressure, where lower numbers indicate better blood pressure
Percent body fat
时间窗: Every year over two years.
Percent body fat as determined by dual-energy X-ray absorptiometry (DXA), where lower numbers indicate less body fat.
Low density lipoprotein
时间窗: Every year over two years.
Low density lipoprotein, assessed via blood draw, where lower numbers indicate less cholesterol.
C-reactive protein
时间窗: Every year over two years.
C-reactive protein, assessed via blood draw, where lower numbers indicate less inflammation.
次要结局
未报告次要终点