Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Maintain Your Brain Online Cognitive Test Battery-Change |
These are standard cognitive tests in three domains: attention, executive function, and learning/memory. individual test scores will be converted to standard scores using the means and standard deviations (SDs) of the study population. Tests within each domain will be averaged to create domain scores, and the three domain scores will then be averaged to create a single global composite score. Cognitive scores are standardized, mean=0, SD=1, expected range: -6 to +6 , highest score reflects the better outcome. |
Baseline and 3 months |
|
| Primary |
Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF) |
This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. It includes items related to demographics (age, sex, education), obesity, diabetes, hypercholesterolemia, head injury, depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, pesticide exposure, and fish intake. Test scores with be combines to create a single global composite score. Cognitive scores are standardized, mean=0, SD=1, expected range: -6 to +6 , highest score reflects the better outcome. |
Baseline and 3 months |
|
| Secondary |
Physical activity-Change |
ANU-ADRI-SF assesses physical activity using the using the validated International Physical Activity Questionnaire short form. Participants are asked about time spent (days/week, minutes/day) doing vigorous physical activity, moderate physical activity, walking and sitting in the past 7 days, and responses are converted into metabolic equivalents per week. ANU-ADRI-SF - change range = -94 to +94, lower scores reflect the best outcome. |
Baseline and 3 months |
|
| Secondary |
Depression-Change |
ANU-ADRI-SF assesses depressive symptoms using the validated 10-item version of the Center for Epidemiologic Studies-Depression Scale (CES-D). Participants are asked about feelings in the past week with response categories of 0 (<1/day), 1 (1-2 days), 2 (3-4 days) or 3 (5-7 days). Scores may range from 0 to 30, with higher scores indicating more depressive symptoms. NU-ADRI-SF - change range = -94 to +94, lower scores reflect the best outcome. |
Baseline and 3 months |
|
| Secondary |
Loneliness / social isolation-Change |
The investigators will measure loneliness / social isolation using the validated measure 3-item UCLA Loneliness Scale, which consists of 3 items (lack companionship, feel left out, feel isolated) that are rated as 1 (hardly ever), 2 (some of the time), or 3 (often). Scores may range from 3 to 9, with higher scores reflecting greater loneliness. |
Baseline and 3 months |
|
| Secondary |
Emotional well-being-Change |
Neuro-QOL v1.0 Positive Affect and Well-Being Short Form, which includes 9 items (e.g. sense of well-being, feeling hopeful, life was satisfying, etc.) with 5-point responses from never (1) to always (5). Scores may range from 9 to 45, with higher scores reflecting greater feelings of well-being. |
Baseline and 3 months |
|
| Secondary |
Mind-body awareness-Change |
The investigators will measure mind-body awareness using the self-regulation sub-scale of the validated Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2). The self-regulation sub-scale includes 4 items rated on a six-point Likert scale (0/never to 5/always) about the ability to regulate distress by paying attention to bodily sensations (e.g., "When I feel overwhelmed I can find a calm place inside.") Scores reflect the mean of responses (range 0 to 5), with higher scores indicating greater self-regulation. |
Baseline and 3 months |
|
| Secondary |
Diet-Change |
The investigators will measure diet using the validated MIND diet score. The MIND diet is a hybrid of the Mediterranean and DASH (Dietary Approaches to Stop Hypertension) diets. It has 15 dietary components including 10 brain healthy foods (e.g., green leafy vegetables, berries) and 5 less healthy foods (e.g., red meat, fried/fast foods). The frequency of consumption for each item is scored as 0, 0.5 or 1, and the total MIND diet score is calculated by summing over the 15 components. Scores may range from 0 to 15, with higher scores reflecting better adherence to the MIND diet. |
Baseline and 3 months |
|
| Secondary |
Obesity/weight-Change |
ANU-ADRI-SF includes questions about self-reported height and weight, which will be used to calculate body mass index (BMI). NU-ADRI-SF - change range = -94 to +94, lower scores reflect the best outcome. |
Baseline and 3 months |
|
| Secondary |
Sleep-Change |
PROMIS Sleep Disturbance Short Form 4-item measure. The Investigators will measure sleep disturbance using the validated PROMIS Sleep Disturbance Short Form 4-item measure which asks about sleep quality and disturbance in the past 7 days on a 5-point Likert scale. Scores may range from 4 to 20 which higher scores indicating more sleep disturbance. In addition, we will include a single item from the Pittsburgh Sleep Quality Index on hours of sleep per night in the past month. |
Baseline and 3 months |
|
| Secondary |
Self-efficacy/Confidence-Change |
Self-Efficacy for Managing Chronic Disease 6-item scale to measure self-efficacy for engaging in activities to support brain health. Each item is rated on an 11-point Likert scale from 0 (not at all confident) to 10 (totally confident). The score is the mean of the 6 items with higher scores reflecting higher self-efficacy. |
Baseline and 3 months |
|
| Secondary |
Cognitive activity-Change |
Cognitive Activity Questionnaire (CAQ). The investigators will measure engagement in cognitive stimulating activities using a validated measure such as the Cognitive Activity Questionnaire (CAQ). The CAQ includes 11 items that ask how often individuals engage in various cognitive activities such as reading or playing games on a 6-point Likert scale (once a month/never to every day). |
Baseline and 3 months |
|
| Secondary |
Alcohol-Change |
The investigators will measure alcohol consumption using 2 items in the ANU-ADRI that ask about frequency and amount of alcohol consumption. |
Baseline and 3 months |
|
| Secondary |
Smoking-Change |
The investigators will assess smoking with standard questions about tobacco use ever and during the past 7 days |
Baseline and 3 months |
|
| Secondary |
Global quality of life-Change |
The investigators will measure global quality of life using the validated PROMIS Scale v1.2 - Global Health. This scale includes 10 items rated on a 5-point Likert scale from 1 (poor) to 5 (excellent) and includes questions about overall self-rated health, overall quality of life, physical health, mental health, social relationships, fatigue and pain. |
Baseline and 3 months |
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