An interventional study of Brain Health Academy and Brain Health Together in Mild Cognitive Impairment, Cognitive Decline and Cognitive Deterioration, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
The purpose of this study is to develop and test a comprehensive Brain Health Together program for older adults living with cognitive decline.
Older adults with cognitive decline (including either mild cognitive impairment [MCI] or subjective cognitive decline [SCD]) represent a large market with important unmet needs. Approximately one in three older adults (18 million Americans) are currently living with cognitive decline, which places them at increased risk of developing Alzheimer's disease and related dementias (ADRD). There are no medications that can prevent development of dementia in people with cognitive decline; however, there is growing evidence that behavioral interventions targeting modifiable dementia risk factors-such as increasing physical activity and reducing social isolation-may help improve cognitive function and could potentially delay dementia onset. Preliminary results suggest that Moving TogetherTM program is associated with significant improvements in cognitive function, physical function, social isolation, and self-regulation as well as increased default mode network connectivity on pre/post resting state functional magnetic resonance imaging scans in people with cognitive decline. The investigators believe that these benefits would be even greater if Moving Together were combined with a comprehensive brain health coaching program.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 208 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
Candidates meeting any of the exclusion criteria will not be eligible to participate.
Alzheimer's disease or dementia
- Major neurological disorder (e.g., Parkinson's disease, Multiple Sclerosis, amyotrophic Lateral Sclerosis)
If participants are not sure about certain conditions, they will be asked to describe their condition, and the research team will determine whether they meet eligibility criteria or not.
Participants in this arm will watch expert videos on a wide range of brain health topics and will complete quizzes for 2.5 hours a week for 12 weeks (30 hours total)
Behavioral: Brain Health Academy
Participants in this arm will participate in online, live-streaming Moving Together classes (1 hour a week) and group brain health classes (1 hour a week) and will work 1-on-1 with a brain health coach to set personalized risk reduction goals (0.5 hours a week) for 12 weeks (30 hours total)
Behavioral: Brain Health Together
Participants in this arm will participate in the full Brain Health Together program for 12 weeks (30 hours) followed by weekly group classes and six 1-on-1 coaching sessions for another 12 weeks (additional 15 hours; 45 hours total)
Behavioral: Maintain Brain Health Together
The Brain Health Academy group will review online content about brain health (1 hour, 2 days/week for 12 weeks) and will complete a brief survey after each module to assess compliance (30 hours total).
The Brain Health Together group will participate in online, live-streaming, group-based Moving Together classes (1 hour/week); Brain Health education group classes (1 hour/week) and individual brain health coaching sessions (0.5 hours/week) for 12 weeks (30 hours total).
The Maintaining Brain Health Together group will participate in the full Brain Health Together program (30 hours) for 12 weeks followed by weekly group classes and six individual coaching for an additional 12 weeks (additional 15 hours).
Creyos Cognitive Composite - 3 Month
The Creyos online cognitive test battery included digit span, feature match, grammatical reasoning, paired associates, and token search. We converted raw scores to standardized z scores for each test using the group baseline mean and standard deviation. We then summed the standardized scores to create a composite cognitive score and re-standardized the composite score using the group baseline mean and standard deviation (baseline mean=0, SD=1). Positive change reflects improved cognitive performance.
Time frame: Baseline to 3 months
Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF) - 3 Month Change
This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. We created a modified version that only included risk factors that are modifiable and targeted by our intervention (depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, and fish intake) using the weights from the original score. We then converted the calculated score to a z score using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased dementia risk; negative scores reflect reduced dementia risk.
Time frame: Baseline to 3 months
Creyos Cognitive Composite - 6 Month Change
The Creyos online cognitive test battery included digit span, feature match, grammatical reasoning, paired associates, and token search. We converted raw scores to standardized z scores for each test using the group baseline mean and standard deviation. We then summed the standardized scores to create a composite cognitive score and re-standardized the composite score using the group baseline mean and standard deviation (baseline mean=0, SD=1). Positive change reflects improved cognitive performance.
Time frame: Baseline to 6 months
Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF) - 6 Month Change
This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. We created a modified version that only included risk factors that are modifiable and targeted by our intervention (depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, and fish intake) using the weights from the original score. We then converted the calculated score to a z-score using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased dementia risk; negative scores reflect reduced dementia risk.
Time frame: Baseline to 6 months
Loneliness / Social Isolation - 3 Month Change
Loneliness / social isolation was measured using the validated 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. Raw scores were converted to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased loneliness, negative change scores reflect decreased loneliness.
Time frame: Baseline to 3 months
Depression - 3 Month Change
We assessed 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. We concerted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased depressive symptoms; negative change scores reflect reduced depressive symptoms.
Time frame: Baseline to 3 months
Cognitive Activity - 3 Month Change
We measured engagement in cognitive stimulating activities using the validated 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). Higher scores reflect more cognitive activity. We converted raw scores to standardized z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased cognitive activity; negative change scores reflect reduced cognitive activity.
Time frame: Baseline and 3 months
Physical Activity - 3 Month Change
Physical activity was assessed using the using the validated International Physical Activity Questionnaire short form. Participants were 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 were converted into metabolic equivalents per week. We converted raw scores into z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased physical activity; negative change scores reflect reduced physical activity.
Time frame: Baseline to 3 months
Emotional Well-being - 3 Month Change
We assessed emotional well-being using the 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. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased well-being; negative change scores reflect decreased emotional well-being.
Time frame: Baseline to 3 months
Self-regulation - 3 Month Change
We measured 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. We converted raw score to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved mind-body awareness; negative change scores reflect worse mind-body awareness.
Time frame: Baseline to 3 months
Diet - 3 Month Change
We measured 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. We converted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved diet; negative change scores reflect worse diet.
Time frame: Baseline and 3 months
Sleep Disturbance - 3 Month Change
We measured 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. Raw scores are converted to t-scores. Higher scores indicate more sleep disturbance. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased sleep disturbance; negative change scores reflect reduced sleep disturbance.
Time frame: Baseline to 3 months
Self-efficacy/Confidence 3 Month Change
We used a modified version of the 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. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved self-efficacy; negative change scores reflect worse self-efficacy.
Time frame: Baseline to 3 months
Global Quality of Life - Physical - 3 Month Change
We measured 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. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life.
Time frame: Baseline to 3 months
Global Quality of Life - Mental - 3 Month Change
We measured 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. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life.
Time frame: Baseline to 3 months
Loneliness / Social Isolation - 6 Month Change
Loneliness / social isolation was measured using the validated 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. Raw scores were converted to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased loneliness, negative change scores reflect decreased loneliness.
Time frame: Baseline to 6 months
Depression - 6 Month Change
We assessed 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. We concerted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased depressive symptoms; negative change scores reflect reduced depressive symptoms.
Time frame: baseline to 6 months
Cognitive Activity - 6 Month Change
We measured engagement in cognitive stimulating activities using the validated 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). Higher scores reflect more cognitive activity. We converted raw scores to standardized z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased cognitive activity; negative change scores reflect reduced cognitive activity.
Time frame: Baseline to 6 months
Physical Activity - 6 Month Change
Physical activity was assessed using the using the validated International Physical Activity Questionnaire short form. Participants were 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 were converted into metabolic equivalents per week. We converted raw scores into z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased physical activity; negative change scores reflect reduced physical activity.
Time frame: Baseline to 6 months
Emotional Well-being - 6 Month Change
We assessed emotional well-being using the 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. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased well-being; negative change scores reflect decreased emotional well-being.
Time frame: 0 to 6 months
Self-Regulation - 6 Month Change
We measured 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. We converted raw score to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved mind-body awareness; negative change scores reflect worse mind-body awareness.
Time frame: 0 to 6 months
Diet - 6 Month Change
We measured 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. We converted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved diet; negative change scores reflect worse diet.
Time frame: 0 to 6 months
Sleep Disturbance - 6 Month Change
We measured 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. Raw scores are converted to t-scores. Higher scores indicate more sleep disturbance. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased sleep disturbance; negative change scores reflect reduced sleep disturbance.
Time frame: 0 to 6 months
Self-efficacy/Confidence - 6 Month Change
We used a modified version of the 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. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved self-efficacy; negative change scores reflect worse self-efficacy.
Time frame: 0 to 6 months
Global Quality of Life - Physical - 6 Month Change
We measured 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. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life.
Time frame: 0 to 6 months
Global Quality of Life - Mental - 6 Month Change
We measured 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. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life.
Time frame: 0 to 6 months
792 initiated screening process, 342 were ineligible, 242 were not willing to participate or did not complete the screening process, and 208 consented
| Milestone | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Started | 55 | 55 | 55 |
| Completed | 44 | 37 | 41 |
| Not completed | 11 | 18 | 14 |
| Withdrew: Withdrawal by subject | 11 | 18 | 14 |
| Milestone | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Started | 44 | 37 | 41 |
| Completed | 43 | 30 | 40 |
| Not completed | 1 | 7 | 1 |
The Creyos online cognitive test battery included digit span, feature match, grammatical reasoning, paired associates, and token search. We converted raw scores to standardized z scores for each test using the group baseline mean and standard deviation. We then summed the standardized scores to create a composite cognitive score and re-standardized the composite score using the group baseline mean and standard deviation (baseline mean=0, SD=1). Positive change reflects improved cognitive performance.
| Change on z-score | Brain Health Academy | Brain Health Together + Brain Health Together Plus |
|---|---|---|
| Creyos Cognitive Composite - 3 Month | 0.27 (0.05 to 0.49) | 0.13 (-0.03 to 0.30) |
This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. We created a modified version that only included risk factors that are modifiable and targeted by our intervention (depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, and fish intake) using the weights from the original score. We then converted the calculated score to a z score using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased dementia risk; negative scores reflect reduced dementia risk.
| change on z-score | Brain Health Academy | Brain Health Together + Brain Health Together Plus |
|---|---|---|
| Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF) - 3 Month Change | 0.00 (-0.28 to 0.28) | -0.26 (-0.47 to -0.05) |
The Creyos online cognitive test battery included digit span, feature match, grammatical reasoning, paired associates, and token search. We converted raw scores to standardized z scores for each test using the group baseline mean and standard deviation. We then summed the standardized scores to create a composite cognitive score and re-standardized the composite score using the group baseline mean and standard deviation (baseline mean=0, SD=1). Positive change reflects improved cognitive performance.
| change on z-score | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Creyos Cognitive Composite - 6 Month Change | 0.30 (0.08 to 0.52) | 0.49 (0.22 to 0.76) | 0.10 (-0.14 to 0.34) |
This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. We created a modified version that only included risk factors that are modifiable and targeted by our intervention (depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, and fish intake) using the weights from the original score. We then converted the calculated score to a z-score using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased dementia risk; negative scores reflect reduced dementia risk.
| change on z-score | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF) - 6 Month Change | -0.19 (-2.33 to 0.06) | -0.31 (-0.61 to -0.01) | -0.43 (-0.69 to -0.16) |
Loneliness / social isolation was measured using the validated 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. Raw scores were converted to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased loneliness, negative change scores reflect decreased loneliness.
| change on z-score | Brain Health Academy | Brain Health Together + Brain Health Together Plus |
|---|---|---|
| Loneliness / Social Isolation - 3 Month Change | -0.11 (-0.31 to 0.09) | -0.29 (-0.44 to -0.13) |
We assessed 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. We concerted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased depressive symptoms; negative change scores reflect reduced depressive symptoms.
| change on z-score | Brain Health Academy | Brain Health Together + Brain Health Together Plus |
|---|---|---|
| Depression - 3 Month Change | -0.26 (-0.47 to -0.06) | -0.34 (-0.49 to -0.18) |
We measured engagement in cognitive stimulating activities using the validated 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). Higher scores reflect more cognitive activity. We converted raw scores to standardized z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased cognitive activity; negative change scores reflect reduced cognitive activity.
| change on z-score | Brain Health Academy | Brain Health Together + Brain Health Together Plus |
|---|---|---|
| Cognitive Activity - 3 Month Change | 0.22 (0.01 to 0.44) | 0.26 (0.09 to 0.42) |
Physical activity was assessed using the using the validated International Physical Activity Questionnaire short form. Participants were 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 were converted into metabolic equivalents per week. We converted raw scores into z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased physical activity; negative change scores reflect reduced physical activity.
| change on z-score | Brain Health Academy | Brain Health Together + Brain Health Together Plus |
|---|---|---|
| Physical Activity - 3 Month Change | 0.18 (-0.09 to 0.46) | 0.10 (-0.10 to 0.31) |
We assessed emotional well-being using the 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. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased well-being; negative change scores reflect decreased emotional well-being.
| change on z-score | Brain Health Academy | Brain Health Together + Brain Health Together Plus |
|---|---|---|
| Emotional Well-being - 3 Month Change | 0.13 (-0.10 to 0.36) | 0.21 (0.04 to 0.38) |
We measured 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. We converted raw score to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved mind-body awareness; negative change scores reflect worse mind-body awareness.
| change on z-score | Brain Health Academy | Brain Health Together + Brain Health Together Plus |
|---|---|---|
| Self-regulation - 3 Month Change | 0.14 (-0.11 to 0.39) | 0.28 (0.09 to 0.47) |
We measured 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. We converted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved diet; negative change scores reflect worse diet.
| change on z-score | Brain Health Academy | Brain Health Academy + Brain Health Together Plus |
|---|---|---|
| Diet - 3 Month Change | 0.37 (0.22 to 0.52) | 0.20 (0.01 to 0.40) |
We measured 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. Raw scores are converted to t-scores. Higher scores indicate more sleep disturbance. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased sleep disturbance; negative change scores reflect reduced sleep disturbance.
| change on z-score | Brain Health Academy | Brain Health Together + Brain Health Together Plus |
|---|---|---|
| Sleep Disturbance - 3 Month Change | -0.06 (-0.27 to 0.14) | -0.13 (-0.28 to 0.03) |
We used a modified version of the 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. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved self-efficacy; negative change scores reflect worse self-efficacy.
| change on z-score | Brain Health Academy | Brain Health Together + Brain Health Together Plus |
|---|---|---|
| Self-efficacy/Confidence 3 Month Change | 0.00 (-0.32 to 0.33) | -0.19 (-0.43 to 0.05) |
We measured 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. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life.
| change on z-score | Brain Health Academy | Brain Health Together + Brain Health Together Plus |
|---|---|---|
| Global Quality of Life - Physical - 3 Month Change | 0.18 (-0.02 to 0.39) | 0.15 (-0.01 to 0.31) |
We measured 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. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life.
| change on z-score | Brain Health Academy | Brain Health Together + Brain Health Together Plus |
|---|---|---|
| Global Quality of Life - Mental - 3 Month Change | 0.05 (-0.14 to 0.24) | 0.28 (0.14 to 0.42) |
Loneliness / social isolation was measured using the validated 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. Raw scores were converted to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased loneliness, negative change scores reflect decreased loneliness.
| change on z-score | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Loneliness / Social Isolation - 6 Month Change | -0.02 (-0.23 to 0.20) | -0.34 (-0.59 to -0.10) | -0.55 (-0.77 to -0.33) |
We assessed 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. We concerted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased depressive symptoms; negative change scores reflect reduced depressive symptoms.
| change on z-score | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Depression - 6 Month Change | -0.23 (-0.44 to -0.03) | -0.42 (-0.65 to -0.18) | -0.46 (-0.67 to -0.25) |
We measured engagement in cognitive stimulating activities using the validated 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). Higher scores reflect more cognitive activity. We converted raw scores to standardized z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased cognitive activity; negative change scores reflect reduced cognitive activity.
| change on z-score | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Cognitive Activity - 6 Month Change | 0.10 (-0.11 to 0.30) | 0.36 (0.12 to 0.60) | 0.36 (0.14 to 0.57) |
Physical activity was assessed using the using the validated International Physical Activity Questionnaire short form. Participants were 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 were converted into metabolic equivalents per week. We converted raw scores into z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased physical activity; negative change scores reflect reduced physical activity.
| change on z-score | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Physical Activity - 6 Month Change | 0.22 (-0.05 to 0.49) | -0.11 (-0.42 to 0.19) | 0.17 (-0.10 to 0.45) |
We assessed emotional well-being using the 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. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased well-being; negative change scores reflect decreased emotional well-being.
| change on z-score | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Emotional Well-being - 6 Month Change | 0.17 (-0.05 to 0.39) | 0.20 (-0.05 to 0.45) | 0.18 (-0.04 to 0.40) |
We measured 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. We converted raw score to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved mind-body awareness; negative change scores reflect worse mind-body awareness.
| change on z-score | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Self-Regulation - 6 Month Change | 0.09 (-0.16 to 0.34) | 0.19 (-0.10 to 0.47) | 0.34 (0.08 to 0.60) |
We measured 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. We converted raw scores to z-scores using the baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved diet; negative change scores reflect worse diet.
| change on z-score | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Diet - 6 Month Change | 0.34 (0.14 to 0.53) | 0.43 (0.20 to 0.66) | 0.43 (0.23 to 0.63) |
We measured 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. Raw scores are converted to t-scores. Higher scores indicate more sleep disturbance. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased sleep disturbance; negative change scores reflect reduced sleep disturbance.
| change on z-score | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Sleep Disturbance - 6 Month Change | -0.09 (-0.30 to 0.11) | -0.15 (-0.39 to 0.09) | -0.20 (-0.41 to 0.01) |
We used a modified version of the 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. We converted raw scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved self-efficacy; negative change scores reflect worse self-efficacy.
| change on z-score | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Self-efficacy/Confidence - 6 Month Change | -0.07 (-0.36 to 0.22) | -0.31 (-0.64 to 0.02) | -0.02 (-0.31 to 0.28) |
We measured 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. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life.
| change on z-score | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Global Quality of Life - Physical - 6 Month Change | 0.12 (-0.07 to 0.32) | 0.16 (-0.07 to 0.39) | 0.19 (-0.01 to 0.40) |
We measured 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. Raw scores are converted into T-scores for physical and mental quality of life. We converted t-scores to z-scores using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect improved quality of life; negative change scores reflect worsened quality of life.
| change on z-score | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| Global Quality of Life - Mental - 6 Month Change | 0.19 (-0.003 to 0.37) | 0.35 (0.13 to 0.57) | 0.42 (0.23 to 0.62) |
Collected over from enrollment until the end of follow-up, up to 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brain Health Academy | 0/55 (0%) | 3/55 (5.5%) | 20/55 (36.4%) |
| Brain Health Together | 0/55 (0%) | 3/55 (5.5%) | 15/55 (27.3%) |
| Brain Health Together Plus | 0/55 (0%) | 2/55 (3.6%) | 18/55 (32.7%) |
| Event | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| hospitalizationGeneral disorders | 3/55 | 3/55 | 2/55 |
| Event | Brain Health Academy | Brain Health Together | Brain Health Together Plus |
|---|---|---|---|
| FallMusculoskeletal and connective tissue disorders | 11/55 | 6/55 | 8/55 |
| Surgery/procedureSurgical and medical procedures | 5/55 | 2/55 | 6/55 |
| InfectionInfections and infestations | 2/55 | 1/55 | 5/55 |
| GeneralGeneral disorders | 4/55 | 5/55 | 2/55 |
| NeurologicalNervous system disorders | 1/55 | 4/55 | 0/55 |
| Age, Continuous(years) | Brain Health Academy | Brain Health Together | Brain Health Together Plus | Total |
|---|---|---|---|---|
| Mean | 71.1 ± 8.2 | 69.8 ± 7.3 | 69.7 ± 7.7 | 70.2 ± 7.7 |
| Sex/Gender, Customized(Participants) | Brain Health Academy | Brain Health Together | Brain Health Together Plus | Total |
|---|---|---|---|---|
| Woman | 40 | 42 | 40 | 122 |
| Man | 15 | 12 | 14 | 41 |
| Non-binary | 0 | 0 | 1 | 1 |
| Not reported | 0 | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Brain Health Academy | Brain Health Together | Brain Health Together Plus | Total |
|---|---|---|---|---|
| Asian | 5 | 4 | 4 | 13 |
| Black or African American | 1 | 3 | 5 | 9 |
| Hispanic or Latino/a/e (any race) | 2 | 3 | 1 | 6 |
| White (not Hispanic/Latino/a/e) | 43 | 40 | 41 | 124 |
| Multiple or Another Race/Ethnicity | 4 | 5 | 4 | 13 |
| Region of Enrollment(participants) | Brain Health Academy | Brain Health Together | Brain Health Together Plus | Total |
|---|---|---|---|---|
| United States | 55 | 55 | 55 | 165 |
| Lesbian, gay, or bisexual(Participants) | Brain Health Academy | Brain Health Together | Brain Health Together Plus | Total |
|---|---|---|---|---|
| Count of participants | 6 | 7 | 8 | 21 |
| Married/partnered(Participants) | Brain Health Academy | Brain Health Together | Brain Health Together Plus | Total |
|---|---|---|---|---|
| Count of participants | 26 | 25 | 32 | 83 |
| Live alone(Participants) | Brain Health Academy | Brain Health Together | Brain Health Together Plus | Total |
|---|---|---|---|---|
| Count of participants | 20 | 20 | 13 | 53 |
| College graduate(Participants) | Brain Health Academy | Brain Health Together | Brain Health Together Plus | Total |
|---|---|---|---|---|
| Count of participants | 46 | 38 | 39 | 123 |
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University of California, San Francisco