Brain Health Together: A Live-Streaming Group-Based Digital Program

The purpose of this study is to develop and test a comprehensive Brain Health Together program for older adults living with cognitive decline.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Cognitive Decline; Cognitive Deterioration; Cognitive Impairment, Mild; Cognitive Deficits, Mild
• Intervention / Treatment: Behavioral: Brain Health Academy; Behavioral: Brain Health Together; Behavioral: Maintain Brain Health Together

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English language fluency;*
• live in U.S.;
• cognitive decline (subjective cognitive decline OR diagnosis of mild cognitive impairment in the past 12 months)
• ready to make lifestyle changes to improve brain health;
• have 2 or more brain health risk factors (e.g., low physical activity, depression, hypertension, diabetes, etc)
• have a desktop or laptop computer or iPad/tablet with a video camera;
• have broadband internet access;
• able to participate in online, live-streaming classes with two-way video

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)

• Schizophrenia or other psychotic disorder
• Autism or autism spectrum disorder
• Major mood or anxiety disorder that is not well-controlled (e.g., symptoms of depression or anxiety that made it hard to do daily tasks in past 6 months)
• Fracture of spine ("compression fracture") in the past 12 months
• Vertigo or severe dizziness in the past 12 months
• Severe vision or hearing impairment (e.g., unable to see and hear well enough to watch a movie on TV);
• Stroke or heart attack in the past 12 months
• Physical limitation that would restrict ability to participate (e.g., use wheelchair or walker to get around home, unable to stand up from sitting without assistance)
• Currently in another research study that could confound results of this study (e.g., drug study or other study to improve brain health)
• Previous participation in Moving Together or Brain Health Together
• Limited life expectancy (e.g., enrolled in hospice, undergoing cancer treatment)

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brain Health Together; 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; 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).
Experimental: Brain Health Academy; 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; 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).
Experimental: Brain Health Together Plus; 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 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	0 to 6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Deborah Barnes, PhD, Primary Investigator

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Memory; Cognitive
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Neurocognitive Disorders; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Cognitive Dysfunction; Lymphoma, Follicular; Cognition Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Benzocaine
• Other Study ID Numbers: 21-35002; R44AG074727 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing permissions will be configured to ensure files containing PHI can only be accessed by authorized individuals. Two-step verification will be used as an additional safeguard against unauthorized access. Permissions will be updated when personnel roles change and they no longer need access to PHI or when they leave the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No