Back to resultsBrain Health Together: A Live-Streaming Group-Based Digital Program
Primary Purpose
Mild Cognitive Impairment, Cognitive Decline, Cognitive Deterioration
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain Health Academy
Brain Health Together
Maintain Brain Health Together
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Memory, Cognitive
Eligibility Criteria
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.
Sites / Locations
- University of California, San FranciscoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Brain Health Academy
Brain Health Together
Maintain Brain Health Together
Arm Description
Participant 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)
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)
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)
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
Alcohol-Change
The investigators will measure alcohol consumption using 2 items in the ANU-ADRI that ask about frequency and amount of alcohol consumption.
Smoking-Change
The investigators will assess smoking with standard questions about tobacco use ever and during the past 7 days
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.
Full Information
NCT ID
NCT05818423
First Posted
March 24, 2023
Last Updated
April 25, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05818423
Brief Title
Brain Health Together: A Live-Streaming Group-Based Digital Program
Official Title
Brain Health Together: A Live-Streaming Group-Based Digital Program
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to develop and test a comprehensive Brain Health Together program for older adults living with cognitive decline.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Cognitive Decline, Cognitive Deterioration, Cognitive Deficits, Mild, Cognitive Impairment, Mild
Keywords
Memory, Cognitive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brain Health Academy
Arm Type
Experimental
Arm Description
Participant 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)
Arm Title
Brain Health Together
Arm Type
Experimental
Arm Description
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)
Arm Title
Maintain Brain Health Together
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Brain Health Academy
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Brain Health Together
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Maintain Brain Health Together
Intervention Description
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).
Primary Outcome Measure Information:
Title
Maintain Your Brain Online Cognitive Test Battery-Change
Description
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.
Time Frame
Baseline and 3 months
Title
Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF)
Description
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.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Physical activity-Change
Description
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.
Time Frame
Baseline and 3 months
Title
Depression-Change
Description
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.
Time Frame
Baseline and 3 months
Title
Loneliness / social isolation-Change
Description
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.
Time Frame
Baseline and 3 months
Title
Emotional well-being-Change
Description
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.
Time Frame
Baseline and 3 months
Title
Mind-body awareness-Change
Description
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.
Time Frame
Baseline and 3 months
Title
Diet-Change
Description
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.
Time Frame
Baseline and 3 months
Title
Obesity/weight-Change
Description
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.
Time Frame
Baseline and 3 months
Title
Sleep-Change
Description
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.
Time Frame
Baseline and 3 months
Title
Self-efficacy/Confidence-Change
Description
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.
Time Frame
Baseline and 3 months
Title
Cognitive activity-Change
Description
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).
Time Frame
Baseline and 3 months
Title
Alcohol-Change
Description
The investigators will measure alcohol consumption using 2 items in the ANU-ADRI that ask about frequency and amount of alcohol consumption.
Time Frame
Baseline and 3 months
Title
Smoking-Change
Description
The investigators will assess smoking with standard questions about tobacco use ever and during the past 7 days
Time Frame
Baseline and 3 months
Title
Global quality of life-Change
Description
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.
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deanna Mercer
Phone
415-326-3888
Email
deanna.mercer@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Barnes, PhD
Phone
415-298-5498
Email
deborah.barnes@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Barnes, PhD
Organizational Affiliation
Primary Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deanna Mercer
Phone
415-326-3888
Email
deanna.mercer@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Deborah Barnes, PhD, MPH
Email
deborah.barnes@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Deborah E Barnes, PhD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Brain Health Together: A Live-Streaming Group-Based Digital Program
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