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

NCT ID: NCT05818423

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2024-11-30

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment Cognitive Decline Cognitive Deterioration Cognitive Deficits, Mild Cognitive Impairment, Mild

Keywords

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Memory Cognitive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Brain Health Academy

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)

Group Type EXPERIMENTAL

Brain Health Academy

Intervention Type BEHAVIORAL

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).

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)

Group Type EXPERIMENTAL

Brain Health Together

Intervention Type BEHAVIORAL

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).

Maintain 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)

Group Type EXPERIMENTAL

Maintain Brain Health Together

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type 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).

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deborah Barnes, PhD

Role: PRINCIPAL_INVESTIGATOR

Primary Investigator

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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R44AG074727

Identifier Type: NIH

Identifier Source: secondary_id

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R44AG074727

Identifier Type: NIH

Identifier Source: org_study_id

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