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

NCT05818423 | Completed Results DMC

• 2 other identifiers: 21-35002R44AG074727
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Memory; Cognitive

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (22)

• Loneliness / Social Isolation - 3 Month Change

  Baseline to 3 months

• Depression - 3 Month Change

  Baseline to 3 months

• Cognitive Activity - 3 Month Change

  Baseline and 3 months

• Physical Activity - 3 Month Change

  Baseline to 3 months

• Emotional Well-being - 3 Month Change

  Baseline to 3 months

Study Arms (3)

Brain Health Academy

EXPERIMENTAL

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

Brain Health Together

EXPERIMENTAL

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

Brain Health Together Plus

EXPERIMENTAL

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

Interventions

Brain Health Academy 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 Academy

Brain Health Together 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).

Brain Health Together

Maintain Brain Health Together 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).

Brain Health Together Plus

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Cognition Disorders; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Deborah Barnes
• Organization: University of California, San Francisco

deborah.barnes@ucsf.edu

415-298-5498

Study Officials

• Deborah Barnes, PhD

  Primary Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 18, 2023
• Study Start: April 10, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)