Clinical trial NCT05818423: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Cognitive Decline
Cognitive Deterioration
Cognitive Deficits, Mild
Cognitive Impairment, Mild
Keywords: Memory
Cognitive
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-04-18
Enrollment: 208
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maintain Your Brain Online Cognitive Test Battery-Change
timeFrame: Baseline and 3 months
measure: Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF)
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Physical activity-Change
timeFrame: Baseline and 3 months
measure: Depression-Change
timeFrame: Baseline and 3 months
measure: Loneliness / social isolation-Change
timeFrame: Baseline and 3 months
measure: Emotional well-being-Change
timeFrame: Baseline and 3 months
measure: Mind-body awareness-Change
timeFrame: Baseline and 3 months
measure: Diet-Change
timeFrame: Baseline and 3 months
measure: Obesity/weight-Change
timeFrame: Baseline and 3 months
measure: Sleep-Change
timeFrame: Baseline and 3 months
measure: Self-efficacy/Confidence-Change
timeFrame: Baseline and 3 months
measure: Cognitive activity-Change
timeFrame: Baseline and 3 months
measure: Alcohol-Change
timeFrame: Baseline and 3 months
measure: Smoking-Change
timeFrame: Baseline and 3 months
measure: Global quality of life-Change
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: Primary Investigator
name: Deborah Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
References: