Brain Health Together: Development and Pilot Test

NCT06914947 | Completed

• 2 other identifiers: R44AG074727-BR44AG074727
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study were to develop and pilot-test Brain Health Together (BHT), a 12-week, virtual-group program that combines our evidence-based, mind-body, group movement program with brain health education and coaching to reduce dementia risk through targeting modifiable risk factors among older adults with cognitive impairment.

Conditions

Cognitive Impairment; Subjective Cognitive Decline; Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (2)

• Intervention Feasibility

  To examine feasibility, the investigators tracked participant attendance, calculated as the mean±standard deviation (SD) of sessions completed by each participant.

  12 weeks

• Acceptability

  The investigators asked participants how likely they are to recommend BHT to others on a scale from 0 (not at all likely) to 10 (extremely likely) and calculated a net promoter score as the percentage of promoters (scores of 9 or 10) minus the percentage of detractors (scores of 0 to 6).

  12 weeks

Study Arms (1)

Single-arm Pilot

12-week pilot study with data collection and analysis at the completion of the initial 4 weeks of the program and at the completion of 12 weeks.

Behavioral: Brain Health Together

Interventions

Brain Health Together BEHAVIORAL

Each week, the program included a 1-hour group brain health education class, a 1-hour group Moving Together class, and a 30-minute individual brain health coaching session (total: 2.5 hours/week). Before the first session, participants were asked to complete a brief online survey about lifestyle behaviors and medical conditions related to dementia risk. The first 4 brain health education classes focused on general content to introduce and reinforce the concept that healthy lifestyle behaviors and management of chronic medical conditions can improve cognitive function, delay cognitive decline, and potentially prevent dementia. Another goal was to introduce participants to health coaching and to help participants each set specific, measurable, achievable, realistic, time-limited (SMART) goals to improve brain health. The remaining 8 weeks were adjusted to accommodate participant feedback in the early portion of the pilot study.

Single-arm Pilot

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our study population included people who were active participants in the Moving Together program as well as a purposeful sample of individuals who were not familiar with the Moving Together program. Together these individuals' perceptions would facilitate further examination and identification of challenges in understanding and managing MCI. Pilot Inclusion Criteria: * Mild cognitive impairment or subjective cognitive decline * English language proficiency * Active participants in Moving Together (Intervention Arm) Pilot Exclusion Criteria: * wheelchair user; medical condition, physical limitation, visual or hearing impairment or psychiatric condition that could affect ability to participate in a virtually delivered multicomponent intervention * moderate/severe dementia severity

You may qualify if:

• Mild cognitive impairment or subjective cognitive decline
• English language proficiency
• Active participants in Moving Together (Intervention Arm)

You may not qualify if:

• wheelchair user
• medical condition, physical limitation, visual or hearing impairment or psychiatric condition that could affect ability to participate in a virtually-delivered multicomponent intervention
• moderate/severe dementia severity

Sponsors & Collaborators

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

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 7, 2025
• Study Start: September 30, 2021
• Primary Completion: September 6, 2022
• Study Completion: October 11, 2022
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)