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Completed

NCT Number: NCT06914947

Brain Health Together: Development and Pilot Test

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.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment (MCI) Neurocognitive Disorders Subjective Cognitive Decline

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

About this study

Our study design for developing, pilot-testing, and refining the BHT program was conducted in 2 phases. In Phase 1, the investigators used a human-centered design approach to deeply understand and respond to the needs, challenges, and motivations of potential users when developing the BHT program. In Phase 2, the investigators performed a pilot study to refine BHT program content and assess acceptability and potential feasibility.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

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.

Primary outcomes

  1. Intervention Feasibility

    Time frame: 12 weeks

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

  2. Acceptability

    Time frame: 12 weeks

    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).

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Brain Health Together: Use of Human-centered Design to Develop and Pilot a Virtual Group Brain Health Program

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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