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CompletedNCT06914947Updated Apr 10, 2025

Brain Health Together: Development and Pilot Test

An observational study in Cognitive Impairment, Subjective Cognitive Decline and Mild Cognitive Impairment (MCI), sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
16
Ages
65 Years and older
Sex
All
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Study 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.

Read the detailed description

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.

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Conditions studied

  • Cognitive Impairment
  • Subjective Cognitive Decline
  • Mild Cognitive Impairment (MCI)
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In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's enrollment of 16 is below the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
16 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • BehavioralBrain Health Together

    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.

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What researchers measure

Primary outcomes

  1. Intervention Feasibility

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

    Time frame: 12 weeks

  2. 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).

    Time frame: 12 weeks

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Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94158, United States
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References and documents

Individual participant data

Plan to share: No — Given the small number of participants and the exploratory nature of this trial, participants could potentially be identifiable.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06914947
Lead sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Apr 7, 2025
Start date
Sep 30, 2021
Primary completion
Sep 6, 2022
Completion
Oct 11, 2022
Last update
Apr 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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