Brain Health Together: Development and Pilot Test

NCT ID: NCT06914947

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2022-10-11

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.

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Brain Health Together

Intervention Type: 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.

Interventions

Brain 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

R44AG074727

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R44AG074727-B

Identifier Type: -

Identifier Source: org_study_id