B-Fit Intervention to Improve Brain Health
B-Fit
1 other identifier
interventional
120
1 country
1
Brief Summary
An accumulating body of research indicates that activities such as exercise, active cognitive and social engagement, good sleep hygiene, stress reduction and proper nutrition are associated with the maintenance of cognitive health. Emerging data also suggests that healthy lifestyle behaviors may promote brain plasticity. Despite nationwide efforts to raise public awareness about brain health, there remains a gap concerning how to best promote behavioral change and help at-risk middle-aged and older adults adopt effective, evidence-based brain health behaviors into their everyday lives to maximize cognitive health. The objective of this study is to evaluate the efficacy of a 7-week group brain fitness intervention (B-Fit) for increasing preventative brain health behaviors and enhancing cognitive health in participants at-risk for cognitive impairment. We will also examine mechanisms of action of the B-Fit intervention through tracking of behavioral responses in the real-world environment using wearable sensors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2016
CompletedStudy Start
First participant enrolled
February 15, 2018
CompletedFirst Posted
Study publicly available on registry
March 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedOctober 9, 2018
October 1, 2018
4.9 years
February 15, 2016
October 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Healthy Aging Activity Engagement
(Subjective Measure) Healthy Aging Activity Engagement Scale (HAAE): participants use a 5-point Likert scale to rate level of agreement with engagement in healthy brain behaviors during the past week from strongly disagree (0) to strongly agree (5). Scores range from 32 to 160, with higher scores representing greater engagement in positive health behaviors.
Change in engagement in healthy brain aging behaviors as measured by the HAAE from baseline to post-test (appr. 2 months) and follow-up (appr. one-year).
Objective sensor-based behavior change detection with wearable sensors
(Objective Measure) Participants will wear an Actigraph for 1 week to capture objective data in the form of activity times, activity durations, mobility, activity level and sleep/time quality. We will apply the behavior change detection approach (BCD) to detect the magnitude of health-related changes in behavior patterns and to describe the nature of the changes (e.g., increased afternoon activity).
Change in activities captured by actigraphs and measured using a behavior change detection approach at baseline compared to post-test (appr. 2 months) and follow-up (appr. one-year).
Secondary Outcomes (4)
Physical Capability
Change in mobility as measured by the SPPB from baseline to post-test (appr. 2 months) and follow-up (appr. one-year).
Psychological Wellbeing
Change in psychological wellbeing as measured by the total score of the NIH Toolbox surveys from baseline to post-test (appr. 2 months) and follow-up (appr. one-year).
Cognitive Function
Change in fluid cognitive abilities as measured by the NIH Toolbox fluid cognition composite from baseline to post-test (appr. 2 months) and follow-up (appr. one-year).
Social Wellbeing
Change in social wellbeing as measured by the total score of the NIH surveys from baseline to post-test (appr. 2 months) and follow-up (appr. one-year).
Study Arms (3)
B-Fit intervention
EXPERIMENTALCombines group education about brain health with individualized goal-setting and group problem-solving to help participants effectively integrate healthy behavioral changes into their everyday lives.
Education Only
ACTIVE COMPARATORProvide group education about healthy behavior changes without problem-solving component.
Wait-list
NO INTERVENTIONNo intervention administered. Will be offered intervention following a delay.
Interventions
Individualized goal-setting and group problem-solving to help older adults effectively integrate realistic, healthy behavioral changes into their everyday lives
Education about healthy brain aging behaviors provided.
Eligibility Criteria
You may qualify if:
- Age 40+ (midlife and older adults)
You may not qualify if:
- Adults under the age of 40
- Adults who meet criteria for dementia
- Adults who cannot provide own informed consent
- Adults who cannot complete assessments or participate in the intervention protocols due to vision, hearing, communication or other difficulties
- Adults unable to read and comprehend information in English.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington State University
Pullman, Washington, 99164-4820, United States
Related Publications (1)
Boyd B, McAlister C, Arrotta K, Schmitter-Edgecombe M. Self-Reported Behavior Change and Predictors of Engagement With a Multidomain Brain Health Intervention for Midlife and Older Adults: A Pilot Clinical Trial. J Aging Health. 2022 Jan;34(1):109-119. doi: 10.1177/08982643211032483. Epub 2021 Jul 15.
PMID: 34266343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maureen Schmitter-Edgecombe, Ph.D.
Washington State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2016
First Posted
March 5, 2018
Study Start
February 15, 2018
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
October 9, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share