Clinical trial NCT03454074: B-Fit Intervention to Improve Brain Health
Official title: B-Fit Intervention to Improve Engagement in Healthy Brain Aging Activities in Middle-aged and Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Aging
Keywords: healthy aging
behavior change
older adults
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Participants will be middle-aged and older adults. Participants will be randomized to one of three conditions (B-fit, education only, wait-list). Outcome measures will be administered at baseline, post-treatment and at a one-year follow-up. Participants will also be asked to wear an actigraph for 7 days at baseline, post intervention and follow-up. One or two clinicians will lead the intervention groups, which will each have 8-12 group members. Both the B-Fit and education control conditions will meet 2 hours per week for 7 weeks. Participants in both conditions will receive identical educational materials provided in the form of weekly learning packets and presented to the group by the study clinician(s). At the first meeting, group members will be presented with an overview of the brain, cognitive aging, mild cognitive impairment, and dementia. Each subsequent group meeting will cover a specific topic. The topics will be presented to all groups in the following order: cognitive engagement, exercise and cardiovascular risk factors, nutrition, social engagement, sleep and stress reduction, and compensatory strategy use. The control condition will include presentation of the educational materials followed by expanded discussion about the materials among group members. In contrast, each meeting of the B-Fit intervention will follow a highly structured format. The format is designed to aid participants in identifying and setting realistic and valuable individualized brain health goals and in obtaining group support through problem-solving, modeling and encouragement.

Eligibility criteria: Inclusion Criteria:

* Age 40+ (midlife and older adults)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Healthy Aging Activity Engagement
timeFrame: 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).
measure: Objective sensor-based behavior change detection with wearable sensors
timeFrame: 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:
measure: Physical Capability
timeFrame: Change in mobility as measured by the SPPB from baseline to post-test (appr. 2 months) and follow-up (appr. one-year).
measure: Psychological Wellbeing
timeFrame: 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).
measure: Cognitive Function
timeFrame: 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).
measure: Social Wellbeing
timeFrame: 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).
Other outcomes:
Locations:
city: Pullman
country: United States
facility: Washington State University
state: Washington
Study officials:
affiliation: Washington State University
name: Maureen Schmitter-Edgecombe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.