B-Fit Intervention to Improve Brain Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Health Behavior Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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B-Fit intervention

Combines 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.

Group Type EXPERIMENTAL

Problem-solving

Intervention Type BEHAVIORAL

Individualized goal-setting and group problem-solving to help older adults effectively integrate realistic, healthy behavioral changes into their everyday lives

Education

Intervention Type BEHAVIORAL

Education about healthy brain aging behaviors provided.

Education Only

Provide group education about healthy behavior changes without problem-solving component.

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

Education about healthy brain aging behaviors provided.

Wait-list

No intervention administered. Will be offered intervention following a delay.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Problem-solving

Individualized goal-setting and group problem-solving to help older adults effectively integrate realistic, healthy behavioral changes into their everyday lives

Intervention Type BEHAVIORAL

Education

Education about healthy brain aging behaviors provided.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes