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B-Fit Intervention to Improve Brain Health (B-Fit)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03454074
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : October 9, 2018
Information provided by (Responsible Party):
Washington State University

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.

Condition or disease Intervention/treatment Phase
Health Behavior Aging Behavioral: Problem-solving Behavioral: Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: B-Fit Intervention to Improve Engagement in Healthy Brain Aging Activities in Middle-aged and Older Adults
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Arm Intervention/treatment
Experimental: 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.
Behavioral: Problem-solving
Individualized goal-setting and group problem-solving to help older adults effectively integrate realistic, healthy behavioral changes into their everyday lives

Behavioral: Education
Education about healthy brain aging behaviors provided.

Active Comparator: Education Only
Provide group education about healthy behavior changes without problem-solving component.
Behavioral: Education
Education about healthy brain aging behaviors provided.

No Intervention: Wait-list
No intervention administered. Will be offered intervention following a delay.

Primary Outcome Measures :
  1. Healthy Aging Activity Engagement [ Time Frame: 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). ]
    (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.

  2. Objective sensor-based behavior change detection with wearable sensors [ Time Frame: 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). ]
    (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).

Secondary Outcome Measures :
  1. Physical Capability [ Time Frame: Change in mobility as measured by the SPPB from baseline to post-test (appr. 2 months) and follow-up (appr. one-year). ]
    The Short Physical Performance Battery (SPPB) will provide a composite measure of physical capability. The SPPB combines the results of gait speed, chair stand and balance tests.

  2. Psychological Wellbeing [ Time Frame: 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). ]
    The concept of psychological well-being will be captured by the NIH Toolbox surveys that measure the following three components: positive affect, general life satisfaction, and meaning and purpose. A total score will be computed.

  3. Cognitive Function [ Time Frame: 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). ]
    NIH Toolbox Fluid Cognition Composite Score will be used to assess for change in cognition.

  4. Social Wellbeing [ Time Frame: 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). ]
    The concept of social wellbeing will be captured by by the NIH Toolbox surveys that measure the following components: emotional support, friendship, instrumental support, loneliness, perceived hostility, and perceived rejection. A total score will be computed.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03454074

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Contact: Maureen Schmitter-Edgecombe, Ph.D. 5093350170
Contact: Stephanie Saltness, B.S. 5093354033

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United States, Washington
Washington State University Recruiting
Pullman, Washington, United States, 99164-4820
Contact: Malathi Jandhyala    509-335-3668   
Sponsors and Collaborators
Washington State University
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Principal Investigator: Maureen Schmitter-Edgecombe, Ph.D. Washington State University
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Responsible Party: Washington State University Identifier: NCT03454074    
Other Study ID Numbers: WashingtonSU
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington State University:
healthy aging
behavior change
older adults