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

October 4, 2018 updated by: Washington State University

B-Fit Intervention to Improve Engagement in Healthy Brain Aging Activities in Middle-aged and Older Adults

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Pullman, Washington, United States, 99164-4820
        • Recruiting
        • Washington State University
        • Contact:
          • Malathi Jandhyala
          • Phone Number: 509-335-3668
          • Email: irb@wsu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in mobility as measured by the SPPB from baseline to post-test (appr. 2 months) and follow-up (appr. one-year).
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.
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
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.
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
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington State University

Investigators

  • Principal Investigator: Maureen Schmitter-Edgecombe, Ph.D., Washington State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

February 15, 2016

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WashingtonSU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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