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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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