An interventional study of Problem-solving and Education in Health Behavior and Aging, sponsored by Washington State University. Status unknown at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Washington State University · Not applicable, Interventional, and Prevention
Among 421 studies in Health Behavior with a site in United States — 66 open to participants now, 86 under way, 1 of them phase 3. Health Behavior · United States.
Among the 421 studies in Health Behavior with a site in United States, this one is the 197th largest by planned enrollment of the 385 interventional ones that give a count, is one of 25 that started in 2018, is one of 363 with no phase, and was the 115th registered.
968 studies on the registry are indexed under Health Behavior; 166 are open to participants now.
Browse Health Behavior studies →66 of the 421 studies in Health Behavior with a site in United States are open now. Recruiting first, the newest first:
University of Alabama at Birmingham · Sites in United States
Ages 25–65
University of South Florida · Sites in United States
Ages 18–70
St. Jude Children's Research Hospital · Sites in United States
Ages 26+
William Brandenburg, MD · Sites in United States
Ages 18+ · Healthy volunteers
University of North Carolina, Chapel Hill · Sites in United States
Ages 21+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 93 Health Behavior studies recruiting now, 39 (42%) set no upper age limit and 37 (40%) stop at 75 or younger; 25 take children under 18; 58 take healthy volunteers.
This study: 40 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
421 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 10 · Phase 3 6 · Phase 4 1
First in 1999; this study’s year is marked. 25 started in 2018.
This study's planned enrollment of 120 is below the median of 150 across 825 interventional studies indexed under Health Behavior.
Median enrollment 130 across the 385 interventional studies, 108 across the 36 observational. Of the 319 that completed or were terminated, 88 (28%) have results posted.
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18 of 421 have an industry lead sponsor. The 10 most frequent:
Washington State University is the lead sponsor of 83 studies on the registry; 16 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
Washington State University has 2 studies filed under Health Behavior — fewer than ten, so there is no comparison to draw.
26 of the studies in Health Behavior with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05397951University of North Carolina, Chapel HillThe Validation Study of Bioelectronics | 2026-11 |
| NCT05760573Rutgers, The State University of New JerseyThe Ready and Healthy for Kindergarten Study | 2026-11-30 |
| NCT07055165University of OklahomaConnect2Care: Prostate Cancer Education and Screenings for African American Men | 2026-12 |
| NCT06684483National Institutes of Health Clinical Center (CC)The Impact of Heavy Alcohol Use on Saliva and Oral Health | 2026-12-01 |
| NCT05619705Johns Hopkins UniversityHealthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women | 2026-12-15 |
Add all 26 to your calendar (.ics) → With an account.
Among the 421 studies in Health Behavior with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Behavioral: Education
Provide group education about healthy behavior changes without problem-solving component.
Behavioral: Education
No intervention administered. Will be offered intervention following a delay.
Individualized goal-setting and group problem-solving to help older adults effectively integrate realistic, healthy behavioral changes into their everyday lives
Education about healthy brain aging behaviors provided.
Healthy Aging Activity Engagement
(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.
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).
Objective sensor-based behavior change detection with wearable sensors
(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).
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).
Physical Capability
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.
Time frame: Change in mobility as measured by the SPPB from baseline to post-test (appr. 2 months) and follow-up (appr. one-year).
Psychological Wellbeing
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.
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).
Cognitive Function
NIH Toolbox Fluid Cognition Composite Score will be used to assess for change in cognition.
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).
Social Wellbeing
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.
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).
Plan to share: No
Started Feb 2018 (actual). Primary completion is estimated for Dec 2022, 58 months after the start.
Of 568 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's planned 58 months is above that.
Counting every sponsor, half of 586 studies reached it within 15 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Washington State University