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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG022849 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Aging (NIA) | NIH |
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About 11% of the U.S. older adult population is at risk for or suffers from subjective cognitive decline. While some factors such as genetics and habitual physiological changes that affect brain health cannot be changed, research has shown that lifestyle changes such as participation in regular physical activity, staying socially engaged, and managing stress and diet can help to delay or reduce cognitive decline. Yet few brain health promotion programs exist and those that do fail to focus on global health and wellness as a strategy to improve brain health. Wits Workout is a holistic, 12-session, 60-minute per session, multi-modal workshop series that offers adults ages 50 and older facilitated, interactive dialogue and activities about behaviors that promote brain health. Each week includes a different themed module which has four activities and a training component.
While research has shown that lifestyle changes such as participation in regular physical activity, staying socially engaged, and managing stress can help to delay or reduce cognitive decline, few cognitive brain health programs exist. Those that do are targeted to a specific audience (i.e., Alzheimer's and related dementias) and primarily focus on one health domain (i.e. physical activity, diet) without the additional focus on multi-dimensions of health, which can also include intellectual engagement, social isolation, stress, sleep, and self-efficacy. Thus, there is a need for a more holistic cognitive health program aimed toward the general older adult population and particularly those that are underserved due to geographic location.
Wits Workout, is a multi-modal 12-session (60 min/week) workshop series designed to enhance brain health among people ages 50 and older. Wits Workout addresses multiple factors that affect cognitive health such as physical activity, diet, intellectual engagement, social isolation, stress, sleep, and self-efficacy. The holistic workshop series is designed to be lay-leader led, interactive, and experiential. Preliminary evaluations demonstrate that this educational series serves a need in reducing isolation, increasing physical activity, promoting intellectual engagement, and enhancing overall brain health in older participants, all of which complement current aging brain health research. The researchers propose to conduct a two-arm randomized controlled trial with a treatment (workshop) group (n=120) and wait-list control group (n=120) who will receive the program after the 6-month study period is completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WW Treatment Group | Experimental | Individuals will receive the 12-week Wits Workout Program. Individuals will take the baseline, 3 mos and 6 mos follow-up surveys. They will also take the Wits Workout satisfaction survey and participate in the 6 mos focus-groups. |
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| WW Control Group | Other | Individuals will be on a waitlist and will take the baseline, 3 mos and 6 mos. assessments. They will receive the Wits Workout workshop after the 6 month study period is completed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wits Workout Program | Behavioral | 12 week, one hour per week multi-modal, interactive training. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Function | The PROMIS Cognitive Function measure used to measure cognitive functioning. Raw score is converted into the T-score, with 50 being the mean score. 10 T-score is one standard deviation. Therefore, score above 50 means that a person is better than the average population in mental ability, and lower score meaning worse or disability. The score changing over time can indicate decline in cognitive function (lower score) or improved cognitive function (higher score) or no decline or improvement (same score). | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
| Change in Cognitive Status | Telephone Interview for Cognitive Status (TICS). Used to measure cognitive status. For TICS - the minimum = 0 maximum = 50. Higher scores mean better cognition. | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Social Satisfaction | Social Provisions Scale. Range of total score should be 24-96 with higher scores being a better outcome. | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
| Change in Physical Activity Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie Bobitt, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | WW Treatment Group | Individuals will receive the 12-week Wits Workout Program. Individuals will take the baseline, 3 mos and 6 mos follow-up surveys. They will also take the Wits Workout satisfaction survey and participate in the 6 mos focus-groups. Wits Workout Program: 12 week, one hour per week multi-modal, interactive training. |
| FG001 | WW Control Group | Individuals will be on a waitlist and will take the baseline, 3 mos and 6 mos. assessments. They will receive the Wits Workout workshop after the 6 month study period is completed. Control Group that receives intervention after the study: The control group will not receive the intervention during study period but will take baseline, 3 mos and 6 mos surveys. They will complete the workshop after the study period is over. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Loss to follow-up
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| ID | Title | Description |
|---|---|---|
| BG000 | WW Treatment Group | Individuals will receive the 12-week Wits Workout Program. Individuals will take the baseline, 3 mos and 6 mos follow-up surveys. They will also take the Wits Workout satisfaction survey and participate in the 6 mos focus-groups. Wits Workout Program: 12 week, one hour per week multi-modal, interactive training. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Cognitive Function | The PROMIS Cognitive Function measure used to measure cognitive functioning. Raw score is converted into the T-score, with 50 being the mean score. 10 T-score is one standard deviation. Therefore, score above 50 means that a person is better than the average population in mental ability, and lower score meaning worse or disability. The score changing over time can indicate decline in cognitive function (lower score) or improved cognitive function (higher score) or no decline or improvement (same score). | Loss to follow-up | Posted | Mean | Standard Deviation | T score | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
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Enrollment through 6 month follow-up time point.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | WW Treatment Group | Individuals will receive the 12-week Wits Workout Program. Individuals will take the baseline, 3 mos and 6 mos follow-up surveys. They will also take the Wits Workout satisfaction survey and participate in the 6 mos focus-groups. Wits Workout Program: 12 week, one hour per week multi-modal, interactive training. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie Bobitt, PhD | The University of Illinois at Chicago | 312.355.0247 | jbobitt@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2021 | Mar 11, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2021 | Mar 18, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D012934 | Social Isolation |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
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Two-arm, randomized trial with a treatment group and a waitlist control group.
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| Control Group that receives intervention after the study | Other | The control group will not receive the intervention during study period but will take baseline, 3 mos and 6 mos surveys. They will complete the workshop after the study period is over. |
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Physical Activity Scale for the Elderly (PASE). Scores range from 0 to 793, with higher scores indicating greater physical activity |
| Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
| Stress | Perceived Stress Scale (PSS). Total scores range from 0 to 40. Higher scores indicate higher stress. | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
| Change in Sleep | Pittsburgh Sleep Quality Index (PSQI). The PSQI has 7 sections which are scored. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores indicate worse sleep quality. | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
| Self-efficacy | PROMIS general self efficacy short-form. Survey scores are changed into a T score, with a mean of 50 and a standard deviation of 10. The higher the score the greater the self-efficacy. | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
| BG001 |
| WW Control Group |
Individuals will be on a waitlist and will take the baseline, 3 mos and 6 mos. assessments. They will receive the Wits Workout workshop after the 6 month study period is completed. Control Group that receives intervention after the study: The control group will not receive the intervention during study period but will take baseline, 3 mos and 6 mos surveys. They will complete the workshop after the study period is over. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | WW Control Group | Individuals will be on a waitlist and will take the baseline, 3 mos and 6 mos. assessments. They will receive the Wits Workout workshop after the 6 month study period is completed. Control Group that receives intervention after the study: The control group will not receive the intervention during study period but will take baseline, 3 mos and 6 mos surveys. They will complete the workshop after the study period is over. |
|
|
| Primary | Change in Cognitive Status | Telephone Interview for Cognitive Status (TICS). Used to measure cognitive status. For TICS - the minimum = 0 maximum = 50. Higher scores mean better cognition. | Loss to follow-up | Posted | Mean | Standard Deviation | score on a scale | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
|
|
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| Secondary | Change in Social Satisfaction | Social Provisions Scale. Range of total score should be 24-96 with higher scores being a better outcome. | Loss to follow-up | Posted | Mean | Standard Deviation | score on a scale | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
|
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| Secondary | Change in Physical Activity Levels | Physical Activity Scale for the Elderly (PASE). Scores range from 0 to 793, with higher scores indicating greater physical activity | Number analyzed changes due to loss to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
|
|
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| Secondary | Stress | Perceived Stress Scale (PSS). Total scores range from 0 to 40. Higher scores indicate higher stress. | Sample sizes change by time point due to loss to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
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| Secondary | Change in Sleep | Pittsburgh Sleep Quality Index (PSQI). The PSQI has 7 sections which are scored. The seven component scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores indicate worse sleep quality. | Loss to follow-up | Posted | Mean | Standard Deviation | score on a scale | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
|
|
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| Secondary | Self-efficacy | PROMIS general self efficacy short-form. Survey scores are changed into a T score, with a mean of 50 and a standard deviation of 10. The higher the score the greater the self-efficacy. | Sample size varies by time point due to drop out/loss to follow up. | Posted | Mean | Standard Deviation | T-score | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline |
|
|
|
| 1 |
| 152 |
| 0 |
| 152 |
| 0 |
| 152 |
| EG001 | WW Control Group | Individuals will be on a waitlist and will take the baseline, 3 mos and 6 mos. assessments. They will receive the Wits Workout workshop after the 6 month study period is completed. Control Group that receives intervention after the study: The control group will not receive the intervention during study period but will take baseline, 3 mos and 6 mos surveys. They will complete the workshop after the study period is over. | 0 | 133 | 0 | 133 | 0 | 133 |
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| D001519 |
| Behavior |
| 6 Months |
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| 6 Months |
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| 3 Months |
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| 6 Months |
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| 3 Months |
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| 6 Months |
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| 6 Months |
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| 3 Months |
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| 6 Months |
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