Evaluation of the Wits Workout Wellness Program for Older Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Wits Workout Wellness Program for Older Adults

Conditions
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Cognitive Decline, Social Isolation, Health Behaviors, Self Efficacy

Intervention / Treatment
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* Behavioral: Wits Workout Program
* Other: Control Group that receives intervention after the study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 years or older English-speaking and/or able to understand English Have no diagnosis of Alzheimer's or related dementia Score 28 or higher on the TICS cognitive screening Able to participate in the 12 week program Have not previously participated in a Wits Workout program Exclusion Criteria: Under age 50, Unable to speak or understand English, Have a diagnosis of Alzheimer's or related dementia, Score lower than 28 on TICS Plan to miss more than two weeks of the program (i.e. traveling during that time period) Have previously participated in a Wits Workout program.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm, randomized trial with a treatment group and a waitlist control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WW Treatment Group<br>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. | Behavioral: Wits Workout Program<br>* 12 week, one hour per week multi-modal, interactive training.<br>|
| Other: WW Control Group<br>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. | Other: Control Group that receives intervention after the study<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 
| Change in 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 O-2 I; higher scores indicate worse sleep quality. | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline | 
| Change in self-efficacy | PROMIS general self efficacy. The score range is 4-16. The scores are then changed into a T score. 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 | 
| Dietary changes | Modified semiquantitative food frequency questionnaire SFFQ - there is not a scoring range for this modified version- we are looking for improvements for each individual measure. For example, an uptake in fruits and vegetables consumed. | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline | 
| Changes in general health quality of life | Short Form Survey - 12 (SF-12). Scores range from 0 to 100, with higher scores indicating better quality of life | Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Health, Older Adults, Socialization