Evaluation of the Wits Workout Wellness Program for Older Adults
Primary Purpose
Cognitive Decline, Social Isolation, Health Behaviors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wits Workout Program
Control Group that receives intervention after the study
Sponsored by

About this trial
This is an interventional prevention trial for Cognitive Decline focused on measuring Cognitive Health, Older Adults, Socialization
Eligibility Criteria
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.
Sites / Locations
- University of Illinois at Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
WW Treatment Group
WW Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Change in social satisfaction
Social Provisions Scale. Range of total score should be 24-96 with higher scores being a better outcome.
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
Change in stress
Perceived Stress Scale (PSS). Total scores range from 0 to 40. Higher scores indicate higher stress.
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.
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.
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.
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
Full Information
NCT ID
NCT04928885
First Posted
May 19, 2021
Last Updated
May 16, 2023
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT04928885
Brief Title
Evaluation of the Wits Workout Wellness Program for Older Adults
Official Title
Evaluation of the Wits Workout Wellness Program for Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Social Isolation, Health Behaviors, Self Efficacy
Keywords
Cognitive Health, Older Adults, Socialization
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm, randomized trial with a treatment group and a waitlist control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
285 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WW Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
WW Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wits Workout Program
Intervention Description
12 week, one hour per week multi-modal, interactive training.
Intervention Type
Other
Intervention Name(s)
Control Group that receives intervention after the study
Intervention Description
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 Outcome Measure Information:
Title
Change in cognitive function
Description
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).
Time Frame
Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Title
Change in cognitive status
Description
Telephone Interview for Cognitive Status (TICS). Used to measure cognitive status. For TICS - the minimum = 0 maximum = 50. Higher scores mean better cognition.
Time Frame
Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Secondary Outcome Measure Information:
Title
Change in social satisfaction
Description
Social Provisions Scale. Range of total score should be 24-96 with higher scores being a better outcome.
Time Frame
Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Title
Change in physical activity levels
Description
Physical Activity Scale for the Elderly (PASE). Scores range from 0 to 793, with higher scores indicating greater physical activity
Time Frame
Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Title
Change in stress
Description
Perceived Stress Scale (PSS). Total scores range from 0 to 40. Higher scores indicate higher stress.
Time Frame
Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Title
Change in sleep
Description
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.
Time Frame
Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Title
Change in self-efficacy
Description
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.
Time Frame
Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Title
Dietary changes
Description
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.
Time Frame
Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Title
Changes in general health quality of life
Description
Short Form Survey - 12 (SF-12). Scores range from 0 to 100, with higher scores indicating better quality of life
Time Frame
Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Bobitt, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Wits Workout Wellness Program for Older Adults
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