Evaluation of the Wits Workout Wellness Program for Older Adults

March 18, 2024 updated by: Julie L Bobitt, University of Illinois at Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

285

Phase

  • 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 Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago

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

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Wits Workout Program
12 week, one hour per week multi-modal, interactive training.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive Function
Time Frame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
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
Time Frame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
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
Time Frame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
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
Time Frame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
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
Time Frame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
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
Time Frame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
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
Time Frame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Julie Bobitt, PhD, University of Illinois at Chicago

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)

July 7, 2021

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0305
  • P30AG022849 (U.S. NIH Grant/Contract)

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.

Clinical Trials on Cognitive Decline

Clinical Trials on Wits Workout Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe