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Completed

NCT Number: NCT04928885

Evaluation of the Wits Workout Wellness Program for Older Adults

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.

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Key information

Conditions

Cognitive Decline Behavior Cognition Disorders Cognitive Dysfunction Health Behavior Health Behaviors Mental Disorders Neurocognitive Disorders Self Efficacy Social Behavior Social Isolation

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wits Workout Program

Behavioral

12 week, one hour per week multi-modal, interactive training.

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2021
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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