Clinical trial NCT04928885: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Social Isolation
Health Behaviors
Self Efficacy
Keywords: Cognitive Health
Older Adults
Socialization
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-06-16
Enrollment: 285
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, randomized trial with a treatment group and a waitlist control group.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Cognitive Function
timeFrame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
measure: Change in Cognitive Status
timeFrame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Secondary outcomes:
measure: Change in Social Satisfaction
timeFrame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
measure: Change in Physical Activity Levels
timeFrame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
measure: Stress
timeFrame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
measure: Change in Sleep
timeFrame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
measure: Self-efficacy
timeFrame: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Julie Bobitt, PhD
role: PRINCIPAL_INVESTIGATOR
References: