NCT04928885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

July 7, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 20, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

May 19, 2021

Results QC Date

November 26, 2023

Last Update Submit

March 18, 2024

Conditions

Keywords

Cognitive HealthOlder AdultsSocialization

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Change in Social Satisfaction

    Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline

  • Change in Physical Activity Levels

    Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline

  • Stress

    Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline

  • Change in Sleep

    Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline

  • Self-efficacy

    Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline

Study Arms (2)

WW Treatment Group

EXPERIMENTAL

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

WW Control Group

OTHER

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

Interventions

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

WW Treatment Group

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.

WW Control Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionSocial IsolationHealth Behavior

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersSocial BehaviorBehavior

Results Point of Contact

Title
Dr. Julie Bobitt, PhD
Organization
The University of Illinois at Chicago

Study Officials

  • Julie Bobitt, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two-arm, randomized trial with a treatment group and a waitlist control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 19, 2021

First Posted

June 16, 2021

Study Start

July 7, 2021

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

March 20, 2024

Results First Posted

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations