Evaluation of the Wits Workout Wellness Program for Older Adults

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04928885

Enrollment

285

Registered

2021-06-16

Start date

2021-07-07

Completion date

2022-08-30

Last updated

2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline, Health Behaviors, Self Efficacy, Social Isolation

Keywords

Cognitive Health, Older Adults, Socialization

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.

Interventions

BEHAVIORALWits Workout Program

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

OTHERControl 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Two-arm, randomized trial with a treatment group and a waitlist control group.

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Cognitive Function	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).
Change in Cognitive Status	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

Measure	Time frame	Description
Stress	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.
Change in Social Satisfaction	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.
Self-efficacy	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.
Change in Sleep	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.
Change in Physical Activity Levels	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

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. Wits Workout Program: 12 week, one hour per week multi-modal, interactive training.	152
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. 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.	133
Total	285

Baseline characteristics

Characteristic	WW Treatment Group	Total	WW Control Group
Age, Continuous	66.05921053 Years STANDARD_DEVIATION 10.24936345	65.58246 Years STANDARD_DEVIATION 9.607676	65.03759398 Years STANDARD_DEVIATION 8.82438599
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants	13 Participants	7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	146 Participants	272 Participants	126 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	3 Participants	2 Participants
Race (NIH/OMB) Black or African American	14 Participants	22 Participants	8 Participants
Race (NIH/OMB) More than one race	2 Participants	6 Participants	4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	134 Participants	253 Participants	119 Participants
Region of Enrollment United States	152 participants	285 participants	133 participants
Sex: Female, Male Female	136 Participants	257 Participants	121 Participants
Sex: Female, Male Male	16 Participants	28 Participants	12 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 152	0 / 133
other Total, other adverse events	0 / 152	0 / 133
serious Total, serious adverse events	0 / 152	0 / 133

Outcome results

Primary

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).