Trial Outcomes & Findings for Evaluation of the Wits Workout Wellness Program for Older Adults (NCT NCT04928885)

NCT ID: NCT04928885

Last Updated: 2024-03-20

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 285 participants
• Primary outcome timeframe: Baseline prior to the workshop, at 3 months after baseline and at 6 months after baseline
• Results posted on: 2024-03-20

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	152	133
Overall Study 3 Months	130	123
Overall Study COMPLETED	123	122
Overall Study NOT COMPLETED	29	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Wits Workout Wellness Program for Older Adults

Baseline characteristics by cohort

Measure	WW Treatment Group n=152 Participants 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.	WW Control Group n=133 Participants 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.	Total n=285 Participants Total of all reporting groups
Age, Continuous	66.05921053 Years STANDARD_DEVIATION 10.24936345 • n=5 Participants	65.03759398 Years STANDARD_DEVIATION 8.82438599 • n=7 Participants	65.58246 Years STANDARD_DEVIATION 9.607676 • n=5 Participants
Sex: Female, Male Female	136 Participants n=5 Participants	121 Participants n=7 Participants	257 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	146 Participants n=5 Participants	126 Participants n=7 Participants	272 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	134 Participants n=5 Participants	119 Participants n=7 Participants	253 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	152 participants n=5 Participants	133 participants n=7 Participants	285 participants n=5 Participants

PRIMARY outcome

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

Population: Loss to follow-up

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).

Outcome measures

Measure	WW Treatment Group n=130 Participants 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.	WW Control Group n=123 Participants 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.
Change in Cognitive Function 6 Months	1.84 T score Standard Deviation 7.93	-.73 T score Standard Deviation 6.97
Change in Cognitive Function 3 Months	0.28 T score Standard Deviation 4.27	.65 T score Standard Deviation 4.08

PRIMARY outcome

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

Population: Loss to follow-up

Telephone Interview for Cognitive Status (TICS). Used to measure cognitive status. For TICS - the minimum = 0 maximum = 50. Higher scores mean better cognition.

Outcome measures

Measure	WW Treatment Group n=130 Participants 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.	WW Control Group n=123 Participants 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.
Change in Cognitive Status 3 Months	.96 score on a scale Standard Deviation 4.02	.92 score on a scale Standard Deviation 4.17
Change in Cognitive Status 6 Months	1.42 score on a scale Standard Deviation 4.15	1.22 score on a scale Standard Deviation 4.21

SECONDARY outcome

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

Population: Loss to follow-up

Social Provisions Scale. Range of total score should be 24-96 with higher scores being a better outcome.

Outcome measures

Measure	WW Treatment Group n=130 Participants 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.	WW Control Group n=123 Participants 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.
Change in Social Satisfaction 3 Months	.30 score on a scale Standard Deviation 5.72	-.72 score on a scale Standard Deviation 5.86
Change in Social Satisfaction 6 Months	0.23 score on a scale Standard Deviation 12.69	-.43 score on a scale Standard Deviation 12.79

SECONDARY outcome

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

Population: Number analyzed changes due to loss to follow-up.

Physical Activity Scale for the Elderly (PASE). Scores range from 0 to 793, with higher scores indicating greater physical activity

Outcome measures

Measure	WW Treatment Group n=152 Participants 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.	WW Control Group n=133 Participants 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.
Change in Physical Activity Levels 3 Months	57.34 score on a scale Standard Deviation 43.05	64.84 score on a scale Standard Deviation 60.41
Change in Physical Activity Levels 6 Months	68.35 score on a scale Standard Deviation 48.37	66.95 score on a scale Standard Deviation 35.0
Change in Physical Activity Levels Baseline	68.21 score on a scale Standard Deviation 50.3	71.29 score on a scale Standard Deviation 63.85

SECONDARY outcome

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

Population: Sample sizes change by time point due to loss to follow-up.

Perceived Stress Scale (PSS). Total scores range from 0 to 40. Higher scores indicate higher stress.

Outcome measures

Measure	WW Treatment Group n=152 Participants 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.	WW Control Group n=133 Participants 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.
Stress Baseline	21 score on a scale Standard Deviation 3.89	20.62 score on a scale Standard Deviation 3.5
Stress 3 Months	19.94 score on a scale Standard Deviation 3.31	20.26 score on a scale Standard Deviation 3.34
Stress 6 Months	19.65 score on a scale Standard Deviation 3.26	20.34 score on a scale Standard Deviation 3.89

SECONDARY outcome

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

Population: Loss to follow-up

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.

Outcome measures

Measure	WW Treatment Group n=130 Participants 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.	WW Control Group n=123 Participants 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.
Change in Sleep 3 Months	0.21 score on a scale Standard Deviation 1.82	-.17 score on a scale Standard Deviation 1.77
Change in Sleep 6 Months	7.23 score on a scale Standard Deviation 2.51	-6.37 score on a scale Standard Deviation 2.38

SECONDARY outcome

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

Population: Sample size varies by time point due to drop out/loss to follow up.

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.

Outcome measures

Measure	WW Treatment Group n=152 Participants 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.	WW Control Group n=133 Participants 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.
Self-efficacy 6 Months	50.49 T-score Standard Deviation 8.48	49.28 T-score Standard Deviation 7.97
Self-efficacy Baseline	46.89 T-score Standard Deviation 8.00	49.61 T-score Standard Deviation 8.93
Self-efficacy 3 Months	48.10 T-score Standard Deviation 8.47	50.22 T-score Standard Deviation 8.33

Adverse Events

WW Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

WW Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Julie Bobitt, PhD

The University of Illinois at Chicago

Phone: 312.355.0247

Email: jbobitt@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place