Trial Outcomes & Findings for Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Hybrid Effectiveness-Implementation Study (NCT NCT03929393)

NCT ID: NCT03929393

Last Updated: 2023-07-21

Results Overview

Minutes/week spent in ≥10-min bouts of MVPA

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

176 participants

Primary outcome timeframe

Baseline

Results posted on

2023-07-21

Participant Flow

Participant milestones

Participant milestones
Measure
Mindful Movement
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Overall Study
STARTED
86
90
Overall Study
COMPLETED
82
80
Overall Study
NOT COMPLETED
4
10

Reasons for withdrawal

Reasons for withdrawal
Measure
Mindful Movement
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Overall Study
Death
1
0
Overall Study
Time Commitment
2
5
Overall Study
Motor Vehicle Accident
0
1
Overall Study
Difficulty Using Videoconferencing Technology
0
1
Overall Study
Other
1
3

Baseline Characteristics

Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Hybrid Effectiveness-Implementation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Total
n=176 Participants
Total of all reporting groups
Age, Continuous
65.6 years
STANDARD_DEVIATION 7.2 • n=5 Participants
66.8 years
STANDARD_DEVIATION 8.4 • n=7 Participants
66.2 years
STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male
Female
78 Participants
n=5 Participants
74 Participants
n=7 Participants
152 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
16 Participants
n=7 Participants
24 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
82 Participants
n=5 Participants
85 Participants
n=7 Participants
167 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 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
4 Participants
n=5 Participants
8 Participants
n=7 Participants
12 Participants
n=5 Participants
Race (NIH/OMB)
White
75 Participants
n=5 Participants
80 Participants
n=7 Participants
155 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
n=5 Participants
2 Participants
n=7 Participants
6 Participants
n=5 Participants
Region of Enrollment
United States
86 participants
n=5 Participants
90 participants
n=7 Participants
176 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Minutes/week spent in ≥10-min bouts of MVPA

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
18.35 minutes per week
Standard Deviation 24.97
15.54 minutes per week
Standard Deviation 23.94

PRIMARY outcome

Timeframe: Change score: 9 weeks - baseline

Minutes/week spent in ≥10-min bouts of MVPA

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
39.5 minutes per week
Interval 24.5 to 57.5
24.3 minutes per week
Interval 12.6 to 35.7

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

Minutes/week spent in ≥10-min bouts of MVPA

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
28.0 minutes per week
Interval 14.5 to 44.0
16.2 minutes per week
Interval 8.4 to 24.9

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

Minutes/week spent in ≥10-min bouts of MVPA

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
20.7 minutes per week
Interval 10.7 to 32.5
11.3 minutes per week
Interval 3.4 to 20.4

SECONDARY outcome

Timeframe: Baseline

Minutes/week spent in MVPA

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Total Moderate-Vigorous Physical Activity (MVPA)
91.9 minutes per week
Standard Deviation 74.3
93.0 minutes per week
Standard Deviation 95.2

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

Minutes/week spent in MVPA

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Total Moderate-Vigorous Physical Activity (MVPA)
49.2 minutes per week
Interval 29.0 to 69.4
34.4 minutes per week
Interval 14.5 to 54.3

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

Minutes/week spent in MVPA

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Total Moderate-Vigorous Physical Activity (MVPA)
43.0 minutes per week
Interval 23.4 to 62.7
23.1 minutes per week
Interval 3.8 to 42.5

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

Minutes/week spent in MVPA

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Total Moderate-Vigorous Physical Activity (MVPA)
20.6 minutes per week
Interval 1.0 to 40.2
8.8 minutes per week
Interval -10.5 to 28.0

SECONDARY outcome

Timeframe: Baseline

Time spent in sedentary activity

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Sedentary Activity
2804 minutes per week
Standard Deviation 912
2988 minutes per week
Standard Deviation 1069

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

Time spent in sedentary activity

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Sedentary Activity
-85 minutes per week
Interval -256.0 to 85.0
-46 minutes per week
Interval -214.0 to 123.0

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

Time spent in sedentary activity

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Sedentary Activity
-246 minutes per week
Interval -432.0 to -60.0
-209 minutes per week
Interval -392.0 to -26.0

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

Time spent in sedentary activity

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Sedentary Activity
51 minutes per week
Interval -137.0 to 238.0
153 minutes per week
Interval -31.0 to 336.0

SECONDARY outcome

Timeframe: Baseline

Average steps/day over one week

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Average Daily Step Count
3694 steps per day
Standard Deviation 1753
3217 steps per day
Standard Deviation 1595

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

Average steps/day over one week

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Average Daily Step Count
831 steps per day
Interval 479.0 to 1182.0
754 steps per day
Interval 408.0 to 1100.0

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

Average steps/day over one week

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Average Daily Step Count
1100 steps per day
Interval 733.0 to 1467.0
849 steps per day
Interval 488.0 to 1210.0

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

Average steps/day over one week

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Average Daily Step Count
476 steps per day
Interval 111.0 to 842.0
96 steps per day
Interval -263.0 to 455.0

SECONDARY outcome

Timeframe: Baseline

The EQ5D captures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) over 5 levels (no problem, slight problem, moderate problem, severe problem, unable to perform/extreme problem). The scale for the EQ5D ranges from -0.109 to 1, with higher scores indicating higher quality of life.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Quality of Life - Euroqol 5D (EQ5D)
0.89 units on a scale
Standard Deviation 0.12
0.89 units on a scale
Standard Deviation 0.12

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

The EQ5D captures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) over 5 levels (no problem, slight problem, moderate problem, severe problem, unable to perform/extreme problem). The scale for the EQ5D ranges from -0.109 to 1, with higher scores indicating higher quality of life.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Quality of Life - Euroqol 5D (EQ5D)
-0.03 units on a scale
Interval -0.06 to -0.03
-0.05 units on a scale
Interval -0.08 to -0.03

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

The EQ5D captures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) over 5 levels (no problem, slight problem, moderate problem, severe problem, unable to perform/extreme problem). The scale for the EQ5D ranges from -0.109 to 1, with higher scores indicating higher quality of life.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Quality of Life - Euroqol 5D (EQ5D)
-0.06 units on a scale
Interval -0.08 to -0.03
-0.06 units on a scale
Interval -0.09 to -0.04

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

The EQ5D captures five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) over 5 levels (no problem, slight problem, moderate problem, severe problem, unable to perform/extreme problem). The scale for the EQ5D ranges from -0.109 to 1, with higher scores indicating higher quality of life.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Quality of Life - Euroqol 5D (EQ5D)
-0.05 units on a scale
Interval -0.08 to -0.03
-0.07 units on a scale
Interval -0.1 to -0.04

SECONDARY outcome

Timeframe: Baseline

The EuroQol VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. Results are on a 0 to 100 scale with higher scores indicating better self-rated health.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Quality of Life - EuroQol VAS
75.3 units on a scale
Standard Deviation 14.6
74.0 units on a scale
Standard Deviation 13.3

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

The EuroQol VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. Results are on a 0 to 100 scale with higher scores indicating better self-rated health.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Quality of Life - EuroQol VAS
2.1 units on a scale
Interval -0.6 to 4.8
-1.0 units on a scale
Interval -3.6 to 1.7

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

The EuroQol VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. Results are on a 0 to 100 scale with higher scores indicating better self-rated health.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Quality of Life - EuroQol VAS
-0.7 units on a scale
Interval -3.6 to 2.1
-0.9 units on a scale
Interval -3.6 to 1.9

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

The EuroQol VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. Results are on a 0 to 100 scale with higher scores indicating better self-rated health.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Quality of Life - EuroQol VAS
0.0 units on a scale
Interval -2.9 to 2.9
1.1 units on a scale
Interval -1.7 to 3.9

SECONDARY outcome

Timeframe: Baseline

Individuals are asked to rate their confidence in their ability to exercise. Confidence ratings range from 0 (not confident) to 10 (very confident). The average of all responses is used for a total score ranging from 0 to 10. Higher scores indicate higher exercise self-efficacy.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
7.8 units on a scale
Standard Deviation 1.8
7.0 units on a scale
Standard Deviation 2.5

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

Individuals are asked to rate their confidence in their ability to exercise. Confidence ratings range from 0 (not confident) to 10 (very confident). The average of all responses is used for a total score ranging from 0 to 10. Higher scores indicate higher exercise self-efficacy.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
-1.8 units on a scale
Interval -2.3 to -1.3
-1.6 units on a scale
Interval -2.1 to -1.1

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

Individuals are asked to rate their confidence in their ability to exercise. Confidence ratings range from 0 (not confident) to 10 (very confident). The average of all responses is used for a total score ranging from 0 to 10. Higher scores indicate higher exercise self-efficacy.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
-1.8 units on a scale
Interval -2.3 to -1.3
-1.6 units on a scale
Interval -2.1 to -1.1

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

Individuals are asked to rate their confidence in their ability to exercise. Confidence ratings range from 0 (not confident) to 10 (very confident). The average of all responses is used for a total score ranging from 0 to 10. Higher scores indicate higher exercise self-efficacy.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
-2.0 units on a scale
Interval -2.6 to -1.4
-1.8 units on a scale
Interval -2.4 to -1.2

SECONDARY outcome

Timeframe: Baseline

This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise. The OEE-2 includes positive and negative outcome expectations sub-scales. Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
1.6 units on a scale
Standard Deviation 0.5
1.7 units on a scale
Standard Deviation 0.5

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise. The OEE-2 includes positive and negative outcome expectations sub-scales. Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
0.0 units on a scale
Interval -0.1 to 0.1
0.1 units on a scale
Interval 0.0 to 0.2

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise. The OEE-2 includes positive and negative outcome expectations sub-scales. Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
0.0 units on a scale
Interval -0.1 to 0.1
0.1 units on a scale
Interval 0.0 to 0.2

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise. The OEE-2 includes positive and negative outcome expectations sub-scales. Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
0.1 units on a scale
Interval 0.0 to 0.2
0.1 units on a scale
Interval 0.0 to 0.3

SECONDARY outcome

Timeframe: Baseline

This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise. The OEE-2 includes positive and negative outcome expectations sub-scales. Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
1.5 units on a scale
Standard Deviation 0.6
1.8 units on a scale
Standard Deviation 0.6

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise. The OEE-2 includes positive and negative outcome expectations sub-scales. Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
0.2 units on a scale
Interval 0.0 to 0.3
0.1 units on a scale
Interval -0.1 to 0.2

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise. The OEE-2 includes positive and negative outcome expectations sub-scales. Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
0.1 units on a scale
Interval 0.0 to 0.3
0.2 units on a scale
Interval 0.0 to 0.3

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

This is a 13-item instrument focused on beliefs about the positive and negative physical and mental health benefits of exercise. The OEE-2 includes positive and negative outcome expectations sub-scales. Responses range from 1 (strongly agree) to 5 (strongly disagree) and are averaged with final scores ranging from 1 to 5. Lower scores indicate stronger exercise expectations.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
0.2 units on a scale
Interval 0.0 to 0.3
0.2 units on a scale
Interval 0.1 to 0.4

SECONDARY outcome

Timeframe: Baseline

The MAAS scale is comprised of 15 items measured on a 6-point scale (1=almost always, 6=almost never). Responses to individual items are averaged for a total scale ranging from 1 to 6. Higher scores indicate stronger dispositional mindfulness.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Mindfulness - Mindful Attention Awareness Scale (MAAS)
4.2 units on a scale
Standard Deviation 0.9
4.4 units on a scale
Standard Deviation 0.8

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

The MAAS scale is comprised of 15 items measured on a 6-point scale (1=almost always, 6=almost never). Responses to individual items are averaged for a total scale ranging from 1 to 6. Higher scores indicate stronger dispositional mindfulness.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Mindfulness - Mindful Attention Awareness Scale (MAAS)
0.0 units on a scale
Interval -0.1 to 0.1
0.0 units on a scale
Interval -0.2 to 0.1

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

The MAAS scale is comprised of 15 items measured on a 6-point scale (1=almost always, 6=almost never). Responses to individual items are averaged for a total scale ranging from 1 to 6. Higher scores indicate stronger dispositional mindfulness.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Mindfulness - Mindful Attention Awareness Scale (MAAS)
0.2 units on a scale
Interval 0.0 to 0.3
0.1 units on a scale
Interval 0.0 to 0.2

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

The MAAS scale is comprised of 15 items measured on a 6-point scale (1=almost always, 6=almost never). Responses to individual items are averaged for a total scale ranging from 1 to 6. Higher scores indicate stronger dispositional mindfulness.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Mindfulness - Mindful Attention Awareness Scale (MAAS)
0.2 units on a scale
Interval 0.0 to 0.3
0.0 units on a scale
Interval -0.1 to 0.2

SECONDARY outcome

Timeframe: Baseline

The FMI addresses 14 items with a four-point response scale (1=rarely, 4=almost always). Items are summed scores ranging from 14 to 56. Higher scores indicate more mindfulness.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Mindfulness - Frieberg Mindfulness Inventory (FMI)
37.3 units on a scale
Standard Deviation 7.9
38.5 units on a scale
Standard Deviation 7.0

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

The FMI addresses 14 items with a four-point response scale (1=rarely, 4=almost always). Items are summed scores ranging from 14 to 56. Higher scores indicate more mindfulness.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Mindfulness - Frieberg Mindfulness Inventory (FMI)
3.4 units on a scale
Interval 2.2 to 4.6
0.3 units on a scale
Interval -0.9 to 1.4

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

The FMI addresses 14 items with a four-point response scale (1=rarely, 4=almost always). Items are summed scores ranging from 14 to 56. Higher scores indicate more mindfulness.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Mindfulness - Frieberg Mindfulness Inventory (FMI)
3.2 units on a scale
Interval 1.8 to 4.6
1.1 units on a scale
Interval -0.3 to 2.4

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

The FMI addresses 14 items with a four-point response scale (1=rarely, 4=almost always). Items are summed scores ranging from 14 to 56. Higher scores indicate more mindfulness.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Mindfulness - Frieberg Mindfulness Inventory (FMI)
3.5 units on a scale
Interval 2.1 to 5.0
0.7 units on a scale
Interval -0.7 to 2.1

SECONDARY outcome

Timeframe: Baseline

This 8 item scale assesses perceived success in relationships, self-esteem, and purpose. Responses are 7=Strongly Agree to 1=Strongly Disagree. The total score ranges from 8 to 56. Higher scores indicate better perceived wellbeing.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Wellbeing-8-item Flourishing Scale
45.7 units on a scale
Standard Deviation 7.0
46.0 units on a scale
Standard Deviation 6.0

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

This 8 item scale assesses perceived success in relationships, self-esteem, and purpose. Responses are 7=Strongly Agree to 1=Strongly Disagree. The total score ranges from 8 to 56. Higher scores indicate better perceived wellbeing.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Wellbeing-8-item Flourishing Scale
1.3 units on a scale
Interval 0.2 to 2.4
0.3 units on a scale
Interval -0.7 to 1.4

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

This 8 item scale assesses perceived success in relationships, self-esteem, and purpose. Responses are 7=Strongly Agree to 1=Strongly Disagree. The total score ranges from 8 to 56. Higher scores indicate better perceived wellbeing.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Wellbeing-8-item Flourishing Scale
0.8 units on a scale
Interval -0.4 to 2.0
0.6 units on a scale
Interval -0.6 to 1.8

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

This 8 item scale assesses perceived success in relationships, self-esteem, and purpose. Responses are 7=Strongly Agree to 1=Strongly Disagree. The total score ranges from 8 to 56. Higher scores indicate better perceived wellbeing.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Wellbeing-8-item Flourishing Scale
1.3 units on a scale
Interval 0.0 to 2.5
0.1 units on a scale
Interval -1.1 to 1.4

SECONDARY outcome

Timeframe: Baseline

Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree. Items are summed with the total scale ranging from 8 to 48. Higher scores indicates more social connectedness.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Social Connectedness
40.1 units on a scale
Standard Deviation 7.5
41.7 units on a scale
Standard Deviation 6.5

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree. Items are summed with the total scale ranging from 8 to 48. Higher scores indicates more social connectedness.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Social Connectedness
1.4 units on a scale
Interval 0.1 to 2.7
-0.6 units on a scale
Interval -1.9 to 0.7

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree. Items are summed with the total scale ranging from 8 to 48. Higher scores indicates more social connectedness.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Social Connectedness
1.0 units on a scale
Interval -0.5 to 2.4
-1.1 units on a scale
Interval -2.5 to 0.3

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree. Items are summed with the total scale ranging from 8 to 48. Higher scores indicates more social connectedness.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Social Connectedness
1.2 units on a scale
Interval -0.3 to 2.7
-0.9 units on a scale
Interval -2.3 to 0.5

SECONDARY outcome

Timeframe: Baseline

Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree. Items are summed with the total scale ranging from 8 to 48. Higher scores indicates more social assuredness or confidence.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Social Assuredness
38.9 units on a scale
Standard Deviation 5.8
36.8 units on a scale
Standard Deviation 6.4

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree. Items are summed with the total scale ranging from 8 to 48. Higher scores indicates more social assuredness or confidence.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Social Assuredness
1.1 units on a scale
Interval -0.1 to 2.4
1.5 units on a scale
Interval 0.3 to 2.7

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree. Items are summed with the total scale ranging from 8 to 48. Higher scores indicates more social assuredness or confidence.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Social Assuredness
1.1 units on a scale
Interval -0.1 to 2.4
1.1 units on a scale
Interval -0.2 to 2.3

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

Eight-item questionnaire with responses ranging from 1=strongly agree to 6=strongly disagree. Items are summed with the total scale ranging from 8 to 48. Higher scores indicates more social assuredness or confidence.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Social Assuredness
0.9 units on a scale
Interval -0.4 to 2.2
1.8 units on a scale
Interval 0.6 to 3.0

SECONDARY outcome

Timeframe: Baseline

Self-reported MVPA in bouts of 10 minutes or higher was measured using questions adapted from the International Physical Activity Questionnaire (IPAQ). The IPAQ is a nine-item instrument addressing days/week and minutes/day spent on physical activity in the past 7 days.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Physical Activity-International Physical Activity Questionnaire (IPAQ)
61.8 minutes per week
Standard Deviation 58.6
65.6 minutes per week
Standard Deviation 87.5

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

Self-reported MVPA in bouts of 10 minutes or higher was measured using questions adapted from the International Physical Activity Questionnaire (IPAQ). The IPAQ is a nine-item instrument addressing days/week and minutes/day spent on physical activity in the past 7 days.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Physical Activity-International Physical Activity Questionnaire (IPAQ)
89.6 minutes per week
Interval 54.3 to 124.8
42.7 minutes per week
Interval 8.2 to 77.1

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

Self-reported MVPA in bouts of 10 minutes or higher was measured using questions adapted from the International Physical Activity Questionnaire (IPAQ). The IPAQ is a nine-item instrument addressing days/week and minutes/day spent on physical activity in the past 7 days.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Physical Activity-International Physical Activity Questionnaire (IPAQ)
91.0 minutes per week
Interval 55.7 to 126.3
60.2 minutes per week
Interval 25.9 to 94.6

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

Self-reported MVPA in bouts of 10 minutes or higher was measured using questions adapted from the International Physical Activity Questionnaire (IPAQ). The IPAQ is a nine-item instrument addressing days/week and minutes/day spent on physical activity in the past 7 days.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Physical Activity-International Physical Activity Questionnaire (IPAQ)
30.5 minutes per week
Interval -5.4 to 66.5
28.4 minutes per week
Interval -6.2 to 63.0

SECONDARY outcome

Timeframe: 9 weeks

Participants will rate their overall satisfaction with the intervention on 7 point scale (7=completely satisfied, 1= completely dissatisfied).

Outcome measures

Outcome measures
Measure
Mindful Movement
n=83 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=87 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Satisfaction With Intervention
2.2 units on a scale
Interval 1.9 to 2.5
2.7 units on a scale
Interval 2.4 to 3.0

SECONDARY outcome

Timeframe: 26 weeks

Participants will rate their overall satisfaction with the intervention on 7 point scale (7=completely satisfied, 1= completely dissatisfied).

Outcome measures

Outcome measures
Measure
Mindful Movement
n=83 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=87 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Satisfaction With Intervention
2.3 units on a scale
Interval 2.0 to 2.6
2.6 units on a scale
Interval 2.3 to 2.9

SECONDARY outcome

Timeframe: 52 weeks

Participants will rate their overall satisfaction with the intervention on 7 point scale (7=completely satisfied, 1= completely dissatisfied).

Outcome measures

Outcome measures
Measure
Mindful Movement
n=83 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=87 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Satisfaction With Intervention
2.4 units on a scale
Interval 2.1 to 2.7
2.5 units on a scale
Interval 2.3 to 2.8

SECONDARY outcome

Timeframe: 9 weeks

Participants will report the number of days per week they were able to practice skills taught in the program

Outcome measures

Outcome measures
Measure
Mindful Movement
n=83 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=87 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Frequency of Home Practice
4.3 days per week
Interval 3.8 to 4.8
3.4 days per week
Interval 2.9 to 3.9

SECONDARY outcome

Timeframe: 26 weeks

Participants will report the number of days per week they were able to practice skills taught in the program

Outcome measures

Outcome measures
Measure
Mindful Movement
n=83 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=87 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Frequency of Home Practice
3.1 days per week
Interval 2.6 to 3.5
3.0 days per week
Interval 2.5 to 3.4

SECONDARY outcome

Timeframe: 52 weeks

Participants will report the number of days per week they were able to practice skills taught in the program

Outcome measures

Outcome measures
Measure
Mindful Movement
n=83 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=87 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Frequency of Home Practice
3.2 days per week
Interval 2.7 to 3.7
2.5 days per week
Interval 2.1 to 3.0

SECONDARY outcome

Timeframe: Baseline

An 11-box numerical rating scale (0=no pain, 10 = worst pain possible) for average back, neck, upper extremity, and lower extremity pain in the past week. The highest score for the assessed body regions was used for analysis.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Pain-11 Box Numerical Rating Scale
3.4 units on a scale
Standard Deviation 2.3
3.3 units on a scale
Standard Deviation 2.4

SECONDARY outcome

Timeframe: Change score: 9 weeks - baseline

An 11-box numerical rating scale (0=no pain, 10 = worst pain possible) for average back, neck, upper extremity, and lower extremity pain in the past week. The highest score for the assessed body regions was used for analysis.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Pain-11 Box Numerical Rating Scale
0.4 units on a scale
Interval -0.1 to 0.9
1.0 units on a scale
Interval 0.5 to 1.4

SECONDARY outcome

Timeframe: Change score: 26 weeks - baseline

An 11-box numerical rating scale (0=no pain, 10 = worst pain possible) for average back, neck, upper extremity, and lower extremity pain in the past week. The highest score for the assessed body regions was used for analysis.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Pain-11 Box Numerical Rating Scale
0.9 units on a scale
Interval 0.4 to 1.4
0.8 units on a scale
Interval 0.3 to 1.2

SECONDARY outcome

Timeframe: Change score: 52 weeks - baseline

An 11-box numerical rating scale (0=no pain, 10 = worst pain possible) for average back, neck, upper extremity, and lower extremity pain in the past week. The highest score for the assessed body regions was used for analysis.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Pain-11 Box Numerical Rating Scale
1.0 units on a scale
Interval 0.5 to 1.4
0.7 units on a scale
Interval 0.2 to 1.2

SECONDARY outcome

Timeframe: 9 weeks

Participant views of the remote intervention platform (Zoom video-conferencing system) were assessed using the Telehealth Usability Questionnaire (TUQ). The TUQ assesses usability with 21 questions rated on a 1 to 7 scale. The overall score is an average of all items with higher scores indicating higher usability of the telehealth system.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=45 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=43 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Telehealth Usability Questionnaire
6.1 units on a scale
Standard Deviation 0.7
5.9 units on a scale
Standard Deviation 0.8

SECONDARY outcome

Timeframe: 9 weeks

Question from the WAI bond sub-scale asking participants how often they felt uncomfortable with the facilitators. Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always. A lower score indicates a higher bond with the facilitator.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=46 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=43 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Working Alliance Inventory (WAI)
2.9 units on a scale
Standard Deviation 2.6
1.9 units on a scale
Standard Deviation 2.0

SECONDARY outcome

Timeframe: 9 weeks

Question from the WAI bond sub-scale asking participants how often they felt uncomfortable with certain participants in the group. Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always. A lower score indicates a higher bond with the group.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=46 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=43 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Working Alliance Inventory (WAI)
1.7 units on a scale
Standard Deviation 1.4
2.0 units on a scale
Standard Deviation 1.2

SECONDARY outcome

Timeframe: 9 weeks

Question from the WAI task sub-scale asking participants how often they felt confused by what they were being asked to do in the sessions. Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always. A lower score indicates a higher task alliance with the facilitator.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=46 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=43 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Working Alliance Inventory (WAI)
1.7 units on a scale
Standard Deviation 1.1
2.0 units on a scale
Standard Deviation 1.2

SECONDARY outcome

Timeframe: 9 weeks

Question from the WAI bond sub-scale asking participants how often they felt the facilitators liked them. Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always. A higher score indicates a higher bond with the facilitator.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=45 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=43 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Working Alliance Inventory (WAI)
5.8 units on a scale
Standard Deviation 1.6
6.0 units on a scale
Standard Deviation 1.5

SECONDARY outcome

Timeframe: 9 weeks

Question from the WAI bond sub-scale asking participants how often they felt the facilitators were genuinely concerned for their welfare. Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always. A higher score indicates a higher bond with the facilitator.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=45 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=43 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Working Alliance Inventory (WAI)
6.7 units on a scale
Standard Deviation 0.8
6.6 units on a scale
Standard Deviation 0.8

SECONDARY outcome

Timeframe: 9 weeks

Question from the WAI bond sub-scale asking participants how often they felt the facilitators respected them. Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always. A higher score indicates a higher bond with the facilitator.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=46 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=43 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Working Alliance Inventory (WAI)
6.6 units on a scale
Standard Deviation 0.9
6.8 units on a scale
Standard Deviation 0.7

SECONDARY outcome

Timeframe: 9 weeks

Question from the WAI bond sub-scale asking participants how often they felt the facilitators appreciated them. Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always. A higher score indicates a higher bond with the facilitator.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=45 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=43 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Working Alliance Inventory (WAI)
6.2 units on a scale
Standard Deviation 1.3
6.2 units on a scale
Standard Deviation 1.5

SECONDARY outcome

Timeframe: 9 weeks

Question from the WAI bond sub-scale asking participants how often they felt confident the facilitators could help them if needed. Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always. A higher score indicates a higher bond with the facilitator.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=46 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=43 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Working Alliance Inventory (WAI)
6.4 units on a scale
Standard Deviation 1.1
6.4 units on a scale
Standard Deviation 1.2

SECONDARY outcome

Timeframe: 9 weeks

Question from the WAI bond sub-scale asking participants how often they felt their relationship with the facilitators was very important to them. Responses were recorded on a 1 to 7 scale with 1= Never and 7 = Always. A higher score indicates a higher bond with the facilitator.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=45 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=43 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Working Alliance Inventory (WAI)
5.0 units on a scale
Standard Deviation 1.9
5.3 units on a scale
Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline

Impact of COVID-19 on physical activity was assessed on a 5-item scale (1= substantially less physically active to 5 = substantially more physically active). The number of participants with reduced physical activity due to COVID-19 is reported.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=47 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=45 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Covid -19 Impact on Physical Activity
42 Participants
42 Participants

SECONDARY outcome

Timeframe: 9 weeks

Impact of COVID-19 on physical activity was assessed on a 5-item scale (1= substantially less physically active to 5 = substantially more physically active). The number of participants with reduced physical activity due to COVID-19 is reported.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=69 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=70 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Covid -19 Impact on Physical Activity
54 Participants
52 Participants

SECONDARY outcome

Timeframe: 26 weeks

Impact of COVID-19 on physical activity was assessed on a 5-item scale (1= substantially less physically active to 5 = substantially more physically active). The number of participants with reduced physical activity due to COVID-19 is reported.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=68 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=70 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Covid -19 Impact on Physical Activity
49 Participants
49 Participants

SECONDARY outcome

Timeframe: 52 weeks

Impact of COVID-19 on physical activity was assessed on a 5-item scale (1= substantially less physically active to 5 = substantially more physically active). The number of participants with reduced physical activity due to COVID-19 is reported.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=77 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=85 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Covid -19 Impact on Physical Activity
64 Participants
67 Participants

SECONDARY outcome

Timeframe: 9 weeks

The number of participants completing qualitative, open ended assessments exploring dislikes and barriers to participation in the intervention.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Number of Participants Completing Qualitative Assessment of Barriers to Intervention
83 Participants
84 Participants

SECONDARY outcome

Timeframe: 9 weeks

The number of participants completing qualitative, open ended assessment exploring likes and facilitators to participation in the intervention.

Outcome measures

Outcome measures
Measure
Mindful Movement
n=86 Participants
8, 90-minute, in-person, group sessions over 8 weeks The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception by providing opportunities for education, practice, and social support.
Keys to Health & Wellbeing
n=90 Participants
8, 90-minute, in-person, group sessions over 8 weeks This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Number of Participants Completing Qualitative Assessment of Facilitators to Intervention
83 Participants
84 Participants

Adverse Events

Mindful Movement

Serious events: 7 serious events
Other events: 40 other events
Deaths: 1 deaths

Keys to Health & Wellbeing

Serious events: 6 serious events
Other events: 51 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Mindful Movement
n=86 participants at risk
8, 90-minute, in-person, group sessions over 8 weeks Mindful Movement: The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception, by providing opportunities for education, practice, and social suppo
Keys to Health & Wellbeing
n=90 participants at risk
8, 90-minute, in-person, group sessions over 8 weeks Keys to Health \& Wellbeing: This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Cardiac disorders
Cardiac conditions (e.g., atrial fibrillation, heart failure)
1.2%
1/86 • Number of events 1 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
2.2%
2/90 • Number of events 2 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
Vascular disorders
Hospitalization: Pseudosepsis
1.2%
1/86 • Number of events 1 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
0.00%
0/90 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
Infections and infestations
Hospitalization: Infection (COVID-19 or other)
0.00%
0/86 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
1.1%
1/90 • Number of events 1 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
Vascular disorders
Stroke
1.2%
1/86 • Number of events 1 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
1.1%
1/90 • Number of events 1 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
Renal and urinary disorders
Hospitalization: Renal or Urinary disease
0.00%
0/86 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
1.1%
1/90 • Number of events 1 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
1.2%
1/86 • Number of events 1 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
0.00%
0/90 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
Musculoskeletal and connective tissue disorders
Hospitalization: Fracture or Dislocation
2.3%
2/86 • Number of events 2 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
0.00%
0/90 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
Musculoskeletal and connective tissue disorders
Hospitalization: Joint Replacement
1.2%
1/86 • Number of events 1 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
0.00%
0/90 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
Nervous system disorders
Hospitalization: Vertigo or Syncope
1.2%
1/86 • Number of events 1 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
0.00%
0/90 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
Metabolism and nutrition disorders
Amyloidosis
0.00%
0/86 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
1.1%
1/90 • Number of events 1 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.

Other adverse events

Other adverse events
Measure
Mindful Movement
n=86 participants at risk
8, 90-minute, in-person, group sessions over 8 weeks Mindful Movement: The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception, by providing opportunities for education, practice, and social suppo
Keys to Health & Wellbeing
n=90 participants at risk
8, 90-minute, in-person, group sessions over 8 weeks Keys to Health \& Wellbeing: This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
Musculoskeletal and connective tissue disorders
Increased pain
24.4%
21/86 • Number of events 23 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
26.7%
24/90 • Number of events 26 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
Psychiatric disorders
Increased sadness, anxiousness, loneliness, or disturbing memories
20.9%
18/86 • Number of events 20 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
20.0%
18/90 • Number of events 18 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
General disorders
Increased fatigue
3.5%
3/86 • Number of events 3 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
5.6%
5/90 • Number of events 5 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
Infections and infestations
Infection (COVID-19 or other)
11.6%
10/86 • Number of events 10 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
17.8%
16/90 • Number of events 18 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
Nervous system disorders
Vertigo or Syncope
2.3%
2/86 • Number of events 2 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.
5.6%
5/90 • Number of events 6 • Adverse events were collected over the 1 year trial period.
Adverse events (AEs) were monitored using active and passive surveillance. Participants were asked about the occurrence of potential AEs during all visits and surveys. In addition, participants were instructed to report adverse events to staff if they occurred. An independent safety monitor from the DSMB was responsible for classifying adverse events. Except for death, only adverse events classified as possibly, probably, or definitely related to the interventions are reported.

Additional Information

Brent Leininger

University of Minnesota

Phone: (612) 626-6477

Results disclosure agreements

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