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

July 12, 2023 updated by: University of Minnesota

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

Physical inactivity has reached pandemic proportions and is associated with increased morbidity, mortality, and healthcare costs. Of particular concern is that most middle to older age adults fall far short of recommendations for health enhancing physical activities. This research takes a novel approach to tackling this problem by combining mindfulness with behavioral strategies in a unique 'Mindful Movement' program offered collaboratively with the YMCA.

Study Overview

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • YMCA Burnsville
      • Edina, Minnesota, United States, 55435
        • YMCA Southdale
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55405
        • YMCA Cora McCorvey
      • Saint Paul, Minnesota, United States, 55104
        • YMCA Midway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

≥ 50 years of age

  • Accelerometer wear time ≥10 hours on at least 4 days in a 7 consecutive day period between baselines
  • Self-report of <140 minutes of MVPA per week in 3 months prior to baseline AND accelerometer recorded <100 minutes of MVPA between baselines
  • Mini-Mental State score ≥ 24 if indicated
  • Independent self-ambulation
  • Provides consent and is willing to participate in data collection activities

Exclusion Criteria:

  • Pregnancy
  • Unwilling or unable to participate in study activities
  • Current or upcoming participation in educational programs similar to those under study
  • Medical restrictions to increasing Moderate Vigorous Physical Activity (MVPA)
  • Terminal illness
  • Contraindications to mindfulness practice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 suppo
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Time Frame: Baseline
Minutes/week spent in ≥10-min bouts of MVPA
Baseline
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Time Frame: Change score: 9 weeks - baseline
Minutes/week spent in ≥10-min bouts of MVPA
Change score: 9 weeks - baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Time Frame: Change score: 26 weeks - baseline
Minutes/week spent in ≥10-min bouts of MVPA
Change score: 26 weeks - baseline
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Time Frame: Change score: 52 weeks - baseline
Minutes/week spent in ≥10-min bouts of MVPA
Change score: 52 weeks - baseline
Total Moderate-Vigorous Physical Activity (MVPA)
Time Frame: Baseline
Minutes/week spent in MVPA
Baseline
Total Moderate-Vigorous Physical Activity (MVPA)
Time Frame: Change score: 9 weeks - baseline
Minutes/week spent in MVPA
Change score: 9 weeks - baseline
Total Moderate-Vigorous Physical Activity (MVPA)
Time Frame: Change score: 26 weeks - baseline
Minutes/week spent in MVPA
Change score: 26 weeks - baseline
Total Moderate-Vigorous Physical Activity (MVPA)
Time Frame: Change score: 52 weeks - baseline
Minutes/week spent in MVPA
Change score: 52 weeks - baseline
Sedentary Activity
Time Frame: Baseline
Time spent in sedentary activity
Baseline
Sedentary Activity
Time Frame: Change score: 9 weeks - baseline
Time spent in sedentary activity
Change score: 9 weeks - baseline
Sedentary Activity
Time Frame: Change score: 26 weeks - baseline
Time spent in sedentary activity
Change score: 26 weeks - baseline
Sedentary Activity
Time Frame: Change score: 52 weeks - baseline
Time spent in sedentary activity
Change score: 52 weeks - baseline
Average Daily Step Count
Time Frame: Baseline
Average steps/day over one week
Baseline
Average Daily Step Count
Time Frame: Change score: 9 weeks - baseline
Average steps/day over one week
Change score: 9 weeks - baseline
Average Daily Step Count
Time Frame: Change score: 26 weeks - baseline
Average steps/day over one week
Change score: 26 weeks - baseline
Average Daily Step Count
Time Frame: Change score: 52 weeks - baseline
Average steps/day over one week
Change score: 52 weeks - baseline
Quality of Life - Euroqol 5D (EQ5D)
Time Frame: 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.
Baseline
Quality of Life - Euroqol 5D (EQ5D)
Time Frame: 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.
Change score: 9 weeks - baseline
Quality of Life - Euroqol 5D (EQ5D)
Time Frame: 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.
Change score: 26 weeks - baseline
Quality of Life - Euroqol 5D (EQ5D)
Time Frame: 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.
Change score: 52 weeks - baseline
Quality of Life - EuroQol VAS
Time Frame: 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.
Baseline
Quality of Life - EuroQol VAS
Time Frame: 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.
Change score: 9 weeks - baseline
Quality of Life - EuroQol VAS
Time Frame: 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.
Change score: 26 weeks - baseline
Quality of Life - EuroQol VAS
Time Frame: 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.
Change score: 52 weeks - baseline
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
Time Frame: 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.
Baseline
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
Time Frame: 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.
Change score: 9 weeks - baseline
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
Time Frame: 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.
Change score: 26 weeks - baseline
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
Time Frame: 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.
Change score: 52 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
Time Frame: 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.
Baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
Time Frame: 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.
Change score: 9 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
Time Frame: 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.
Change score: 26 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
Time Frame: 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.
Change score: 52 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
Time Frame: 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.
Baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
Time Frame: 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.
Change score: 9 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
Time Frame: 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.
Change score: 26 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
Time Frame: 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.
Change score: 52 weeks - baseline
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Time Frame: 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.
Baseline
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Time Frame: 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.
Change score: 9 weeks - baseline
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Time Frame: 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.
Change score: 26 weeks - baseline
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Time Frame: 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.
Change score: 52 weeks - baseline
Mindfulness - Frieberg Mindfulness Inventory (FMI)
Time Frame: 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.
Baseline
Mindfulness - Frieberg Mindfulness Inventory (FMI)
Time Frame: 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.
Change score: 9 weeks - baseline
Mindfulness - Frieberg Mindfulness Inventory (FMI)
Time Frame: 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.
Change score: 26 weeks - baseline
Mindfulness - Frieberg Mindfulness Inventory (FMI)
Time Frame: 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.
Change score: 52 weeks - baseline
Wellbeing-8-item Flourishing Scale
Time Frame: 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.
Baseline
Wellbeing-8-item Flourishing Scale
Time Frame: 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.
Change score: 9 weeks - baseline
Wellbeing-8-item Flourishing Scale
Time Frame: 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.
Change score: 26 weeks - baseline
Wellbeing-8-item Flourishing Scale
Time Frame: 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.
Change score: 52 weeks - baseline
Social Connectedness
Time Frame: 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.
Baseline
Social Connectedness
Time Frame: 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.
Change score: 9 weeks - baseline
Social Connectedness
Time Frame: 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.
Change score: 26 weeks - baseline
Social Connectedness
Time Frame: 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.
Change score: 52 weeks - baseline
Social Assuredness
Time Frame: 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.
Baseline
Social Assuredness
Time Frame: 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.
Change score: 9 weeks - baseline
Social Assuredness
Time Frame: 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.
Change score: 26 weeks - baseline
Social Assuredness
Time Frame: 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.
Change score: 52 weeks - baseline
Physical Activity-International Physical Activity Questionnaire (IPAQ)
Time Frame: 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.
Baseline
Physical Activity-International Physical Activity Questionnaire (IPAQ)
Time Frame: 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.
Change score: 9 weeks - baseline
Physical Activity-International Physical Activity Questionnaire (IPAQ)
Time Frame: 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.
Change score: 26 weeks - baseline
Physical Activity-International Physical Activity Questionnaire (IPAQ)
Time Frame: 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.
Change score: 52 weeks - baseline
Satisfaction With Intervention
Time Frame: 9 weeks
Participants will rate their overall satisfaction with the intervention on 7 point scale (7=completely satisfied, 1= completely dissatisfied).
9 weeks
Satisfaction With Intervention
Time Frame: 26 weeks
Participants will rate their overall satisfaction with the intervention on 7 point scale (7=completely satisfied, 1= completely dissatisfied).
26 weeks
Satisfaction With Intervention
Time Frame: 52 weeks
Participants will rate their overall satisfaction with the intervention on 7 point scale (7=completely satisfied, 1= completely dissatisfied).
52 weeks
Frequency of Home Practice
Time Frame: 9 weeks
Participants will report the number of days per week they were able to practice skills taught in the program
9 weeks
Frequency of Home Practice
Time Frame: 26 weeks
Participants will report the number of days per week they were able to practice skills taught in the program
26 weeks
Frequency of Home Practice
Time Frame: 52 weeks
Participants will report the number of days per week they were able to practice skills taught in the program
52 weeks
Pain-11 Box Numerical Rating Scale
Time Frame: 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.
Baseline
Pain-11 Box Numerical Rating Scale
Time Frame: 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.
Change score: 9 weeks - baseline
Pain-11 Box Numerical Rating Scale
Time Frame: 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.
Change score: 26 weeks - baseline
Pain-11 Box Numerical Rating Scale
Time Frame: 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.
Change score: 52 weeks - baseline
Telehealth Usability Questionnaire
Time Frame: 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.
9 weeks
Working Alliance Inventory (WAI)
Time Frame: 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.
9 weeks
Working Alliance Inventory (WAI)
Time Frame: 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.
9 weeks
Working Alliance Inventory (WAI)
Time Frame: 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.
9 weeks
Working Alliance Inventory (WAI)
Time Frame: 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.
9 weeks
Working Alliance Inventory (WAI)
Time Frame: 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.
9 weeks
Working Alliance Inventory (WAI)
Time Frame: 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.
9 weeks
Working Alliance Inventory (WAI)
Time Frame: 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.
9 weeks
Working Alliance Inventory (WAI)
Time Frame: 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.
9 weeks
Working Alliance Inventory (WAI)
Time Frame: 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.
9 weeks
Covid -19 Impact on Physical Activity
Time Frame: 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.
Baseline
Covid -19 Impact on Physical Activity
Time Frame: 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.
9 weeks
Covid -19 Impact on Physical Activity
Time Frame: 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.
26 weeks
Covid -19 Impact on Physical Activity
Time Frame: 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.
52 weeks
Number of Participants Completing Qualitative Assessment of Barriers to Intervention
Time Frame: 9 weeks
The number of participants completing qualitative, open ended assessments exploring dislikes and barriers to participation in the intervention.
9 weeks
Number of Participants Completing Qualitative Assessment of Facilitators to Intervention
Time Frame: 9 weeks
The number of participants completing qualitative, open ended assessment exploring likes and facilitators to participation in the intervention.
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2019

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (Actual)

April 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1611S99323
  • R33AT009110 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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