Physical InactivtyY-UNCT03929393
Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Hybrid Effectiveness-Implementation Study
A study testing Mindful Movement and Keys to Health & Wellbeing in people with Physical Inactivty and Wellbeing, run by University of Minnesota at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivty, Wellbeing, Mindfulness
- What is being tested?
- Mindful Movement and Keys to Health & Wellbeing
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Jul 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
YMCA Burnsville
Burnsville, Minnesota, 55337
YMCA Southdale
Edina, Minnesota, 55435
YMCA Cora McCorvey
Minneapolis, Minnesota, 55405
University of Minnesota
Minneapolis, Minnesota, 55455
YMCA Midway
Saint Paul, Minnesota, 55104
About this study
Official title: 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.
- Conditions
- Physical Inactivty, Wellbeing, Mindfulness
- Being tested
- Mindful Movement, Keys to Health & Wellbeing
- Keywords
- Randomized controlled trial, Exercise, Physical Activity, Behavior Change, Mindfulness, Aging
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful MovementBehavioural
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 & WellbeingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Movement | Experimental | 8, 90-minute, in-person, group sessions over 8 weeks Receives: Behavioral: Mindful Movement |
| Keys to Health & Wellbeing | Active comparator | 8, 90-minute, in-person, group sessions over 8 weeks Receives: Other: Keys to Health & Wellbeing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Minutes/week spent in ≥10-min bouts of MVPA
Measured: Baseline
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Minutes/week spent in ≥10-min bouts of MVPA
Measured: Change score: 9 weeks - baseline
Secondary outcomes (84)
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Minutes/week spent in ≥10-min bouts of MVPA
Measured: Change score: 26 weeks - baseline
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Minutes/week spent in ≥10-min bouts of MVPA
Measured: Change score: 52 weeks - baseline
Total Moderate-Vigorous Physical Activity (MVPA)
Minutes/week spent in MVPA
Measured: Baseline
Total Moderate-Vigorous Physical Activity (MVPA)
Minutes/week spent in MVPA
Measured: Change score: 9 weeks - baseline
Total Moderate-Vigorous Physical Activity (MVPA)
Minutes/week spent in MVPA
Measured: Change score: 26 weeks - baseline
Total Moderate-Vigorous Physical Activity (MVPA)
Minutes/week spent in MVPA
Measured: Change score: 52 weeks - baseline
Sedentary Activity
Time spent in sedentary activity
Measured: Baseline
Sedentary Activity
Time spent in sedentary activity
Measured: Change score: 9 weeks - baseline
Sedentary Activity
Time spent in sedentary activity
Measured: Change score: 26 weeks - baseline
Sedentary Activity
Time spent in sedentary activity
Measured: Change score: 52 weeks - baseline
Average Daily Step Count
Average steps/day over one week
Measured: Baseline
Average Daily Step Count
Average steps/day over one week
Measured: Change score: 9 weeks - baseline
Average Daily Step Count
Average steps/day over one week
Measured: Change score: 26 weeks - baseline
Average Daily Step Count
Average steps/day over one week
Measured: Change score: 52 weeks - baseline
Quality of Life - Euroqol 5D (EQ5D)
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.
Measured: Baseline
Quality of Life - Euroqol 5D (EQ5D)
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.
Measured: Change score: 9 weeks - baseline
Quality of Life - Euroqol 5D (EQ5D)
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.
Measured: Change score: 26 weeks - baseline
Quality of Life - Euroqol 5D (EQ5D)
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.
Measured: Change score: 52 weeks - baseline
Quality of Life - EuroQol VAS
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.
Measured: Baseline
Quality of Life - EuroQol VAS
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.
Measured: Change score: 9 weeks - baseline
Quality of Life - EuroQol VAS
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.
Measured: Change score: 26 weeks - baseline
Quality of Life - EuroQol VAS
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.
Measured: Change score: 52 weeks - baseline
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
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.
Measured: Baseline
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
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.
Measured: Change score: 9 weeks - baseline
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
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.
Measured: Change score: 26 weeks - baseline
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
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.
Measured: Change score: 52 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
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.
Measured: Baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
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.
Measured: Change score: 9 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
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.
Measured: Change score: 26 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
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.
Measured: Change score: 52 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
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.
Measured: Baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
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.
Measured: Change score: 9 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
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.
Measured: Change score: 26 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
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.
Measured: Change score: 52 weeks - baseline
Mindfulness - Mindful Attention Awareness Scale (MAAS)
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.
Measured: Baseline
Mindfulness - Mindful Attention Awareness Scale (MAAS)
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.
Measured: Change score: 9 weeks - baseline
Mindfulness - Mindful Attention Awareness Scale (MAAS)
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.
Measured: Change score: 26 weeks - baseline
Mindfulness - Mindful Attention Awareness Scale (MAAS)
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.
Measured: Change score: 52 weeks - baseline
Mindfulness - Frieberg Mindfulness Inventory (FMI)
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.
Measured: Baseline
Mindfulness - Frieberg Mindfulness Inventory (FMI)
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.
Measured: Change score: 9 weeks - baseline
Mindfulness - Frieberg Mindfulness Inventory (FMI)
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.
Measured: Change score: 26 weeks - baseline
Mindfulness - Frieberg Mindfulness Inventory (FMI)
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.
Measured: Change score: 52 weeks - baseline
Wellbeing-8-item Flourishing Scale
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.
Measured: Baseline
Wellbeing-8-item Flourishing Scale
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.
Measured: Change score: 9 weeks - baseline
Wellbeing-8-item Flourishing Scale
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.
Measured: Change score: 26 weeks - baseline
Wellbeing-8-item Flourishing Scale
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.
Measured: Change score: 52 weeks - baseline
Social Connectedness
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.
Measured: Baseline
Social Connectedness
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.
Measured: Change score: 9 weeks - baseline
Social Connectedness
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.
Measured: Change score: 26 weeks - baseline
Social Connectedness
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.
Measured: Change score: 52 weeks - baseline
Social Assuredness
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.
Measured: Baseline
Social Assuredness
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.
Measured: Change score: 9 weeks - baseline
Social Assuredness
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.
Measured: Change score: 26 weeks - baseline
Social Assuredness
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.
Measured: Change score: 52 weeks - baseline
Physical Activity-International Physical Activity Questionnaire (IPAQ)
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.
Measured: Baseline
Physical Activity-International Physical Activity Questionnaire (IPAQ)
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.
Measured: Change score: 9 weeks - baseline
Physical Activity-International Physical Activity Questionnaire (IPAQ)
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.
Measured: Change score: 26 weeks - baseline
Physical Activity-International Physical Activity Questionnaire (IPAQ)
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.
Measured: Change score: 52 weeks - baseline
Satisfaction With Intervention
Participants will rate their overall satisfaction with the intervention on 7 point scale (7=completely satisfied, 1= completely dissatisfied).
Measured: 9 weeks
Satisfaction With Intervention
Participants will rate their overall satisfaction with the intervention on 7 point scale (7=completely satisfied, 1= completely dissatisfied).
Measured: 26 weeks
Satisfaction With Intervention
Participants will rate their overall satisfaction with the intervention on 7 point scale (7=completely satisfied, 1= completely dissatisfied).
Measured: 52 weeks
Frequency of Home Practice
Participants will report the number of days per week they were able to practice skills taught in the program
Measured: 9 weeks
Frequency of Home Practice
Participants will report the number of days per week they were able to practice skills taught in the program
Measured: 26 weeks
Frequency of Home Practice
Participants will report the number of days per week they were able to practice skills taught in the program
Measured: 52 weeks
Pain-11 Box Numerical Rating Scale
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.
Measured: Baseline
Pain-11 Box Numerical Rating Scale
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.
Measured: Change score: 9 weeks - baseline
Pain-11 Box Numerical Rating Scale
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.
Measured: Change score: 26 weeks - baseline
Pain-11 Box Numerical Rating Scale
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.
Measured: Change score: 52 weeks - baseline
Telehealth Usability Questionnaire
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.
Measured: 9 weeks
Working Alliance Inventory (WAI)
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.
Measured: 9 weeks
Working Alliance Inventory (WAI)
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.
Measured: 9 weeks
Working Alliance Inventory (WAI)
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.
Measured: 9 weeks
Working Alliance Inventory (WAI)
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.
Measured: 9 weeks
Working Alliance Inventory (WAI)
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.
Measured: 9 weeks
Working Alliance Inventory (WAI)
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.
Measured: 9 weeks
Working Alliance Inventory (WAI)
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.
Measured: 9 weeks
Working Alliance Inventory (WAI)
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.
Measured: 9 weeks
Working Alliance Inventory (WAI)
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.
Measured: 9 weeks
Covid -19 Impact on Physical Activity
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.
Measured: Baseline
Covid -19 Impact on Physical Activity
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.
Measured: 9 weeks
Covid -19 Impact on Physical Activity
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.
Measured: 26 weeks
Covid -19 Impact on Physical Activity
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.
Measured: 52 weeks
Number of Participants Completing Qualitative Assessment of Barriers to Intervention
The number of participants completing qualitative, open ended assessments exploring dislikes and barriers to participation in the intervention.
Measured: 9 weeks
Number of Participants Completing Qualitative Assessment of Facilitators to Intervention
The number of participants completing qualitative, open ended assessment exploring likes and facilitators to participation in the intervention.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start17 Jul 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Physical InactivtyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- YMCA, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929393
- Sponsor's protocol ID
- 1611S99323
- Other IDs
- R33AT009110
- Acronym
- Y-U
- Status last verified
- Jul 2023
- First submitted
- 16 Apr 2019
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Movement for Physical Activity and Wellbeing in Older Adults- A Community Based Randomized Hybrid Effectiveness-Implementation Study
- ClinicalTrials.gov ID
- NCT03929393
- Acronym / sponsor ID
- Y-U / 1611S99323
- Conditions
- Physical Inactivty, Wellbeing, Mindfulness
- Keywords
- Randomized controlled trial, Exercise, Physical Activity, Behavior Change, Mindfulness, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- YMCA, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Posted 21 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Movement | Experimental | Behavioral: Mindful Movement8, 90-minute, in-person, group sessions over 8 weeks |
| Keys to Health & Wellbeing | Active comparator | Other: Keys to Health & Wellbeing8, 90-minute, in-person, group sessions over 8 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful MovementThe 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 | Behavioural | Mindful Movement |
| Keys to Health & WellbeingThis 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. | Other | Keys to Health & Wellbeing |
Primary outcome
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Time frame: Baseline
Minutes/week spent in ≥10-min bouts of MVPA
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
84 secondary outcomes
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Time frame: Change score: 26 weeks - baseline
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts
Time frame: Change score: 52 weeks - baseline
Total Moderate-Vigorous Physical Activity (MVPA)
Time frame: Baseline
Total Moderate-Vigorous Physical Activity (MVPA)
Time frame: Change score: 9 weeks - baseline
Total Moderate-Vigorous Physical Activity (MVPA)
Time frame: Change score: 26 weeks - baseline
Total Moderate-Vigorous Physical Activity (MVPA)
Time frame: Change score: 52 weeks - baseline
Sedentary Activity
Time frame: Baseline
Sedentary Activity
Time frame: Change score: 9 weeks - baseline
Sedentary Activity
Time frame: Change score: 26 weeks - baseline
Sedentary Activity
Time frame: Change score: 52 weeks - baseline
Average Daily Step Count
Time frame: Baseline
Average Daily Step Count
Time frame: Change score: 9 weeks - baseline
Average Daily Step Count
Time frame: Change score: 26 weeks - baseline
Average Daily Step Count
Time frame: Change score: 52 weeks - baseline
Quality of Life - Euroqol 5D (EQ5D)
Time frame: Baseline
Quality of Life - Euroqol 5D (EQ5D)
Time frame: Change score: 9 weeks - baseline
Quality of Life - Euroqol 5D (EQ5D)
Time frame: Change score: 26 weeks - baseline
Quality of Life - Euroqol 5D (EQ5D)
Time frame: Change score: 52 weeks - baseline
Quality of Life - EuroQol VAS
Time frame: Baseline
Quality of Life - EuroQol VAS
Time frame: Change score: 9 weeks - baseline
Quality of Life - EuroQol VAS
Time frame: Change score: 26 weeks - baseline
Quality of Life - EuroQol VAS
Time frame: Change score: 52 weeks - baseline
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
Time frame: Baseline
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
Time frame: Change score: 9 weeks - baseline
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
Time frame: Change score: 26 weeks - baseline
Exercise Self-Efficacy- Self-Efficacy for Exercise (SEE) Scale
Time frame: Change score: 52 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
Time frame: Baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
Time frame: Change score: 9 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
Time frame: Change score: 26 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Positive Sub-scale
Time frame: Change score: 52 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
Time frame: Baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
Time frame: Change score: 9 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
Time frame: Change score: 26 weeks - baseline
Exercise Expectations-Outcome Expectations for Exercise-2 (OEE-2) Negative Sub-scale
Time frame: Change score: 52 weeks - baseline
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Time frame: Baseline
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Time frame: Change score: 9 weeks - baseline
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Time frame: Change score: 26 weeks - baseline
Mindfulness - Mindful Attention Awareness Scale (MAAS)
Time frame: Change score: 52 weeks - baseline
Mindfulness - Frieberg Mindfulness Inventory (FMI)
Time frame: Baseline
Mindfulness - Frieberg Mindfulness Inventory (FMI)
Time frame: Change score: 9 weeks - baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study WebsiteLink provided by the sponsor.
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Recruiting
Promoting Physical Activity and Healthy Eating in Latinas
Physical Inactivty, Physical Activity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Movement and Keys to Health & Wellbeing in people with Physical Inactivty and Wellbeing, run by University of Minnesota at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate-Vigorous Physical Activity (MVPA) in 10 Min Bouts (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.