An interventional study of Yoga Intervention in Sedentary Behavior, sponsored by University of Minnesota. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by University of Minnesota · Not applicable, Interventional, and Prevention
This study aims to test the feasibility, acceptability, safety of a 3-month hatha and restorative yoga intervention to decrease sedentary behavior, stress and blood pressure in sedentary African-American women.
This study aims to assess feasibility of a hatha and restorative yoga intervention compared to a control group. Investigators will examine feasibility of participant recruitment, retention and adherence; fidelity of intervention delivery; and intervention materials. Investigators also aim to evaluate the acceptability and safety of a hatha and restorative yoga intervention compared to a control group. Investigators will examine the acceptability of intervention location and strategies, class format, enjoyment of sessions, and safety of the intervention. Finally, investigators aim to test feasibility and appropriateness of the targeted outcomes for subsequent trials. Expected outcomes will be properly measured, but no comparisons between intervention and control groups will be made.
University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Yoga Intervention
Control participants will receive no guidance from the research staff to change their behavior.
This group will have in-person, 60 minute yoga sessions three times per week for 12 weeks. These sessions will also include a sharing circle to provide group feedback as to how the practice felt and integration into ones' daily life. There will be biweekly themes established for these sessions (i.e. common yoga poses, importance of breath) and biweekly in-person workshops will be offered. These will be specialty classes for participants to experience additional exposure to meditation and breathing. They will be a longer format so participants can delve deeper into yogic philosophy and practice. There will also be a private Facebook group for participants to connect with each other and for the research staff to maintain contact and share information with the participants (eg. weekly reminder for yoga sessions and workshops).
Number of Participants Recruited (Feasibility)
Goals were for 200 women recruited and screened for eligibility, and 60 enrolled and consented.
Time frame: Baseline
Rate of Participant Retention and Adherence (Feasibility)
At least 80% of intervention participants attend at least 80% of intervention sessions
Time frame: During the 12-week yoga intervention
Fidelity of Intervention Delivery (Feasibility)
At least 90% (8 of 9 class segments) of each of the 6 videotaped sessions is delivered as planned based on training.
Time frame: During the 12-week yoga intervention
Rate of Delivery of Intervention Materials and Resources (Feasibility)
100% of intervention materials and resources are delivered as planned to intervention participants.
Time frame: During the 12-week yoga intervention
Rating of Assessment Measures (Feasibility)
At least 80% intervention and control participants rate the assessments as not too burdensome (rated 1 or 2) on a scale from 1 (not burdensome) to 5 (very burdensome).
Time frame: Baseline
Completion of Assessment Measures (Feasibility)
At least 90% intervention and control participants will complete baseline assessments.
Time frame: Baseline
Rating of Assessment Measures (Feasibility)
At least 80% intervention and control participants rate the assessments as not too burdensome (rated 1 or 2) on a scale from 1 (not burdensome) to 5 (very burdensome).
Time frame: Post-intervention (within 2 months)
Completion of Assessment Measures (Feasibility)
At least 90% of intervention and control participants will complete post-intervention assessments.
Time frame: Post-Intervention (within 2 months)
Rating of Assessment Measures (Feasibility)
At least 80% intervention and control participants rate the assessments as not too burdensome (rated 1 or 2) on a scale from 1 (not burdensome) to 5 (very burdensome).
Time frame: 3-month follow-up
Completion of Assessment Measures (Feasibility)
At least 90% of intervention and control participants will complete 3-month follow-up assessments.
Time frame: 3-month follow-up
Rating of Intervention Components (Acceptability)
At least 90% intervention participants rate the various intervention components (e.g., location, in-person classes, instructors, home-based resources) as acceptable with a rating of 4, 5, or 6 on a scale from 1 (strongly dislike) to 6 (strongly like).
Time frame: Post-intervention (within 2 months)
Participant Rating of Yoga Intervention (Acceptability)
At least 90% intervention participants rate intervention acceptable (i.e., rating of 4, 5, or 6 on a scale from 1 (strongly dislike) to 6 (strongly like)) and enjoyable (i.e., rating of 3, 4, or 5 on a scale from 1 (not enjoyed) to 5 (enjoyed very much)).
Time frame: Post-intervention (within 2 months)
Number of Adverse Events (Safety)
Zero adverse events (causes major disruption to participants' life, e.g., sprain, broken bone, cardiovascular event, death), zero moderate adverse events (causes minor inconvenience to participant, e.g., fainting spell, sore muscles for more than 3 days) and less than 10% of participants report mild adverse events (no major impact, e.g., headache, sore muscles for 2-3 days)
Time frame: During the 12-week yoga intervention
Sedentary Behavior
Objective sedentary time (i.e., time spent sitting and lying down) assessed with activPAL4 micro accelerometer. Analyze data to report average total hours of sedentary behavior per day.
Time frame: Seven consecutive days at three time points: baseline before intervention, post-intervention (within 2 months), and 3-month follow-up.
Systolic and Diastolic Blood Pressure
Measured using the automated OMRON Hem 907XL blood pressure recorder. Three blood pressures will be collected and averaged at each data collection time point following a two minute period of rest.
Time frame: Three blood pressures will be collected and averaged at each of the 3 data collection time points (baseline, post-intervention (within 2 months), and 3 month follow-up)
Perceived Stress
Measured using the 14-item Perceived Stress Scale. Each item is scored from 1-5, with higher scores indicating higher perceived stress. Estimates represent the mean total score of the 14 items, ranging from 1-5. Scale was included in an online survey that participants completed at the data collection site via an iPad. Survey items asked participants how often they had experienced acute stress within last month.
Time frame: Surveys will be distributed at each data collection timepoint (baseline, post-intervention (within 2 months), and 3 month follow-up)
Participants were recruited from the greater Twin Cities, MN area via social media, emails to organizations, flyers, websites, and a news segment on a local TV station. The online interest/pre-screening survey received 319 unique responses between March 2022 and May 2022. The first participant consented and enrolled on May 2, 2022.
| Milestone | Yoga Intervention Group | Control Group |
|---|---|---|
| Started | 34 | 34 |
| Post-intervention | 31 | 26 |
| 3-month follow-up | 23 | 28 |
| Completed | 31 | 30 |
| Not completed | 3 | 4 |
| Withdrew: Lost to follow-up | 2 | 4 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Goals were for 200 women recruited and screened for eligibility, and 60 enrolled and consented.
| Participants | Total Recruitment Sample, Pre-Assignment |
|---|---|
| Number of Participants Recruited and Screened | 319 |
| Number of Participants Enrolled and Consented | 69 |
At least 80% of intervention participants attend at least 80% of intervention sessions
| Participants | Yoga Intervention Group |
|---|---|
| Rate of Participant Retention and Adherence (Feasibility) | 8 |
At least 90% (8 of 9 class segments) of each of the 6 videotaped sessions is delivered as planned based on training.
| yoga segments | Yoga Segments |
|---|---|
| Session 1 | 8 |
| Session 2 | 7 |
| Session 3 | 9 |
| Session 4 | 9 |
| Session 5 | 8 |
| Session 6 | 8 |
100% of intervention materials and resources are delivered as planned to intervention participants.
| Participants | Yoga Intervention Group |
|---|---|
| Yoga Equipment | 31 |
| Resource Guide | 33 |
| Pose Book | 33 |
| Facebook Group Invitation | 25 |
| Workshop Pamphlet | 28 |
| Workshop Book | 27 |
At least 80% intervention and control participants rate the assessments as not too burdensome (rated 1 or 2) on a scale from 1 (not burdensome) to 5 (very burdensome).
| Participants | Yoga Intervention Group | Control Group |
|---|---|---|
| Traveling to the clinic to complete measurements | 20 | 15 |
| Getting weight and blood pressure measured by research staff | 21 | 17 |
| Completing electronic survey on an iPad | 23 | 16 |
| Collecting saliva samples for two days | 11 | 8 |
| Wearing the activity monitor for seven days | 19 | 14 |
| Traveling to the clinic to return saliva samples and activity monitor | 18 | 15 |
At least 90% intervention and control participants will complete baseline assessments.
| Participants | Yoga Intervention Group | Control Group |
|---|---|---|
| Survey | 34 | 34 |
| Height, Weight, and Blood Pressure | 34 | 34 |
| ActivPAL Activity Monitor | 32 | 32 |
| Saliva Samples | 32 | 32 |
At least 80% intervention and control participants rate the assessments as not too burdensome (rated 1 or 2) on a scale from 1 (not burdensome) to 5 (very burdensome).
| Participants | Yoga Intervention Group | Control Group |
|---|---|---|
| Traveling to the clinic to complete measurements | 27 | 19 |
| Getting weight and blood pressure measured by research staff | 30 | 22 |
| Completing electronic survey on an iPad | 25 | 20 |
| Collecting saliva samples for two days | 2 | 0 |
| Wearing the activity monitor for seven days | 3 | 1 |
| Traveling to the clinic to return saliva samples and activity monitor | 3 | 1 |
At least 90% of intervention and control participants will complete post-intervention assessments.
| Participants | Yoga Intervention Group | Control Group |
|---|---|---|
| Survey | 31 | 26 |
| Weight and Blood Pressure | 31 | 26 |
| ActivPAL Activity Monitor | 27 | 23 |
| Saliva Samples | 27 | 24 |
At least 80% intervention and control participants rate the assessments as not too burdensome (rated 1 or 2) on a scale from 1 (not burdensome) to 5 (very burdensome).
| Participants | Yoga Intervention Group | Control Group |
|---|---|---|
| Traveling to the clinic to complete measurements | 17 | 17 |
| Getting weight and blood pressure measured by research staff | 20 | 27 |
| Completing electronic survey on an iPad | 17 | 21 |
| Collecting saliva samples for two days | 15 | 13 |
| Wearing the activity monitor for seven days | 14 | 22 |
| Traveling to the clinic to return saliva samples and activity monitor | 16 | 15 |
At least 90% of intervention and control participants will complete 3-month follow-up assessments.
| Participants | Yoga Intervention Group | Control Group |
|---|---|---|
| Survey | 23 | 28 |
| Weight and Blood Pressure | 23 | 28 |
| ActivPAL Activity Monitor | 22 | 28 |
| Saliva Samples | 20 | 27 |
At least 90% intervention participants rate the various intervention components (e.g., location, in-person classes, instructors, home-based resources) as acceptable with a rating of 4, 5, or 6 on a scale from 1 (strongly dislike) to 6 (strongly like).
| Participants | Yoga Intervention Group |
|---|---|
| Intervention location | 26 |
| Instructors | 31 |
| Yoga poses and sequencing (i.e., level of difficulty and modifications) | 29 |
| Yoga instruction (including music and use of Sanskrit/English terms) | 30 |
| Yoga equipment (i.e., mats, blocks, bolster, strap, blanket) | 31 |
| Availability of different class formats (i.e., in person, Zoom, recordings) | 29 |
| Class frequency of 3 times per week | 30 |
| Class time of day | 23 |
| Duration of the class (60 minutes) | 29 |
| Sharing circle at the end of each yoga class | 27 |
| Time of year of intervention (during the summer) | 23 |
| Biweekly workshops | 27 |
| Workshop resources (book and pamphlet) | 31 |
| Pose book | 31 |
| Private Facebook group and posts | 25 |
At least 90% intervention participants rate intervention acceptable (i.e., rating of 4, 5, or 6 on a scale from 1 (strongly dislike) to 6 (strongly like)) and enjoyable (i.e., rating of 3, 4, or 5 on a scale from 1 (not enjoyed) to 5 (enjoyed very much)).
| Participants | Yoga Intervention Group |
|---|---|
| Overall acceptability of yoga program | 30 |
| Enjoyment of program | 31 |
Zero adverse events (causes major disruption to participants' life, e.g., sprain, broken bone, cardiovascular event, death), zero moderate adverse events (causes minor inconvenience to participant, e.g., fainting spell, sore muscles for more than 3 days) and less than 10% of participants report mild adverse events (no major impact, e.g., headache, sore muscles for 2-3 days)
| Participants | Yoga Intervention Group |
|---|---|
| Adverse event (causes major disruption to participants' life) | 0 |
| Moderate adverse events (causes minor inconvenience to participant) | 0 |
| Mild adverse events (no major impact) | 1 |
Objective sedentary time (i.e., time spent sitting and lying down) assessed with activPAL4 micro accelerometer. Analyze data to report average total hours of sedentary behavior per day.
| hours of sedentary behavior per day | Yoga Intervention Group | Control Group |
|---|---|---|
| Baseline | 10.7 ± 1.7 | 10.2 ± 2.0 |
| Post-Intervention | 11.4 ± 1.9 | 10.3 ± 1.8 |
| 3-Month Follow-Up | 10.8 ± 1.8 | 10.2 ± 2.4 |
Measured using the automated OMRON Hem 907XL blood pressure recorder. Three blood pressures will be collected and averaged at each data collection time point following a two minute period of rest.
| mmHg | Yoga Intervention Group | Control Group |
|---|---|---|
| Baseline: Systolic Blood Pressure | 114.2 ± 13.6 | 116.1 ± 14.0 |
| Baseline: Diastolic Blood Pressure | 77.2 ± 11.5 | 77.2 ± 12.7 |
| Post-Intervention: Systolic Blood Pressure | 118.0 ± 18.4 | 115.9 ± 15.5 |
| Post-Intervention: Diastolic Blood Pressure | 77.2 ± 11.7 | 75.6 ± 12.3 |
| 3-Month Follow-Up: Systolic Blood Pressure | 118.6 ± 16.1 | 119.6 ± 18.4 |
| 3-Month Follow-Up: Diastolic Blood Pressure | 78.0 ± 12.4 | 78.0 ± 15.5 |
Measured using the 14-item Perceived Stress Scale. Each item is scored from 1-5, with higher scores indicating higher perceived stress. Estimates represent the mean total score of the 14 items, ranging from 1-5. Scale was included in an online survey that participants completed at the data collection site via an iPad. Survey items asked participants how often they had experienced acute stress within last month.
| score on a scale | Yoga Intervention Group | Control Group |
|---|---|---|
| Baseline | 2.9 ± 0.4 | 2.8 ± 0.5 |
| Post-Intervention | 2.6 ± 0.4 | 2.6 ± 0.5 |
| Follow-Up | 2.7 ± 0.5 | 2.7 ± 0.6 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Yoga Intervention Group | 0/33 (0%) | 0/33 (0%) | 1/33 (3%) |
| Event | Yoga Intervention Group |
|---|---|
| Mild Adverse EventMusculoskeletal and connective tissue disorders | 1/33 |
| Age, Continuous(years) | Yoga Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 44.6 ± 9.4 | 43.4 ± 11.2 | 44.0 ± 10.4 |
| Sex: Female, Male(Participants) | Yoga Intervention Group | Control Group | Total |
|---|---|---|---|
| Female | 34 | 34 | 68 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Yoga Intervention Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 34 | 34 | 68 |
| Race (NIH/OMB)(Participants) | Yoga Intervention Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 34 | 34 | 68 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Yoga Intervention Group | Control Group | Total |
|---|---|---|---|
| United States | 34 | 34 | 68 |
| Education(Participants) | Yoga Intervention Group | Control Group | Total |
|---|---|---|---|
| Completed high school or GED | 2 | 0 | 2 |
| Some college or technical school | 6 | 8 | 14 |
| Completed associate's degree or technical school | 3 | 4 | 7 |
| Completed bachelor's degree | 8 | 7 | 15 |
| Attends or has attended graduate school | 3 | 3 | 6 |
| Completed graduate school | 12 | 12 | 24 |
| Employment(Participants) | Yoga Intervention Group | Control Group | Total |
|---|---|---|---|
| Employed | 30 | 31 | 61 |
| Not currently employed | 2 | 1 | 3 |
| Student | 2 | 2 | 4 |
| Income(Participants) | Yoga Intervention Group | Control Group | Total |
|---|---|---|---|
| <$35,000 | 3 | 5 | 8 |
| $35,000 - $49,999 | 5 | 6 | 11 |
| $50,000 - $74,999 | 12 | 9 | 21 |
| $75,000 - $99,999 | 2 | 4 | 6 |
| >$100,000 | 10 | 9 | 19 |
| Prefer not to answer | 2 | 1 | 3 |
4 further baseline measures are reported on the registry.
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