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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT011036 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga Intervention Group | Experimental |
| |
| Control Group | No Intervention | Control participants will receive no guidance from the research staff to change their behavior. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga Intervention | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Recruited (Feasibility) | Goals were for 200 women recruited and screened for eligibility, and 60 enrolled and consented. | Baseline |
| Rate of Participant Retention and Adherence (Feasibility) | At least 80% of intervention participants attend at least 80% of intervention sessions | 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. | 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. | 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). | Baseline |
| Completion of Assessment Measures (Feasibility) | At least 90% intervention and control participants will complete baseline assessments. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Seven consecutive days at three time points: baseline before intervention, post-intervention (within 2 months), and 3-month follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daheia J Barr-Anderson, PhD, MSPH | University of Minnesota | Principal Investigator |
| Mark A Pereira, PhD, MPH | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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Of the 131 individuals who were assessed for eligibility after pre-screening, 69 met the inclusion criteria and consented. Prior to randomization, 1 participant voluntarily withdrew from the study due to discomfort providing salivary samples. Of the 68 participants randomized to intervention groups, 1 participant involuntarily withdrew prior to the start of the intervention due to injuries sustained in an accident unrelated to the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Yoga Intervention Group | Yoga Intervention: 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). |
| FG001 | Control Group | Control participants will receive no guidance from the research staff to change their behavior. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Yoga Intervention Group | Yoga Intervention: 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Recruited (Feasibility) | Goals were for 200 women recruited and screened for eligibility, and 60 enrolled and consented. | Total number of participants who were recruited and screened via an online interest/pre-screening survey. For this outcome measure analysis, we will report the number of recruited participants who then enrolled and consented in the study. This pre-assignment sample size differs from the number of participants who started the 12-week intervention period because 2 participants withdrew from the study before the 12-week intervention period began. | Posted | Count of Participants | Participants | Baseline |
|
12 weeks
Intervention group participants were instructed to call their healthcare provider and notify the research staff if they experienced an injury or any adverse event. Participants in the Control Group were not assessed for deaths or adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Yoga Intervention Group | Yoga Intervention: 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Adverse Event | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Knee pain experienced during a yoga session. |
Although Specific Aim 4 addressing the feasibility of salivary sample collection was achieved, due to budgetary constraints, the research team was unable to analyze the cortisol levels of the saliva samples.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daheia J. Barr-Anderson | University of Minnesota | 240-475-2806 | barra027@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2022 | Jul 5, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2022 | Jul 5, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| Post-intervention (within 2 months) |
| Completion of Assessment Measures (Feasibility) | At least 90% of intervention and control participants will complete post-intervention assessments. | 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). | 3-month follow-up |
| Completion of Assessment Measures (Feasibility) | At least 90% of intervention and control participants will complete 3-month follow-up assessments. | 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). | 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)). | 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) | During the 12-week yoga intervention |
| 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. |
| 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. | Surveys will be distributed at each data collection timepoint (baseline, post-intervention (within 2 months), and 3 month follow-up) |
| BG001 | Control Group | Control participants will receive no guidance from the research staff to change their behavior. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education | Highest level of education completed. | Count of Participants | Participants |
|
| Employment | Current occupation status. | Count of Participants | Participants |
|
| Income | Total household income before taxes in the past year. | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Sedentary Behavior | Average total number of hours per day engaged in sedentary behavior, assessed via participants wearing the activPAL4 micro accelerometer for 7 consecutive days. | Activity monitor data missing from four participants who did not return their activity monitors. | Mean | Standard Deviation | Hours per day |
|
| Systolic and Diastolic Blood Pressure | Average of three blood pressure readings measured using the OMRON Hem 907XL blood pressure monitor. | Unable to obtain blood pressure readings from one intervention participant due to equipment malfunction. | Mean | Standard Deviation | mmHg |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Rate of Participant Retention and Adherence (Feasibility) | At least 80% of intervention participants attend at least 80% of intervention sessions | The number of participants analyzed was 33 because this outcome was measured during the 12-week yoga intervention and prior to the post-intervention data collection milestone. There were originally 34 participants randomized to the yoga intervention, but 1 intervention participant officially withdrew from the study prior to the start of the intervention. Thus, we calculated attendance rates for 33 intervention participants. | Posted | Count of Participants | Participants | During the 12-week yoga intervention |
|
|
|
| Primary | 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. | Please note that no participants were analyzed for this outcome measure. Six video recordings of yoga intervention sessions were analyzed to enumerate the number of yoga segments (e.g., planned specific yoga components) that were completed as a percentage of the total (n = 9 yoga segments per session). | Posted | Count of Units | yoga segments | During the 12-week yoga intervention | yoga segments | yoga segments |
|
|
|
| Primary | Rate of Delivery of Intervention Materials and Resources (Feasibility) | 100% of intervention materials and resources are delivered as planned to intervention participants. | Compute the percentage of intervention participants who receive the materials and resources throughout the intervention. The number of participants analyzed was 33 because this outcome was measured during the 12-week yoga intervention and prior to the post-intervention data collection milestone. There were originally 34 participants randomized to the yoga intervention, but 1 intervention participant officially withdrew from the study prior to the start of the intervention. | Posted | Count of Participants | Participants | During the 12-week yoga intervention |
|
|
|
| Primary | 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). | These survey items were sent via email to participants after baseline assessments were completed and prior to randomization. A total of 44 participants (25 intervention participants and 19 control group participants) completed the survey. Thus, the total sample size for this outcome measure is 44. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Completion of Assessment Measures (Feasibility) | At least 90% intervention and control participants will complete baseline assessments. | Total sample of participants who enrolled, consented, and were randomized into the intervention and control groups. Excludes participant who withdrew from the study prior to randomization (n = 1). | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | 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). | At post-intervention, 57 participants completed a survey during in-person data collection that included 3 items rating burden of 1) traveling to the clinic, 2) getting weight and blood pressure measured, and 3) completing survey. The remaining 3 items rating burden of 1) collecting saliva samples, 2) wearing activity monitor, and 3) returning equipment were sent via email to participants after they returned their equipment. Only 6 participants responded to the 3 survey items from the email. | Posted | Count of Participants | Participants | Post-intervention (within 2 months) |
|
|
|
| Primary | Completion of Assessment Measures (Feasibility) | At least 90% of intervention and control participants will complete post-intervention assessments. | Excludes 1 intervention group participant who withdrew from the study after randomization but prior to start of the intervention. | Posted | Count of Participants | Participants | Post-Intervention (within 2 months) |
|
|
|
| Primary | 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). | The total sample of participants (n = 51) who completed the survey during their 3-month follow-up data collection visit. The sample size for 2 of the survey items is n = 50 due to missing responses (i.e., the participant completed the rest of the survey but did not submit a response to that item). | Posted | Count of Participants | Participants | 3-month follow-up |
|
|
|
| Primary | Completion of Assessment Measures (Feasibility) | At least 90% of intervention and control participants will complete 3-month follow-up assessments. | Excludes 1 intervention group participant who withdrew from the study after randomization but prior to start of the intervention. | Posted | Count of Participants | Participants | 3-month follow-up |
|
|
|
| Primary | 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). | Of the 33 participants who were randomized to the yoga intervention group, 2 participants were lost to follow-up and did not complete the post-intervention survey that included items rating the acceptability of the intervention components. Thus, the sample size for this outcome measure is n = 31. | Posted | Count of Participants | Participants | Post-intervention (within 2 months) |
|
|
|
| Primary | 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)). | Of the 33 participants who were randomized to the yoga intervention group, 2 participants were lost to follow-up and did not complete the post-intervention survey that included items rating the acceptability of the intervention. Thus, the sample size for this outcome measure is n = 31. | Posted | Count of Participants | Participants | Post-intervention (within 2 months) |
|
|
|
| Primary | 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) | Of the 33 participants who were randomized to the yoga intervention group, 2 participants were lost to follow-up and did not attend any of the yoga sessions. Thus, the sample size for this outcome measure is n = 31. We did not assess Adverse Events within the control group during the course of the 12-week yoga intervention, as we did not have contact with the control group during this time frame. | Posted | Count of Participants | Participants | During the 12-week yoga intervention |
|
|
|
| Secondary | 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. | At each time point, results will be reported for participants who returned activPAL4 micro accelerometers with monitor wear data. At baseline, 32 yoga intervention group participants and 32 control group participants returned activPAL4 micro accelerometers with monitor wear data. | Posted | Mean | Standard Deviation | hours of sedentary behavior per day | Seven consecutive days at three time points: baseline before intervention, post-intervention (within 2 months), and 3-month follow-up. |
|
|
|
| Secondary | 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. | Blood pressure measures are missing from participants who did not complete in-person data collection visits at the post-intervention and 3-month follow-up time points, and from one intervention group participant who was unable to provide accurate blood pressure readings at both baseline and 3-month follow-up due to equipment malfunction. | Posted | Mean | Standard Deviation | mmHg | 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) |
|
|
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| Secondary | 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. | All participants who completed Perceived Stress Scale as part of the survey that was distributed at the in-person data collection time points. | Posted | Mean | Standard Deviation | score on a scale | Surveys will be distributed at each data collection timepoint (baseline, post-intervention (within 2 months), and 3 month follow-up) |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 1 |
| 33 |
|
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
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| Unknown or Not Reported |
|
| Completed associate's degree or technical school |
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| Completed bachelor's degree |
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| Attends or has attended graduate school |
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| Completed graduate school |
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| Student |
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| $50,000 - $74,999 |
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| $75,000 - $99,999 |
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| >$100,000 |
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| Prefer not to answer |
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| Separated/Divorced/Widowed |
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| Single, never married |
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| Title | Measurements |
|---|
|
| Session 4 |
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| Session 5 |
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| Session 6 |
|
| Title | Measurements |
|---|---|
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| Facebook Group Invitation |
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| Workshop Pamphlet |
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| Workshop Book |
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| Completing electronic survey on an iPad |
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| Collecting saliva samples for two days |
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| Wearing the activity monitor for seven days |
|
| Traveling to the clinic to return saliva samples and activity monitor |
|
| ActivPAL Activity Monitor |
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| Saliva Samples |
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| Getting weight and blood pressure measured by research staff |
|
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| Completing electronic survey on an iPad |
|
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| Collecting saliva samples for two days |
|
|
| Wearing the activity monitor for seven days |
|
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| Traveling to the clinic to return saliva samples and activity monitor |
|
|
| ActivPAL Activity Monitor |
|
| Saliva Samples |
|
| Getting weight and blood pressure measured by research staff |
|
|
| Completing electronic survey on an iPad |
|
|
| Collecting saliva samples for two days |
|
|
| Wearing the activity monitor for seven days |
|
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| Traveling to the clinic to return saliva samples and activity monitor |
|
|
| ActivPAL Activity Monitor |
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| Saliva Samples |
|
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| Yoga poses and sequencing (i.e., level of difficulty and modifications) |
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| Yoga instruction (including music and use of Sanskrit/English terms) |
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| Yoga equipment (i.e., mats, blocks, bolster, strap, blanket) |
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| Availability of different class formats (i.e., in person, Zoom, recordings) |
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| Class frequency of 3 times per week |
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| Class time of day |
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| Duration of the class (60 minutes) |
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| Sharing circle at the end of each yoga class |
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| Time of year of intervention (during the summer) |
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| Biweekly workshops |
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| Workshop resources (book and pamphlet) |
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| Pose book |
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| Private Facebook group and posts |
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| Post-Intervention |
|
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| 3-Month Follow-Up |
|
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| Baseline: Diastolic Blood Pressure |
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| Post-Intervention: Systolic Blood Pressure |
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| Post-Intervention: Diastolic Blood Pressure |
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| 3-Month Follow-Up: Systolic Blood Pressure |
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| 3-Month Follow-Up: Diastolic Blood Pressure |
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| Post-Intervention |
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| Follow-Up |
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