Trial Outcomes & Findings for Feasibility of a Yoga Intervention in Sedentary African-American Women (NCT NCT04710979)

NCT ID: NCT04710979

Last Updated: 2023-10-26

Results Overview

Goals were for 200 women recruited and screened for eligibility, and 60 enrolled and consented.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 69 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2023-10-26

Participant Flow

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.

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.

Participant milestones

Measure	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).	Control Group Control participants will receive no guidance from the research staff to change their behavior.
Overall Study STARTED	34	34
Overall Study Post-Intervention	31	26
Overall Study 3-Month Follow-Up	23	28
Overall Study COMPLETED	31	30
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	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).	Control Group Control participants will receive no guidance from the research staff to change their behavior.
Overall Study Lost to Follow-up	2	4
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Activity monitor data missing from four participants who did not return their activity monitors.

Baseline characteristics by cohort

Measure	Yoga Intervention Group n=34 Participants 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).	Control Group n=34 Participants Control participants will receive no guidance from the research staff to change their behavior.	Total n=68 Participants Total of all reporting groups
Age, Continuous	44.6 years STANDARD_DEVIATION 9.4 • n=34 Participants	43.4 years STANDARD_DEVIATION 11.2 • n=34 Participants	44.0 years STANDARD_DEVIATION 10.4 • n=68 Participants
Sex: Female, Male Female	34 Participants n=34 Participants	34 Participants n=34 Participants	68 Participants n=68 Participants
Sex: Female, Male Male	0 Participants n=34 Participants	0 Participants n=34 Participants	0 Participants n=68 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=34 Participants	0 Participants n=34 Participants	0 Participants n=68 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=34 Participants	0 Participants n=34 Participants	0 Participants n=68 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	34 Participants n=34 Participants	34 Participants n=34 Participants	68 Participants n=68 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=34 Participants	0 Participants n=34 Participants	0 Participants n=68 Participants
Race (NIH/OMB) Asian	0 Participants n=34 Participants	0 Participants n=34 Participants	0 Participants n=68 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=34 Participants	0 Participants n=34 Participants	0 Participants n=68 Participants
Race (NIH/OMB) Black or African American	34 Participants n=34 Participants	34 Participants n=34 Participants	68 Participants n=68 Participants
Race (NIH/OMB) White	0 Participants n=34 Participants	0 Participants n=34 Participants	0 Participants n=68 Participants
Race (NIH/OMB) More than one race	0 Participants n=34 Participants	0 Participants n=34 Participants	0 Participants n=68 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=34 Participants	0 Participants n=34 Participants	0 Participants n=68 Participants
Region of Enrollment United States	34 Participants n=34 Participants	34 Participants n=34 Participants	68 Participants n=68 Participants
Education Completed high school or GED	2 Participants n=34 Participants	0 Participants n=34 Participants	2 Participants n=68 Participants
Education Some college or technical school	6 Participants n=34 Participants	8 Participants n=34 Participants	14 Participants n=68 Participants
Education Completed associate's degree or technical school	3 Participants n=34 Participants	4 Participants n=34 Participants	7 Participants n=68 Participants
Education Completed bachelor's degree	8 Participants n=34 Participants	7 Participants n=34 Participants	15 Participants n=68 Participants
Education Attends or has attended graduate school	3 Participants n=34 Participants	3 Participants n=34 Participants	6 Participants n=68 Participants
Education Completed graduate school	12 Participants n=34 Participants	12 Participants n=34 Participants	24 Participants n=68 Participants
Employment Employed	30 Participants n=34 Participants	31 Participants n=34 Participants	61 Participants n=68 Participants
Employment Not currently employed	2 Participants n=34 Participants	1 Participants n=34 Participants	3 Participants n=68 Participants
Employment Student	2 Participants n=34 Participants	2 Participants n=34 Participants	4 Participants n=68 Participants
Income <$35,000	3 Participants n=34 Participants	5 Participants n=34 Participants	8 Participants n=68 Participants
Income $35,000 - $49,999	5 Participants n=34 Participants	6 Participants n=34 Participants	11 Participants n=68 Participants
Income $50,000 - $74,999	12 Participants n=34 Participants	9 Participants n=34 Participants	21 Participants n=68 Participants
Income $75,000 - $99,999	2 Participants n=34 Participants	4 Participants n=34 Participants	6 Participants n=68 Participants
Income >$100,000	10 Participants n=34 Participants	9 Participants n=34 Participants	19 Participants n=68 Participants
Income Prefer not to answer	2 Participants n=34 Participants	1 Participants n=34 Participants	3 Participants n=68 Participants
Marital Status Married	13 Participants n=34 Participants	8 Participants n=34 Participants	21 Participants n=68 Participants
Marital Status Not married, living with partner	3 Participants n=34 Participants	3 Participants n=34 Participants	6 Participants n=68 Participants
Marital Status Separated/Divorced/Widowed	8 Participants n=34 Participants	7 Participants n=34 Participants	15 Participants n=68 Participants
Marital Status Single, never married	10 Participants n=34 Participants	16 Participants n=34 Participants	26 Participants n=68 Participants
Sedentary Behavior	10.7 Hours per day STANDARD_DEVIATION 1.7 • n=32 Participants • Activity monitor data missing from four participants who did not return their activity monitors.	10.2 Hours per day STANDARD_DEVIATION 2.0 • n=32 Participants • Activity monitor data missing from four participants who did not return their activity monitors.	10.5 Hours per day STANDARD_DEVIATION 1.8 • n=64 Participants • Activity monitor data missing from four participants who did not return their activity monitors.
Systolic and Diastolic Blood Pressure SBP	114.2 mmHg STANDARD_DEVIATION 13.6 • n=33 Participants • Unable to obtain blood pressure readings from one intervention participant due to equipment malfunction.	116.1 mmHg STANDARD_DEVIATION 14.0 • n=34 Participants • Unable to obtain blood pressure readings from one intervention participant due to equipment malfunction.	115.2 mmHg STANDARD_DEVIATION 13.8 • n=67 Participants • Unable to obtain blood pressure readings from one intervention participant due to equipment malfunction.
Systolic and Diastolic Blood Pressure DBP	77.2 mmHg STANDARD_DEVIATION 11.5 • n=33 Participants • Unable to obtain blood pressure readings from one intervention participant due to equipment malfunction.	77.2 mmHg STANDARD_DEVIATION 12.7 • n=34 Participants • Unable to obtain blood pressure readings from one intervention participant due to equipment malfunction.	77.2 mmHg STANDARD_DEVIATION 12.1 • n=67 Participants • Unable to obtain blood pressure readings from one intervention participant due to equipment malfunction.
Perceived Stress	2.9 units on a scale STANDARD_DEVIATION 0.4 • n=34 Participants	2.8 units on a scale STANDARD_DEVIATION 0.5 • n=34 Participants	2.8 units on a scale STANDARD_DEVIATION 0.4 • n=68 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 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.

Goals were for 200 women recruited and screened for eligibility, and 60 enrolled and consented.

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=319 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group Control participants will receive no guidance from the research staff to change their behavior.
Number of Participants Recruited (Feasibility) Number of Participants Recruited and Screened	319 Participants	—
Number of Participants Recruited (Feasibility) Number of Participants Enrolled and Consented	69 Participants	—

PRIMARY outcome

Timeframe: During the 12-week yoga intervention

Population: 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.

At least 80% of intervention participants attend at least 80% of intervention sessions

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=33 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group Control participants will receive no guidance from the research staff to change their behavior.
Rate of Participant Retention and Adherence (Feasibility)	8 Participants	—

PRIMARY outcome

Timeframe: During the 12-week yoga intervention

Population: 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).

At least 90% (8 of 9 class segments) of each of the 6 videotaped sessions is delivered as planned based on training.

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=9 yoga segments All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group Control participants will receive no guidance from the research staff to change their behavior.
Fidelity of Intervention Delivery (Feasibility) Session 1	8 yoga segments	—
Fidelity of Intervention Delivery (Feasibility) Session 2	7 yoga segments	—
Fidelity of Intervention Delivery (Feasibility) Session 3	9 yoga segments	—
Fidelity of Intervention Delivery (Feasibility) Session 6	8 yoga segments	—
Fidelity of Intervention Delivery (Feasibility) Session 4	9 yoga segments	—
Fidelity of Intervention Delivery (Feasibility) Session 5	8 yoga segments	—

PRIMARY outcome

Timeframe: During the 12-week yoga intervention

Population: 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.

100% of intervention materials and resources are delivered as planned to intervention participants.

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=33 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group Control participants will receive no guidance from the research staff to change their behavior.
Rate of Delivery of Intervention Materials and Resources (Feasibility) Yoga Equipment	31 Participants	—
Rate of Delivery of Intervention Materials and Resources (Feasibility) Resource Guide	33 Participants	—
Rate of Delivery of Intervention Materials and Resources (Feasibility) Pose Book	33 Participants	—
Rate of Delivery of Intervention Materials and Resources (Feasibility) Facebook Group Invitation	25 Participants	—
Rate of Delivery of Intervention Materials and Resources (Feasibility) Workshop Pamphlet	28 Participants	—
Rate of Delivery of Intervention Materials and Resources (Feasibility) Workshop Book	27 Participants	—

PRIMARY outcome

Timeframe: Baseline

Population: 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.

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).

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=25 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group n=19 Participants Control participants will receive no guidance from the research staff to change their behavior.
Rating of Assessment Measures (Feasibility) Traveling to the clinic to complete measurements	20 Participants	15 Participants
Rating of Assessment Measures (Feasibility) Getting weight and blood pressure measured by research staff	21 Participants	17 Participants
Rating of Assessment Measures (Feasibility) Completing electronic survey on an iPad	23 Participants	16 Participants
Rating of Assessment Measures (Feasibility) Collecting saliva samples for two days	11 Participants	8 Participants
Rating of Assessment Measures (Feasibility) Wearing the activity monitor for seven days	19 Participants	14 Participants
Rating of Assessment Measures (Feasibility) Traveling to the clinic to return saliva samples and activity monitor	18 Participants	15 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 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).

At least 90% intervention and control participants will complete baseline assessments.

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=34 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group n=34 Participants Control participants will receive no guidance from the research staff to change their behavior.
Completion of Assessment Measures (Feasibility) Survey	34 Participants	34 Participants
Completion of Assessment Measures (Feasibility) Height, Weight, and Blood Pressure	34 Participants	34 Participants
Completion of Assessment Measures (Feasibility) ActivPAL Activity Monitor	32 Participants	32 Participants
Completion of Assessment Measures (Feasibility) Saliva Samples	32 Participants	32 Participants

PRIMARY outcome

Timeframe: Post-intervention (within 2 months)

Population: 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.

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).

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=31 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group n=26 Participants Control participants will receive no guidance from the research staff to change their behavior.
Rating of Assessment Measures (Feasibility) Traveling to the clinic to complete measurements	27 Participants	19 Participants
Rating of Assessment Measures (Feasibility) Getting weight and blood pressure measured by research staff	30 Participants	22 Participants
Rating of Assessment Measures (Feasibility) Completing electronic survey on an iPad	25 Participants	20 Participants
Rating of Assessment Measures (Feasibility) Collecting saliva samples for two days	2 Participants	0 Participants
Rating of Assessment Measures (Feasibility) Wearing the activity monitor for seven days	3 Participants	1 Participants
Rating of Assessment Measures (Feasibility) Traveling to the clinic to return saliva samples and activity monitor	3 Participants	1 Participants

PRIMARY outcome

Timeframe: Post-Intervention (within 2 months)

Population: Excludes 1 intervention group participant who withdrew from the study after randomization but prior to start of the intervention.

At least 90% of intervention and control participants will complete post-intervention assessments.

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=33 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group n=34 Participants Control participants will receive no guidance from the research staff to change their behavior.
Completion of Assessment Measures (Feasibility) Saliva Samples	27 Participants	24 Participants
Completion of Assessment Measures (Feasibility) Survey	31 Participants	26 Participants
Completion of Assessment Measures (Feasibility) Weight and Blood Pressure	31 Participants	26 Participants
Completion of Assessment Measures (Feasibility) ActivPAL Activity Monitor	27 Participants	23 Participants

PRIMARY outcome

Timeframe: 3-month follow-up

Population: 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).

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).

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=23 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group n=28 Participants Control participants will receive no guidance from the research staff to change their behavior.
Rating of Assessment Measures (Feasibility) Traveling to the clinic to complete measurements	17 Participants	17 Participants
Rating of Assessment Measures (Feasibility) Getting weight and blood pressure measured by research staff	20 Participants	27 Participants
Rating of Assessment Measures (Feasibility) Completing electronic survey on an iPad	17 Participants	21 Participants
Rating of Assessment Measures (Feasibility) Collecting saliva samples for two days	15 Participants	13 Participants
Rating of Assessment Measures (Feasibility) Wearing the activity monitor for seven days	14 Participants	22 Participants
Rating of Assessment Measures (Feasibility) Traveling to the clinic to return saliva samples and activity monitor	16 Participants	15 Participants

PRIMARY outcome

Timeframe: 3-month follow-up

Population: Excludes 1 intervention group participant who withdrew from the study after randomization but prior to start of the intervention.

At least 90% of intervention and control participants will complete 3-month follow-up assessments.

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=33 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group n=34 Participants Control participants will receive no guidance from the research staff to change their behavior.
Completion of Assessment Measures (Feasibility) Survey	23 Participants	28 Participants
Completion of Assessment Measures (Feasibility) Weight and Blood Pressure	23 Participants	28 Participants
Completion of Assessment Measures (Feasibility) ActivPAL Activity Monitor	22 Participants	28 Participants
Completion of Assessment Measures (Feasibility) Saliva Samples	20 Participants	27 Participants

PRIMARY outcome

Timeframe: Post-intervention (within 2 months)

Population: 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.

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).

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=31 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group Control participants will receive no guidance from the research staff to change their behavior.
Rating of Intervention Components (Acceptability) Intervention location	26 Participants	—
Rating of Intervention Components (Acceptability) Instructors	31 Participants	—
Rating of Intervention Components (Acceptability) Yoga poses and sequencing (i.e., level of difficulty and modifications)	29 Participants	—
Rating of Intervention Components (Acceptability) Yoga instruction (including music and use of Sanskrit/English terms)	30 Participants	—
Rating of Intervention Components (Acceptability) Yoga equipment (i.e., mats, blocks, bolster, strap, blanket)	31 Participants	—
Rating of Intervention Components (Acceptability) Availability of different class formats (i.e., in person, Zoom, recordings)	29 Participants	—
Rating of Intervention Components (Acceptability) Class frequency of 3 times per week	30 Participants	—
Rating of Intervention Components (Acceptability) Class time of day	23 Participants	—
Rating of Intervention Components (Acceptability) Duration of the class (60 minutes)	29 Participants	—
Rating of Intervention Components (Acceptability) Sharing circle at the end of each yoga class	27 Participants	—
Rating of Intervention Components (Acceptability) Time of year of intervention (during the summer)	23 Participants	—
Rating of Intervention Components (Acceptability) Biweekly workshops	27 Participants	—
Rating of Intervention Components (Acceptability) Workshop resources (book and pamphlet)	31 Participants	—
Rating of Intervention Components (Acceptability) Pose book	31 Participants	—
Rating of Intervention Components (Acceptability) Private Facebook group and posts	25 Participants	—

PRIMARY outcome

Timeframe: Post-intervention (within 2 months)

Population: 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.

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)).

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=31 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group Control participants will receive no guidance from the research staff to change their behavior.
Participant Rating of Yoga Intervention (Acceptability) Overall acceptability of yoga program	30 Participants	—
Participant Rating of Yoga Intervention (Acceptability) Enjoyment of program	31 Participants	—

PRIMARY outcome

Timeframe: During the 12-week yoga intervention

Population: 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.

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)

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=31 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group Control participants will receive no guidance from the research staff to change their behavior.
Number of Adverse Events (Safety) Adverse event (causes major disruption to participants' life)	0 Participants	—
Number of Adverse Events (Safety) Moderate adverse events (causes minor inconvenience to participant)	0 Participants	—
Number of Adverse Events (Safety) Mild adverse events (no major impact)	1 Participants	—

SECONDARY outcome

Timeframe: Seven consecutive days at three time points: baseline before intervention, post-intervention (within 2 months), and 3-month follow-up.

Population: 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.

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.

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=32 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group n=32 Participants Control participants will receive no guidance from the research staff to change their behavior.
Sedentary Behavior Baseline	10.7 hours of sedentary behavior per day Standard Deviation 1.7	10.2 hours of sedentary behavior per day Standard Deviation 2.0
Sedentary Behavior Post-Intervention	11.4 hours of sedentary behavior per day Standard Deviation 1.9	10.3 hours of sedentary behavior per day Standard Deviation 1.8
Sedentary Behavior 3-Month Follow-Up	10.8 hours of sedentary behavior per day Standard Deviation 1.8	10.2 hours of sedentary behavior per day Standard Deviation 2.4

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=34 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group n=34 Participants Control participants will receive no guidance from the research staff to change their behavior.
Systolic and Diastolic Blood Pressure Post-Intervention: Diastolic Blood Pressure	77.2 mmHg Standard Deviation 11.7	75.6 mmHg Standard Deviation 12.3
Systolic and Diastolic Blood Pressure Baseline: Systolic Blood Pressure	114.2 mmHg Standard Deviation 13.6	116.1 mmHg Standard Deviation 14.0
Systolic and Diastolic Blood Pressure Baseline: Diastolic Blood Pressure	77.2 mmHg Standard Deviation 11.5	77.2 mmHg Standard Deviation 12.7
Systolic and Diastolic Blood Pressure Post-Intervention: Systolic Blood Pressure	118.0 mmHg Standard Deviation 18.4	115.9 mmHg Standard Deviation 15.5
Systolic and Diastolic Blood Pressure 3-Month Follow-Up: Systolic Blood Pressure	118.6 mmHg Standard Deviation 16.1	119.6 mmHg Standard Deviation 18.4
Systolic and Diastolic Blood Pressure 3-Month Follow-Up: Diastolic Blood Pressure	78.0 mmHg Standard Deviation 12.4	78.0 mmHg Standard Deviation 15.5

SECONDARY outcome

Timeframe: Surveys will be distributed at each data collection timepoint (baseline, post-intervention (within 2 months), and 3 month follow-up)

Population: All participants who completed Perceived Stress Scale as part of the survey that was distributed at the in-person data collection time points.

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.

Outcome measures

Measure	Total Recruitment Sample, Pre-Assignment n=34 Participants All participants who filled out the online pre-screening interest survey, including those were later 1) excluded from the study before assignment to groups due to not meeting eligibility criteria or completing the consent process, and 2) randomly assigned into the yoga intervention group and control group arms.	Control Group n=34 Participants Control participants will receive no guidance from the research staff to change their behavior.
Perceived Stress Baseline	2.9 score on a scale Standard Deviation 0.4	2.8 score on a scale Standard Deviation 0.5
Perceived Stress Post-Intervention	2.6 score on a scale Standard Deviation 0.4	2.6 score on a scale Standard Deviation 0.5
Perceived Stress Follow-Up	2.7 score on a scale Standard Deviation 0.5	2.7 score on a scale Standard Deviation 0.6

Adverse Events

Yoga Intervention Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Yoga Intervention Group n=33 participants at risk 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).

Musculoskeletal and connective tissue disorders Mild Adverse Event

3.0% 1/33 • Number of events 1 • 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.

Additional Information

Dr. Daheia J. Barr-Anderson

University of Minnesota

Phone: 240-475-2806

Email: barra027@umn.edu

Results disclosure agreements

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