Feasibility of a Yoga Intervention in Sedentary African-American Women

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

Time frame: 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 post-intervention assessments.

Time frame: 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% intervention and control participants will complete baseline assessments.

Time frame: 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% (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

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).

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

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.

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

Time frame: 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.

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)

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.

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

Time frame: 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.

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

Time frame: 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% 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

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).

Time frame: 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).

Time frame: 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 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)

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.

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)

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

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.

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.

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)

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.