Feasibility of a Yoga Intervention in Sedentary African-American Women
- Conditions
- Sedentary Behavior
- Interventions
- Behavioral: Yoga Intervention
- Registration Number
- NCT04710979
- Lead Sponsor
- University of Minnesota
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 69
- Self-identified as an African-American woman at least 18 years old
- Engaging in less than 30 minutes/week of moderate-to-vigorous physical activity
- If employed, working in a sedentary occupation that requires primarily seated work; • If unemployed, typical day involves sedentary, primarily seated activities
- Able to exercise for 20 minutes continuously
- No pre-existing condition that limits physical activity
- Access to a computer (or mobile device) and internet service
- Diagnosed with heart disease, diabetes, cancer, kidney, liver disease, major depression or bipolar disease
- Take more than two daily medications for lipids or blood pressure
- Current smoker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Yoga Intervention Group Yoga Intervention -
- Primary Outcome Measures
Name Time Method Rating of Assessment Measures (Feasibility) 3-month follow-up 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).
Completion of Assessment Measures (Feasibility) 3-month follow-up At least 90% of intervention and control participants will complete 3-month follow-up assessments.
Rate of Participant Retention and Adherence (Feasibility) During the 12-week yoga intervention At least 80% of intervention participants attend at least 80% of intervention sessions
Fidelity of Intervention Delivery (Feasibility) During the 12-week yoga intervention At least 90% (8 of 9 class segments) of each of the 6 videotaped sessions is delivered as planned based on training.
Number of Participants Recruited (Feasibility) Baseline Goals were for 200 women recruited and screened for eligibility, and 60 enrolled and consented.
Rate of Delivery of Intervention Materials and Resources (Feasibility) During the 12-week yoga intervention 100% of intervention materials and resources are delivered as planned to intervention participants.
Number of Adverse Events (Safety) During the 12-week yoga intervention 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)
Rating of Intervention Components (Acceptability) Post-intervention (within 2 months) 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).
Participant Rating of Yoga Intervention (Acceptability) Post-intervention (within 2 months) 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)).
- Secondary Outcome Measures
Name Time Method Sedentary Behavior Seven consecutive days at three time points: baseline before intervention, post-intervention (within 2 months), and 3-month follow-up. 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.
Perceived Stress Surveys will be distributed at each data collection timepoint (baseline, post-intervention (within 2 months), and 3 month follow-up) 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.
Systolic and Diastolic Blood Pressure 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) 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.
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States