Feasibility of a Yoga Intervention in Sedentary African-American Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Rating of Assessment Measures (Feasibility)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rating of Assessment Measures (Feasibility)
时间窗: 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)
时间窗: 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)
时间窗: During the 12-week yoga intervention
At least 80% of intervention participants attend at least 80% of intervention sessions
Fidelity of Intervention Delivery (Feasibility)
时间窗: 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)
时间窗: 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)
时间窗: During the 12-week yoga intervention
100% of intervention materials and resources are delivered as planned to intervention participants.
Number of Adverse Events (Safety)
时间窗: 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)
时间窗: 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)
时间窗: 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)).
次要结局
- Sedentary Behavior(Seven consecutive days at three time points: baseline before intervention, post-intervention (within 2 months), and 3-month follow-up.)
- Perceived Stress(Surveys will be distributed at each data collection timepoint (baseline, post-intervention (within 2 months), and 3 month follow-up))
- 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))