Harmony & Health: Feasibility of a Movement Intervention to Improve Psychosocial Wellbeing in Black Adults in Northeast Texas
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility and acceptability of the intervention: Program satisfaction
研究概览
简要总结
To test the feasibility and acceptability of a program that combines yoga practices and Christian spirituality (called Harmony & Health) amongst insufficiently active Black adults.
详细描述
Objectives
Primary Objective:
The primary objective of this 2-arm randomized controlled pilot study is to test the feasibility and acceptability of HH in Black adults residing in rural areas surrounding Tyler in Northeast Texas. Black adults who are insufficiently active will be randomized to the HH intervention or an attention control group. We hypothesize that we will meet our recruitment goal of 50 participants over 5 months, ≥80% of participants will be retained at post-intervention and follow up, and ≥80% will adhere to sessions.
Secondary Objectives:
The secondary objectives of this study are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥18 years of age
- •Self-identify as Black or African American
- •Able to read, speak, and write in English
- •Primary residence in the Northeast Texas area (Public Health Region 4/5N)
- •Insufficiently active (self-report <75 minutes/week of physical activity)
- •Sedentary (self-report ≥6 hours/day of sitting time)
- •Body mass index [BMI] ≥25 kg/m2
- •Able to pass the Physical Activity Readiness Questionnaire (PARQ) or provide physician's clearance to participate
- •Able to provide written informed consent without assistance
排除标准
- •<18 years of age
- •Do not self-identify as Black or African American
- •Unable to read, speak, and write in English
- •Primary residence falls outside of the Northeast Texas area or Public Health Region 4/5N
- •Physically active or self-report doing ≥75 minutes/week of physical activity
- •Not sedentary or self-report <6 hours/day of sitting time
- •BMI <25.0 kg/m2
- •Absolute contraindications to unassisted physical activity based on the PARQ (e.g., acute MI, orthopedic and musculoskeletal limitations)
- •Planning to move from the Northeast Texas during the 6 month study period
- •Pregnant or planning to become pregnant during the 6 month study period
- •Currently participating in another program to increase physical activity, reduce sedentary behavior, or manage weight
研究组 & 干预措施
Health and Harmony
Participants will take part in a program combining yoga practices and Christian spirituality.
干预措施: Harmony & Health (Behavioral)
Health and Harmony
Participants will take part in a program combining yoga practices and Christian spirituality.
干预措施: Health Education (Behavioral)
Health Education (Control)
Participants will take part in a series of health education sessions.
干预措施: Harmony & Health (Behavioral)
Health Education (Control)
Participants will take part in a series of health education sessions.
干预措施: Health Education (Behavioral)
结局指标
主要结局
Feasibility and acceptability of the intervention: Program satisfaction
时间窗: through study completion; an average of 1 year.
Following the follow-up data collection time point, we will conduct individual interviews with a subsample of participants (\~16 participants). Interview questions will address participants' overall reactions to and satisfaction with the mind-body intervention, perceived impact on social support, motivation, and self-efficacy for increase physical activity and well-being. Positive satisfaction, i.e., successful feasibility, will be achieved when participants consistently and repeatedly, through subsequent interviews, endorse satisfaction with the program through use of positive language when describing their feelings toward the program. Interviews will be conducted by the PI or trained member of the research team.
Feasibility and acceptability of the intervention: Recruitment and retention
时间窗: through study completion; an average of 1 year.
Rates of study eligibility, recruitment, and retention will be assessed. We will maintain detailed information during the recruitment process regarding the number of church members interested, eligible, ineligible and reasons for ineligibility, and enrolled. To assess feasibility, we will calculate the rates of study eligibility, recruitment, and retention, along with their 90% confidence intervals (CIs). Participant feedback will be summarized using means and standard deviations along with graphical display (e.g., box plots). Recruitment success, i.e., feasibility will be achieved if ≥50% of eligible participants enrolls in the study. Retention success will be achieved if ≥80% participants complete the post-intervention and follow-up assessments.
次要结局
未报告次要终点