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临床试验/NCT05922943
NCT05922943进行中(未招募)不适用

Harmony & Health: A Culturally Adapted Mindbody Intervention to Reduce Sitting Time and Improve Psychosocial Wellbeing in Black Adults

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2024年8月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
251
试验地点
1
主要终点
Quality of life questionnaires

研究概览

简要总结

This community-based study will assess the efficacy of a culturally adapted, yoga-based intervention to reduce sitting time, increase physical activity, and improve psychosocial wellbeing among insufficiently active Black adults in the Houston area.

详细描述

Primary Objectives:

--The primary aim of the proposed study is to determine the efficacy of HH in reducing sitting time and increasing physical activity in insufficiently active Black adults. Hypothesis: HH participants will spend less time sitting and more time moving at post-intervention (week 9) compared to participants in the attention control group.

Secondary Objectives:

The secondary aims of this proposed study are to:

  • Examine the effects of HH on psychosocial wellbeing and the association of psychosocial wellbeing with behavioral outcomes. Hypothesis: HH participants will report improved psychosocial wellbeing, including reduced stress, depressive symptoms, and negative affect and improved quality of life, which will in turn mediate intervention outcomes at post-intervention (week 9) and follow up (week 24).
  • Evaluate the long-term benefits of the HH intervention. Hypothesis: HH participants will spend less time sitting and more time moving at follow up (week 24) compared to participants in the attention control group.

研究设计

研究类型
Interventional
分配方式
Na
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 18 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults ≥18 years old
  • •Self-identify as Black or African American
  • •Self-reports MVPA <150 minutes/week
  • •Self-reports sedentary time ≥6 hours/ day
  • •Body mass index [BMI] ≥25.0 kg/m2 based on self-reported height and weight (and verified at baseline)
  • •Able to pass the modified Physical Activity Readiness Questionnaire (PAR-Q) or provide physician's clearance to participate
  • •Willing to be randomized to intervention or control
  • •Comfortable participating in group-based physical activity
  • •Able to read, speak, and write in English
  • •Able to provide written informed consent without assistance

排除标准

  • •< 18 years old
  • •Self-reports MVPA .150 minutes/week
  • •Self-reports sedentary time <6 hours/day
  • •Not classified as overweight or obese (BMI <25.0 kg/m2)
  • •Absolute contraindications to unassisted physical activity (e.g. acute MI, orthopedic and musculoskeletal limitations)
  • •Practicing yoga or enrolled in another program targeting physical activity, sedentary behavior, or weight loss in the last 6 months
  • •Previously participated in Harmony & Health
  • •Pregnant or planning to become pregnant in the next 6 months
  • •Planning to move from the Houston area within the next 6 months

研究组 & 干预措施

Harmony & Health program

Experimental

Participants will take part in the Harmony & Health program or participants will attend in-person group health education sessions 2 times a week for 8 weeks.

干预措施: Harmony & Health program (Behavioral)

结局指标

主要结局

Quality of life questionnaires

时间窗: through study completion; an average of 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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