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临床试验/NCT05147298
NCT05147298进行中(未招募)不适用

Multilevel Physical Activity Intervention for Low Income Public Housing Residents

Tufts Medical Center2 个研究点 分布在 1 个国家目标入组 543 人开始时间: 2022年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
543
试验地点
2
主要终点
Change in minutes of light, moderate, and vigorous intensity physical activity per day at 12 months

研究概览

简要总结

This research study will investigate the independent effects of an environmental intervention (E only), an individual-level eHealth phone program intervention (I only), or both (E+I) on changes in moderate intensity physical activity. A cluster randomized design will be implemented whereby all residents of one of 12 of Boston's public housing developments (PHDs) will be randomized to one of the four study groups (E only, I only, E+I, or control). The activities with this multilevel design include:

  • Screening/enrollment/baseline assessment activities
  • Environmental components to promote moderate intensity walking and other physical activity at the PHDs
  • Changing the environment surrounding the development making it more amenable to walking through the creation of walking trails and walking maps; and advocating for changes to the built environment
  • Healthy Living Advocates (HLA)-led walking groups within the community
  • Individual level components to increase motivation and self-efficacy for physical activity
  • eHealth program, an automated telephone-based physical activity program
  • 12-month and 24-month follow up assessment activities

The investigators hypothesize that the participants living in the PHDs in any of the three intervention groups (E only, I only, and E+I combined) will increase minutes of moderate intensity physical activity more than participants in control group developments at 24-month follow up. It is further expected that delivery of an intervention package targeting environmental and social cues to become active, combined with an individual level intervention, will improve overall physical activity levels to recommended guidelines at the development level. The findings will inform future health promotion efforts among residents in public housing developments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
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

入选标准

  • Willing to wear device to track physical activity during assessment periods
  • Able to speak English or Spanish
  • Current resident of Boston Public Housing Development or housing property on Boston Housing Authority owned land
  • No plans to move within the next 2 years
  • Has access to a phone (of any kind)

排除标准

  • Currently enrolled in a research study about physical activity that is incompatible with study participation
  • Unable to provide informed consent in judgement of research assistant

结局指标

主要结局

Change in minutes of light, moderate, and vigorous intensity physical activity per day at 12 months

时间窗: baseline, 12 months

Assessed by (1) evaluating the proportion of accelerometers distributed and returned, (2) downloading the data from the devices, (3) processing the data (e.g., removing outliers), and (4) examining the proportion that have valid data (i.e., minimum 3 days of wear).

Change in minutes of light, moderate, and vigorous intensity physical activity per day at 24 months

时间窗: baseline, 24 months

Assessed by (1) evaluating the proportion of accelerometers distributed and returned, (2) downloading the data from the devices, (3) processing the data (e.g., removing outliers), and (4) examining the proportion that have valid data (i.e., minimum 3 days of wear).

次要结局

  • Evaluate the mediator effects of motivation(baseline, 12 months, 24 months)
  • Evaluate the mediator effects fidelity to the interventions(baseline, 12 months, 24 months)
  • Evaluate the mediator effects of self-efficacy(baseline, 12 months, 24 months)
  • Evaluate the mediator effects of neighborhood walkability(baseline, 12 months, 24 months)
  • Evaluate the mediator effects of support from HLAs(baseline, 12 months, 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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