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临床试验/NCT05702346
NCT05702346撤回不适用

A Multi-level Telehealth Intervention to Enhance Physical Activity in Low-income Black and Hispanic Adults

Boston University Charles River Campus0 个研究点目标入组 300 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
300
主要终点
Objectively measured Physical activity

研究概览

简要总结

The present study aims to test the efficacy of a multi-level telehealth intervention to Enhance Physical Activity (EPA) in 300 low-income Black and Hispanic/Latino adults. EPA is eight weeks with four weekly, hour-long parts: virtual group exercises, virtual group discussions, individual PA participation, and individual phone check-ins. A control group will receive health education. The specific aims are to: 1) test if physical activity increases significantly more among participants assigned to EPA vs. wait-list controls and 2) test if physical function improves significantly more among participants in EPA vs. controls. An exploratory third aim will test mechanisms of change associated with EPA.

详细描述

In the U.S., 77% of Black and 79% of Hispanic/Latino (HLs) adults do not meet physical activity (PA) guidelines to engage in moderate to vigorous PA for 150 minutes each week compared to 73% of White adults. Low PA leads to chronic conditions such as cardiovascular disease, type 2 diabetes, and obesity that result in disability and premature death. For Black and HL adults, low PA compounds predispositions to these conditions. Despite the urgent need to increase PA among Black and HL adults, solutions to increase PA are not tailored to this population. Poverty is more than double for Black (19.5%) and HLs (17%) compared to non-HL White adults (8.2%) and meeting PA standards increases with income. Lack of access to costly exercise facilities and living in unsafe neighborhoods contribute to low PA among Black and HL adults. As an alternative to traditional approaches, virtual guidance (i.e., telehealth) is a feasible and effective way to overcome the lack of access to facilities and PA participation in unsafe environments. The present study aims to test the efficacy of a multi-level telehealth intervention to Enhance Physical Activity (EPA) in 300 low-income Black and HLs. This full-scale, well-powered efficacy study builds on a Phase 1 pilot-controlled trial of EPA that showed high feasibility and acceptability in low-income Black and HLs. EPA is eight weeks with four weekly, hour-long parts: virtual group exercises, virtual group discussions, individual PA participation, and individual phone check-ins. Using a socio-ecological model of behavior change, EPA addresses PA and physical function at both intrapersonal (individual PA participation and individual phone check-ins) and interpersonal (virtual group exercises and virtual group discussions) levels. A control group will receive health education with the option to receive EPA later. All participants will attend four visits: pre-test, post-test 1 after EPA, post-test 2 (6 months after post-test 1), and post-test 3 (12 months after post-test 1). EPA is unique compared to other PA interventions as it combines standard PA intervention components with factors vital for increasing PA in Black and HLs while leveraging social connection: culturally relevant support, group discussions targeting discrimination, a telehealth format accessible to low-income people, and activities using everyday items or body weight to account for lack of equipment. The specific aims are to: 1) test if PA increases significantly more among participants assigned to EPA vs. wait-list controls and 2) test if physical function improves significantly more among participants in EPA vs. controls. An exploratory aim is to test mechanisms of change associated with EPA. Based on the sociocultural component of the National Institute on Minority Health and Health Disparities Research Framework, we hypothesize that social connection will mediate PA and physical function outcomes for those who receive the EPA intervention. This research can elucidate behavioral mechanisms responsible for low PA in low-income Black and HL adults and lead to scalable and sustainable multi-level interventions to support increased PA for Black and HL communities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • being between 40-70 years old
  • ability to speak and read English or Spanish
  • ability to comply with study procedures and schedule
  • having <150 minutes of weekly physical activity
  • willingness to give informed consent

排除标准

  • not independently ambulatory
  • having other serious health problems that would make it difficult to participate for the duration of the study

研究组 & 干预措施

Intervention

Experimental

Participants will receive the EPA intervention.

干预措施: Enhance Physical Activity (EPA) (Behavioral)

Control

Active Comparator

This is the control group who will receive written information about health.

干预措施: Enhance Physical Activity (EPA) (Behavioral)

结局指标

主要结局

Objectively measured Physical activity

时间窗: 12 months

accelerometers

Self-Reported Physical activity

时间窗: 12 months

physical activity via the Physical Activity Scale for the Elderly

Physical function

时间窗: 12 months

physical function via the Short Physical Performance Battery

次要结局

  • Strength(12 months)
  • Social connection(12 months)
  • Social determinants of health(12 months)

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Sponsor
主要研究者

Simone V. Gill

Associate Professor

Boston University Charles River Campus

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