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临床试验/NCT06999382
NCT06999382招募中不适用

Contextually Responsive Implementation of Place-Activation Interventions for Promoting Physical Activity in Low-Income Urban Communities

Deborah Salvo1 个研究点 分布在 1 个国家目标入组 510 人开始时间: 2026年2月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Deborah Salvo
入组人数
510
试验地点
1
主要终点
Reach

研究概览

简要总结

This study will use a Hybrid III Cluster-Randomized Controlled Trial to test an 'active dissemination and implementation' intervention in peripheral urban neighborhoods, designed to accelerate the uptake of evidence-based place-based activations that are known to be effective in increasing physical activity among local residents. The study will use a parallel design with eligible neighborhoods randomized to one of two arms: the (1) "Active Dissemination and Implementation" intervention arm (n=15 neighborhoods); and (2) the comparison arm (n=15 neighborhoods). Participants will be "implementation partners" in each of the participating neighborhoods (n=510 total participants, n=17 per neighborhood), comprised of a mix of local government representatives, representatives of non-governmental organizations working in the area, and community leaders. Intervention components to be delivered to implementation partners of neighborhoods randomized to the "Active Dissemination and Implementation" Intervention Arm include participation in 2 workshops, facilitation of coalition building activities, newsletters, targeted messaging, and access to a knowledge broker, and implementation support for 1 year (12 months).

详细描述

A group-randomized hybrid III trial (Aim 2) testing the effectiveness of a 1-year 'active dissemination and implementation' intervention in increasing the reach, adoption, and implementation fidelity (primary outcomes); and the real-world effectiveness (secondary outcome) of contextually relevant place-activation evidence-based interventions. 30 urban peripheral neighborhoods with recently completed open public space improvements will be selected and randomized within pairs to the intervention vs. comparison condition (15 in each arm). Participants (n=510 total, n=17 per neighborhood) will be community leaders and local-level stakeholders with authority over or engagement with the public open space being assessed. Intervention conditions include capacity-building activities for participants, and intervention implementation support for 1-year, which are hypothesized to improve adoption, reach, and implementation fidelity of place-activation evidence-based interventions.

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
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
是

入选标准

  • •for Implementation Partners (main sample for primary Outcomes):
  • •Adults 18 years of age or older
  • •Stakeholders (government or nongovernmental organization representatives in sectors such as health, education, air quality, economic development, urban planning, transportation, parks and recreation, public safety, etc.) or community leaders of peripheral urban neighborhoods of study cities (10 possible cities in Mexico: Colima, Merida, Monterrey, Toluca, Mexico City, Guadalajara, Tijuana, Leon, Cuernavaca, Tapachula).

排除标准

  • •for Implementation Partners (main sample of primary outcomes):
  • •Not meeting any of the inclusion criteria.
  • •Inclusion Criteria for Intercept Survey Participants (for secondary outcomes):
  • •18 years or older
  • •Located within the confines of the public open space being assessed in a study neighborhood at time of direct observation assessments.
  • •Exclusion Criteria for Intercept Survey Participants (for secondary outcomes):
  • •Not meeting any of the inclusion criteria.

研究组 & 干预措施

Active 'Dissemination and Implementation' Place-Activation Intervention

Experimental

Intervention conditions include capacity-building activities for participants (who are defined as "implementation partners" - i.e., local stakeholders/decision makers and community leaders in the intervention neighborhoods), as well as evidence-based intervention implementation support for 1-year, which are hypothesized to improve adoption, reach, and fidelity of place-activation evidence-based interventions in urban settings. Activities include workshops, facilitation of coalition building activities, newsletters, targeted messaging, and access to a knowledge broker.

干预措施: Active Dissemination and Implementation (Behavioral)

Comparison

Active Comparator

Implementation Partners in neighborhoods randomized to the active comparator arm will receive a booklet denominated a "menu of evidence-based interventions for place-activation to promote physical activity in urban settings", summarizing evidence-based approaches known to work to activate recently renovated or added public open spaces. They will also receive a pamphlet with information on the importance of healthy lifestyle promotion.

干预措施: Passive Dissemination (Behavioral)

结局指标

主要结局

Reach

时间窗: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)

Operationalized as awareness of evidence-based interventions, and measured with surveys utilizing 5-Point Likert scale questions (Range: 1-5, where 5 is highest awareness).

Adoption (self-reported by implementation partners)

时间窗: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)

Operationalized as the confirmed adoption of evidence-based interventions (binary variable: yes or no for each evidence-based intervention that could be adopted). Confirmation of adoption is assessed via surveys to implementation partners, who respond to questions about whether the neighborhood they operate at has begun utilizing each of the specific evidence-based interventions or not.

Implementation (self-reported)

时间窗: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)

Operationalized as implementation fidelity, as reported by the implementation partner participants - i.e., to what extent is each of the evidence-based interventions that were adopted in a given neighborhood been implemented with close fidelity to the research-based intervention with proven effectiveness per the scientific literature. Implementation fidelity is measured with self-reported checklists.

次要结局

  • Adoption (group-level)(Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance))
  • Implementation (group-level)(Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance))
  • Real world effectiveness (physical activity)(Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance))

研究者

发起方
Deborah Salvo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Deborah Salvo

Associate Professor of Kinesiology and Health Education

University of Texas at Austin

研究点 (1)

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