Place Activation in Urban Peripheries: the 'Comunidades y Espacios Activos" Project (CEA)

Not Applicable

Recruiting

• Conditions: Uptake of Systematic Review Evidence

• Registration Number: NCT06999382
• Lead Sponsor: University of Texas at Austin

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-05-22
• Study First Posted: 2025-05-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-03
• Last Update Posted: 2025-06-06
• Study Start: 2025-10-01
• Primary Completion: 2028-12-31
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reach	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)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Adoption (group-level)	Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)	Operationalized as confirmed adoption of evidence-based interventions at the neighborhood level. Assessed via policy document audits that my indicate a new program in place in the area or budget allocation for a given program; as well as by direct observation of public open spaces to confirm that a given intervention is taking place; and through intercept surveys to fully identifiable public open space users that report if to their knowledge any evidence-based intervention is ongoing in their neighborhood (analyzed at the group level for the given public open space where data were collected at each time point).
Implementation (group-level)	Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)	Operationalized as the extent to which evidence-based interventions that have been adopted in a given neighborhood are taking place with close fidelity to the interventions that were developed and tested in research settings as reported by peer-reviewed literature. Measured via direct observation of public open spaces in participating neighborhoods, through direct observation checklists.
Real world effectiveness (physical activity)	Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)	Measured by direct observation of public open spaces in participating neighborhoods, through the System for Observing Play and Recreation in Communities (SOPARC), a valid and reliable method utilizing spatial and momentary sampling assessments, measuring the number of total and physically active users of public open spaces. These data are then used to estimate group-based MET-minutes at a given point in space and time.

Trial Locations

Locations (1)

Instituto Nacional de Salud Publica; 🇲🇽 Cuernavaca, Morelos, Mexico