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

The University of Texas System (UT)

Status: Enrolling

Conditions: Uptake of Systematic Review Evidence

Treatments: Behavioral: Active Dissemination and Implementation; Behavioral: Passive Dissemination

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06999382

R01MD019155 (U.S. NIH Grant/Contract)

UTexasAustin-STUDY00005076

Details and patient eligibility

About

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).

Full 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.

Enrollment: 510 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria 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).

Exclusion Criteria 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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510 participants in 2 patient groups

Active 'Dissemination and Implementation' Place-Activation Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Active Dissemination and Implementation

Comparison

Active Comparator group

Description:

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.

Treatment:

Behavioral: Passive Dissemination