Clinical trial NCT06999382: Place Activation in Urban Peripheries: the 'Comunidades y Espacios Activos" Project (CEA)
Official title: Contextually Responsive Implementation of Place Activation Interventions for Promoting Physical Activity in Marginalized Urban Peripheries in Mexico
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uptake of Systematic Review Evidence
Keywords: dissemination and implementation
place-activation
urban health
built environment
physical activity
contextual adaptations
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: The University of Texas Health Science Center, Houston
name: Washington University School of Medicine
name: Instituto Nacional de Salud Publica, Mexico
First posted: 2025-05-31
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Reach
timeFrame: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)
measure: Adoption (self-reported by implementation partners)
timeFrame: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)
measure: Implementation (self-reported)
timeFrame: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)
Secondary outcomes:
measure: Adoption (group-level)
timeFrame: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)
measure: Implementation (group-level)
timeFrame: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)
measure: Real world effectiveness (physical activity)
timeFrame: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)
Other outcomes:
Locations:
city: Cuernavaca
country: Mexico
facility: Instituto Nacional de Salud Publica
state: Morelos
Study officials:
affiliation: The University of Texas at Austin
name: Deborah Salvo, PhD
role: PRINCIPAL_INVESTIGATOR
References: