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 Low-Income Urban Communities

Overview

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.

Interventions

• Behavioral Active Dissemination and Implementation
  This intervention is designed to accelerate the uptake of evidence-based interventions that help maximize the impact of the addition or renovation of public open spaces on their utilization for active recreation among community members, ultimately effective physical activity levels in communities. The intervention targets implementation partners: local stakeholders/decision makers and community leaders, to increase their awareness of these evidence-based approaches for place-activation, and thei
• Behavioral Passive Dissemination
  Delivery of booklet with menu of evidence-based interventions for place-activation; and of pamphlet summarizing importance of healthy lifestyle promotion.

Primary outcome measures

• Reach [Time frame: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)]
• Adoption (self-reported by implementation partners) [Time frame: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)]
• Implementation (self-reported) [Time frame: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)]

Secondary outcome measures (3)

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Mexico · 1 center

• Instituto Nacional de Salud Publica — Cuernavaca

Identifiers

NCT: NCT06999382 · UTexasAustin-STUDY00005076 · R01MD019155

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗