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

NCT06999382 | Recruiting

• 2 other identifiers: UTexasAustin-STUDY00005076R01MD019155
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

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).

Conditions

Uptake of Systematic Review Evidence

Keywords

dissemination and implementation; place-activation; urban health; built environment; physical activity; contextual adaptations

Outcome Measures

Primary Outcomes (3)

• Reach

  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).

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

• Adoption (self-reported by implementation partners)

  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.

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

• Implementation (self-reported)

  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.

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

Secondary Outcomes (3)

• 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)

Study Arms (2)

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.

Behavioral: Active Dissemination and Implementation

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.

Behavioral: Passive Dissemination

Interventions

Active Dissemination and Implementation BEHAVIORAL

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 their willingness to adopt and implement them in their neighborhood settings. Intervention components include capacity building workshops, newsletters, targeted messaging and access to a knowledge broker and implementation support for 1-year.

Active 'Dissemination and Implementation' Place-Activation Intervention

Passive Dissemination BEHAVIORAL

Delivery of booklet with menu of evidence-based interventions for place-activation; and of pamphlet summarizing importance of healthy lifestyle promotion.

Comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• years or older
• Located within the confines of the public open space being assessed in a study neighborhood at time of direct observation assessments.

Sponsors & Collaborators

• Deborah Salvo: lead
• The University of Texas Health Science Center, Houston: collaborator
• Washington University School of Medicine: collaborator
• Instituto Nacional de Salud Publica, Mexico: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Instituto Nacional de Salud Publica

Cuernavaca, Morelos, 62100, Mexico

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Deborah Salvo, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Salvo, PhD

CONTACT

512-471-8599; dsalvo@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Kinesiology and Health Education

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: February 16, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available at the time of associated publication. The data submission and release timeframes specified by the funding agency and policies, as described on NIH's data sharing webpage, will be met. Study data deposited in the indicated repository or repositories will be available to the research community for a minimum of 7 years post-project end period or as long as administratively valuable per UT Austin data retention policies, plus any additional time required by the specific funding agency.
• Access Criteria: Datasets will be findable and identifiable in ICPSR's database through a study digital object identifier (DOI) minted by ICPSR.

Locations

ME (1)