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NCT Number: NCT06999382

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

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).

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Key information

Conditions

Uptake of Systematic Review Evidence Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Salud Publica

Cuernavaca, Morelos, 62100, Mexico

Location status: Recruiting

Location contact

Alejandra Jauregui de la Mota, PhD

CONTACT

[email protected]

52-777-3293000 ext. 7409

Alejandra Jauregui de la Mota, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Passive Dissemination

Behavioral

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

Primary outcomes

  1. Reach

    Time frame: 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).

  2. Adoption (self-reported by implementation partners)

    Time frame: 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.

  3. Implementation (self-reported)

    Time frame: 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 outcomes

  1. Adoption (group-level)

    Time frame: 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).

  2. Implementation (group-level)

    Time frame: 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.

  3. Real world effectiveness (physical activity)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Deborah Salvo, PhD

CONTACT

[email protected]

512-471-8599

Sponsors and collaborators

Lead sponsor

Deborah Salvo

Other

Collaborators

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

Registry information

Official study title

Contextually Responsive Implementation of Place-Activation Interventions for Promoting Physical Activity in Low-Income Urban Communities

Acronym: CEA

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 31, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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