Uptake of Systematic Review EvidenceCEANCT06999382
Place Activation in Urban Peripheries: the 'Comunidades y Espacios Activos" Project (CEA)
A study testing Active Dissemination and Implementation and Passive Dissemination in people with Uptake of Systematic Review Evidence, run by Deborah Salvo at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Uptake of Systematic Review Evidence
- What is being tested?
- Active Dissemination and Implementation and Passive Dissemination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteMexico
- Study dates
- 16 Feb 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Salud Publica
Cuernavaca, Morelos, 62100
Alejandra Jauregui de la Mota, PhD, 52-777-3293000 ext. 7409, alejandra.jauregui@insp.mx
Alejandra Jauregui de la Mota, PhD
About this study
Official title: Contextually Responsive Implementation of Place-Activation Interventions for Promoting Physical Activity in Low-Income Urban Communities
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).
Read the 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.
- Conditions
- Uptake of Systematic Review Evidence
- Being tested
- Active Dissemination and Implementation, Passive Dissemination
- Keywords
- dissemination and implementation, place-activation, urban health, built environment, physical activity, contextual adaptations
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Dissemination and ImplementationBehavioural
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 DisseminationBehavioural
Delivery of booklet with menu of evidence-based interventions for place-activation; and of pamphlet summarizing importance of healthy lifestyle promotion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Passive Dissemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)
Secondary outcomes (3)
Adoption (group-level)
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).
Measured: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)
Implementation (group-level)
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.
Measured: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)
Real world effectiveness (physical activity)
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.
Measured: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start16 Feb 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uptake of Systematic Review EvidenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deborah Salvo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), The University of Texas Health Science Center, Houston, Washington University School of Medicine, Instituto Nacional de Salud Publica, Mexico
- Responsible party
- Sponsor-investigator, Deborah Salvo, University of Texas at Austin
- Investigators
- Deborah Salvo, PhD, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999382
- Sponsor's protocol ID
- UTexasAustin-STUDY00005076
- Other IDs
- R01MD019155
- Acronym
- CEA
- Status last verified
- Apr 2026
- First submitted
- 22 May 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Longitudinal prospective data on a cohort of 510 community members and stakeholders, with measurements at baseline, and follow-ups at 6, 12, and months, will be collected using questionnaires. In addition, the project will provide longitudinal observation data collected annually in 30 public open spaces and cross-sectional panel data from up to 4,500 intercept surveys across the study duration (24 months).
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contextually Responsive Implementation of Place-Activation Interventions for Promoting Physical Activity in Low-Income Urban Communities
- ClinicalTrials.gov ID
- NCT06999382
- Acronym / sponsor ID
- CEA / UTexasAustin-STUDY00005076
- Conditions
- Uptake of Systematic Review Evidence
- Keywords
- dissemination and implementation, place-activation, urban health, built environment, physical activity, contextual adaptations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Deborah SalvoUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), The University of Texas Health Science Center, Houston, Washington University School of Medicine, Instituto Nacional de Salud Publica, Mexico
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active 'Dissemination and Implementation' Place-Activation Intervention | Experimental | Behavioral: Active Dissemination and ImplementationIntervention 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. |
| Comparison | Active comparator | Behavioral: Passive DisseminationImplementation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Dissemination and ImplementationThis 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. | Behavioural | Active 'Dissemination and Implementation' Place-Activation Intervention |
| Passive DisseminationDelivery of booklet with menu of evidence-based interventions for place-activation; and of pamphlet summarizing importance of healthy lifestyle promotion. | Behavioural | Comparison |
Primary outcome
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).
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.
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. Longitudinal prospective data on a cohort of 510 community members and stakeholders, with measurements at baseline, and follow-ups at 6, 12, and months, will be collected using questionnaires. In addition, the project will provide longitudinal observation data collected annually in 30 public open spaces and cross-sectional panel data from up to 4,500 intercept surveys across the study duration (24 months).
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deborah Salvo, PhD principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Dissemination and Implementation and Passive Dissemination in people with Uptake of Systematic Review Evidence, run by Deborah Salvo at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Salvo, PhD (512-471-8599, dsalvo@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: Measured at baseline, 6-months (interim effects), 12-months (post-intervention), 24-months (maintenance)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.