- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07780825
Neighborhood Connect
18 de agosto de 2026 actualizado por: Stephenie Lemon, University of Massachusetts, Worcester
Prevention Research Center at UMass Chan
The study is evaluating the effectiveness of an implementation strategy called Neighborhood Connect, which is designed to support residents' engagement in activities that improve the attractiveness, safety and livability of Worcester, MA neighborhoods.
The program focuses on the built environment (i.e., the human-made, physical surroundings of Worcester neighborhoods including indoor public places and outdoor spaces like parks, streets and sidewalks) and aims to build capacity of community members to strengthen their neighborhoods.
Participants will include residents and others who care about local built environment conditions.
Neighborhood Connect is delivered by a built environment specialist from the local health department in collaboration with a statewide coalition.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
The study is the core research project of the Prevention Research Center at UMass Chan.
Under the guidance of a Community Advisory Board, the program aims to build capacity of the local health department and local residents to influence built environment change in neighborhoods.
The program includes a training and technical assistance approach.
The local health department built environment specialist learns about the built environment and how to determine how related decisions are made.
The built environment specialist delivers the Zoom-based group program for residents.
This six session training and technical assistance model includes 3 components: Connect with Community, Connect with Environment and Connect with Process.
Through Neighborhood Connect's structured learning and applied activities, participants: Strengthen interpersonal connections and social networks within neighborhoods, Explore their neighborhoods and identify their priorities for change or improvement, Learn how decision-making processes affect their communities and Collaborate on ideas for small-scale neighborhood improvements.
The implementation strategy is being evaluated in a mixed methods study.
Through a stepped wedge design with 8 waves (neighborhood/area) rolled out in 4 steps (2 neighborhoods/areas per wave), the resident-focused component of Neighborhood Connect is being evaluated.
Both the resident and health department components are being evaluated using qualitative methods.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
240
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Stephenie C Lemon, PhD, MS
- Número de teléfono: 15088564098
- Correo electrónico: Stephenie.Lemon@Umassmed.edu
Ubicaciones de estudio
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01655
- Reclutamiento
- University of Massachusetts Chan Medical School
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Contacto:
- Stephenie C Lemon, PhD, MS
- Número de teléfono: 5088261325
- Correo electrónico: Stephenie.Lemon@Umassmed.edu
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Live, work or have other connection to specific areas of Worcester, MA;
- Speak English or Spanish
Exclusion Criteria:
- Don't speak English or Spanish;
- Have a cognitive deficit that precludes participation
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Neighborhood Connect implementation strategy
All participants receive the Neighborhood Connect implementation strategy.
It is deployed to all participants in a given wave (neighborhood/area) at once.
Order of implementaiton of the intervention is determined by neighborhood/area-level randomization.
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Neighborhood Connect is an implementation strategy designed to prepare participants to make built environment changes that promote healthy communities, including social connectedness, physical activity, traffic safety, etc.
The program is generic and allows participants to identify their own priorities for built environment change.
The curriculum includes six Zoom-based educational sessions delivered by a built environment specialist with a member of a walking coalition, participation in a neighborhood audit, creation of a plan for change and ability to receive technical assistance after the formal program is completed.
The built environment specialist receives training and technical assistance for leading the resident-focused implementation strategy.
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|
Otro: Pre-implementation
Within this stepped wedge design, each individual serves as their own comparator.
Data from the pre-implementation phase will be collected for this purpose.
|
Neighborhood Connect is an implementation strategy designed to prepare participants to make built environment changes that promote healthy communities, including social connectedness, physical activity, traffic safety, etc.
The program is generic and allows participants to identify their own priorities for built environment change.
The curriculum includes six Zoom-based educational sessions delivered by a built environment specialist with a member of a walking coalition, participation in a neighborhood audit, creation of a plan for change and ability to receive technical assistance after the formal program is completed.
The built environment specialist receives training and technical assistance for leading the resident-focused implementation strategy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Built environment actions
Periodo de tiempo: Baseline, 3 months, 12 months
|
12 item investigator developed measure based on the Expert Consensus for Local Implementation of Physical Activity Policy, Systems and Environment (ECLIPPSE) strategies, specifically focusing on action domains.
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Baseline, 3 months, 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Collective Efficacy
Periodo de tiempo: Baseline, 3 months, 12 months
|
5 item investigator developed survey to assess perceived collective efficacy for making built environment changes
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Baseline, 3 months, 12 months
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Collective Behavioral Capability
Periodo de tiempo: Baseline, 3 months, 12 months
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3-item investigator developed survey assessing perceived collective behavioral capability for built environment change
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Baseline, 3 months, 12 months
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Perceived Impact of Built Environment Change
Periodo de tiempo: Baseline, 3 months, 12 months
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12 item investigator developed survey of the perceived impact of built environment changes
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Baseline, 3 months, 12 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Implementation of Built Environment Changes
Periodo de tiempo: Baseline, 3 months, 6 months
|
Exploratory 9 items survey developed by the investigator team to assess completion of built environment changes.
Considered an exploratory outcome because the funded study time frame precludes ability to comprehensively monitor changes over time, as built environment changes can require many years to complete.
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Baseline, 3 months, 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Stephenie C Lemon, PhD, MS, University of Massachusetts, Worcester
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de febrero de 2026
Finalización primaria (Estimado)
1 de septiembre de 2028
Finalización del estudio (Estimado)
1 de septiembre de 2029
Fechas de registro del estudio
Enviado por primera vez
14 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de agosto de 2026
Publicado por primera vez (Actual)
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de agosto de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- STUDY00002008
- U48DP006808 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Per our Data Management Plan with the funder (CDC), data may be shared with investigators wishing to perform secondary analyses.
Only de-identified data conducted in compliance with IRB regulations and the Data Management Plan will be shared upon request and with a data use agreement.
Marco de tiempo para compartir IPD
Data will be made available beginning 12 months after completion of the study and available for 5 years.
Criterios de acceso compartido de IPD
Deidentified individual participant data will be made available to qualified researchers whose proposed use has been approved by the study investigators.
Requests must include a methodologically sound research proposal.
Investigators will be required to sign a Data Use Agreement.
Requests must be made to the PI.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .