- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07780825
Neighborhood Connect
18 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
240
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Stephenie C Lemon, PhD, MS
- Numero di telefono: 15088564098
- Email: Stephenie.Lemon@Umassmed.edu
Luoghi di studio
-
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Massachusetts
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Worcester, Massachusetts, Stati Uniti, 01655
- Reclutamento
- University of Massachusetts Chan Medical School
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Contatto:
- Stephenie C Lemon, PhD, MS
- Numero di telefono: 5088261325
- Email: Stephenie.Lemon@Umassmed.edu
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
|
|
Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Built environment actions
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Collective Efficacy
Lasso di tempo: Baseline, 3 months, 12 months
|
5 item investigator developed survey to assess perceived collective efficacy for making built environment changes
|
Baseline, 3 months, 12 months
|
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Collective Behavioral Capability
Lasso di tempo: Baseline, 3 months, 12 months
|
3-item investigator developed survey assessing perceived collective behavioral capability for built environment change
|
Baseline, 3 months, 12 months
|
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Perceived Impact of Built Environment Change
Lasso di tempo: Baseline, 3 months, 12 months
|
12 item investigator developed survey of the perceived impact of built environment changes
|
Baseline, 3 months, 12 months
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Implementation of Built Environment Changes
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Stephenie C Lemon, PhD, MS, University of Massachusetts, Worcester
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 febbraio 2026
Completamento primario (Stimato)
1 settembre 2028
Completamento dello studio (Stimato)
1 settembre 2029
Date di iscrizione allo studio
Primo inviato
14 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
18 agosto 2026
Primo Inserito (Effettivo)
24 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 agosto 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- STUDY00002008
- U48DP006808 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Periodo di condivisione IPD
Data will be made available beginning 12 months after completion of the study and available for 5 years.
Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .