- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07780825
Neighborhood Connect
18 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
240
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Stephenie C Lemon, PhD, MS
- Numéro de téléphone: 15088564098
- E-mail: Stephenie.Lemon@Umassmed.edu
Lieux d'étude
-
-
Massachusetts
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Worcester, Massachusetts, États-Unis, 01655
- Recrutement
- University of Massachusetts Chan Medical School
-
Contact:
- Stephenie C Lemon, PhD, MS
- Numéro de téléphone: 5088261325
- E-mail: Stephenie.Lemon@Umassmed.edu
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Autre: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Built environment actions
Délai: 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.
|
Baseline, 3 months, 12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Collective Efficacy
Délai: 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
|
|
Collective Behavioral Capability
Délai: Baseline, 3 months, 12 months
|
3-item investigator developed survey assessing perceived collective behavioral capability for built environment change
|
Baseline, 3 months, 12 months
|
|
Perceived Impact of Built Environment Change
Délai: Baseline, 3 months, 12 months
|
12 item investigator developed survey of the perceived impact of built environment changes
|
Baseline, 3 months, 12 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Implementation of Built Environment Changes
Délai: 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.
|
Baseline, 3 months, 6 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Stephenie C Lemon, PhD, MS, University of Massachusetts, Worcester
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 février 2026
Achèvement primaire (Estimé)
1 septembre 2028
Achèvement de l'étude (Estimé)
1 septembre 2029
Dates d'inscription aux études
Première soumission
14 août 2026
Première soumission répondant aux critères de contrôle qualité
18 août 2026
Première publication (Réel)
24 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 août 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- STUDY00002008
- U48DP006808 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage IPD
Data will be made available beginning 12 months after completion of the study and available for 5 years.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .