- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07780825
Neighborhood Connect
18 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
240
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Stephenie C Lemon, PhD, MS
- Telefonnummer: 15088564098
- E-post: Stephenie.Lemon@Umassmed.edu
Studieorter
-
-
Massachusetts
-
Worcester, Massachusetts, Förenta staterna, 01655
- Rekrytering
- University of Massachusetts Chan Medical School
-
Kontakt:
- Stephenie C Lemon, PhD, MS
- Telefonnummer: 5088261325
- E-post: Stephenie.Lemon@Umassmed.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Övrig: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Built environment actions
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Collective Efficacy
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, 3 months, 12 months
|
12 item investigator developed survey of the perceived impact of built environment changes
|
Baseline, 3 months, 12 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Implementation of Built Environment Changes
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Stephenie C Lemon, PhD, MS, University of Massachusetts, Worcester
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2026
Primärt slutförande (Beräknad)
1 september 2028
Avslutad studie (Beräknad)
1 september 2029
Studieregistreringsdatum
Först inskickad
14 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
18 augusti 2026
Första postat (Faktisk)
24 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 augusti 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- STUDY00002008
- U48DP006808 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
Data will be made available beginning 12 months after completion of the study and available for 5 years.
Kriterier för IPD Sharing Access
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.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .