- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07780825
Neighborhood Connect
18. august 2026 oppdatert 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
240
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Stephenie C Lemon, PhD, MS
- Telefonnummer: 15088564098
- E-post: Stephenie.Lemon@Umassmed.edu
Studiesteder
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Massachusetts
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Worcester, Massachusetts, Forente stater, 01655
- Rekruttering
- University of Massachusetts Chan Medical School
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Ta kontakt med:
- Stephenie C Lemon, PhD, MS
- Telefonnummer: 5088261325
- E-post: Stephenie.Lemon@Umassmed.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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Annen: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Built environment actions
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Collective Efficacy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Implementation of Built Environment Changes
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Stephenie C Lemon, PhD, MS, University of Massachusetts, Worcester
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2026
Primær fullføring (Antatt)
1. september 2028
Studiet fullført (Antatt)
1. september 2029
Datoer for studieregistrering
Først innsendt
14. august 2026
Først innsendt som oppfylte QC-kriteriene
18. august 2026
Først lagt ut (Faktiske)
24. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. august 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- STUDY00002008
- U48DP006808 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
Data will be made available beginning 12 months after completion of the study and available for 5 years.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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