- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05869149
Systemvitenskapelige tilnærminger for å forbedre tilgangen til sunnere matvarer: The FRESH Trial (FRESH)
Working with independently owned restaurants, a common source of calorie-rich, nutrient-poor foods in predominantly minority, low-income urban neighborhoods, has the potential to improve dietary quality, and contribute to cancer prevention. This study uses systems science approaches to improve access to healthier foods in independently owned restaurants by: 1) testing the effects of a novel intervention called FRESH (Focus on Restaurant Engagement to Strengthen Health) on dietary quality, health indicators and other outcomes in African American and Latin communities, and 2) developing a system dynamics model to allow stakeholders to virtually test FRESH strategies in their own communities. The resulting restaurant intervention simulation model offers potential cost savings from avoided trial-and-error testing, and will support community-based cancer prevention.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Joel Gittlesohn, PhD
- Telefonnummer: (410)955-3927
- E-post: jgittel1@jhu.edu
Studiesteder
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-
Maryland
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Baltimore, Maryland, Forente stater, 21205
- Rekruttering
- Johns Hopkins Bloomberg School of Public Health
-
Ta kontakt med:
- Joel Gittelsohn, PhD
- E-post: jgittel1@jh.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Adult (18-75 years)
- Regular restaurant customer (e.g., visits the specified restaurant at least 1x/week)
- Live in a household of at least 2 persons (criterion intended to provide a more stable sample, and to reduce loss to follow-up)
- Current resident of study neighborhood
Exclusion Criteria:
- Anticipate moving out of Baltimore or District of Columbia metropolitan area in the next 18 months
- Pregnant (due to changes in diet, weight and body composition)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Restaurants receiving FRESH intervention
Restaurants enrolled in the experimental arm of will FRESH undergo activities aimed to improve their healthy food offerings at their restaurants. |
FRESH is a restaurant-based intervention in low-income neighborhoods in Baltimore, MD and the Washington, District of Columbia metro area that aims to improve the healthy prepared-food environment for consumers, informed by community members and other stakeholders. FRESH intervention components include food preparation, food access and procurement, and consumer nutrition environment. Activities will take place over 16 months, and include training restaurant chefs to use healthier cooking methods, partnering with restaurant suppliers to offer healthier ingredients, and offering point-of-purchase promotions to educate customers on the healthier promoted food options. Intervention staff will form strong relationships with restaurant owners and chefs via in-person visits at least twice a month. Data from the intervention trial will inform the development of a system dynamics simulation model that will allow stakeholders to test new policy ideas prior to implementation. |
|
Ingen inngripen: Restaurants not receiving FRESH intervention
Restaurants will be enrolled in the study, but not receive the FRESH intervention. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Customer Dietary Quality
Tidsramme: 1 hour, 24 months apart
|
Regular customer diet quality in the last 30 days will be assessed using the 2014 semi-quantitative Block Food Frequency Questionnaire (FFQ). The FFQ provides the data that allows for calculating the Healthy Eating Index. We will use the 2015 index rules. Healthy Eating Index (HEI) 2015 Score and individual component scores will be calculated from the FFQ according to the HEI-2015 guidelines to assess changes in overall diet quality and changes within each component. The range of scores for the Healthy Eating Index 2015 is 0-100. A higher score is considered better and represents meeting more of the recommended dietary guidelines. |
1 hour, 24 months apart
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Joel Gittlesohn, PhD, Johns Hopkins Bloomberg School of Public Health
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 5R01MD018022-02 (U.S. NIH-stipend/kontrakt)
- IRB00024491 (Annen identifikator: JHSPH IRB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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