- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02511938
Kids' Choice Restaurant Program (KCRP)
24. april 2017 oppdatert av: Guadalupe X. Ayala, San Diego State University
Introducing Child Menus in Restaurants to Improve Access to Healthier Foods
This study will introduce healthy child menu items into 8 independent full service restaurants in San Diego County.
The restaurants will be assigned either to receive new, healthy kids' menu items or to receive the new menu items in addition to marketing materials and staff trainings to support promotion of these new menu items.
The primary outcome for the study is sales of kids' menu items.
Additional customer observation and interview data will be collected, as well as manager interviews and restaurant environment assessments.
Process evaluation measures will also evaluate the implementation of the intervention.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The purpose of the study is to assess the efficacy of an intervention to improve access to healthier foods by introducing or changing child menus in restaurants.
We propose recruiting 8 independent full service restaurants, either with or without existing child menus.
Recruitment will occur in waves of two restaurants per wave for a total of four waves.
Restaurants will be matched on key criteria such as whether they have a child menu and restaurant size based on seating (categorized as small -to- medium or large).
Matched restaurants will be randomized to either an 8--week menu--only intervention or a menu--plus intervention that will occur at the same time.
The menu--only intervention will involve working with the restaurant to add new healthy child menu items to their menus.
The menu--plus intervention will involve working with the restaurants to add new healthy child menu items tailored to their menus, along with promotional materials and restaurant employee trainings to encourage customers to select these menu items.
Weekly detailed sales data (reported by menu item) at baseline for one month, ongoing in all restaurants during 8-week intervention, and for one month at post intervention for all restaurants will be gathered and serve as the primary outcome of interest.
Additionally, biweekly observations and customer interviews in each restaurant during one month pre--intervention phase, over 8--week intervention period, and during one month post-intervention phase to capture how orders are placed and what is ordered and reported to be consumed by the child.
We will also assess the feasibility and fidelity of the intervention using manager interview data (baseline and post--intervention), restaurants audits (baseline, once during the intervention, and at post--intervention), and process evaluation measures (weekly during 8-week intervention).
The study is not designed to provide a direct benefit to the participants and no such benefits can be guaranteed; however, participants may learn more about current public health research and efforts to understand child ordering and consumption behaviors in restaurants.
This study may benefit independent restaurants as the findings will contribute to designing evidence--based approaches to improving the nutritional quality of child menu offerings and will help researchers to understand ordering and consumption behaviors for children in restaurants.
This study presents minimal risks to the participants.
Studietype
Intervensjonell
Registrering (Faktiske)
106
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
San Diego, California, Forente stater, 92182
- SDSU Research Foundation
-
-
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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
For customer observations and interviews:
Inclusion Criteria:
- Restaurant dining parties having at least one adult 18 or older and one child in party who appears to be between the ages of 3--17 years
- Dining parties including no more than six people
- Party speaks English and/or Spanish
Exclusion Criteria:
- Party does not speak English and/or Spanish
- Parties larger than six people
For restaurant manager interviews:
Inclusion Criteria:
- At least 18 years of age
- Has worked at restaurant at least 4 months
- Works at least 20 hours per week for the restaurant
- Plans to continue working at the restaurant for at least 6 months
- Speaks and writes English and/or Spanish
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Menu Only intervention
Restaurants will receive a new healthy kids' menu
|
Restaurants will collaborate with project to develop and introduce new healthy kid's menu items.
Project will provide recipes, preparation support, nutritional information, and printed menus to restaurants.
|
|
Eksperimentell: Menu Plus Intervention
Restaurants will receive a new healthy kids' menu, supporting marketing materials, and brief trainings for customer service staff and kitchen staff to support and promote the new menu items.
|
Restaurants will collaborate with project to develop and introduce new healthy kid's menu items.
Project will provide recipes, preparation support, nutritional information, and printed menus to restaurants.
In addition, project will provide promotional materials and brief restaurant staff trainings to promote the new menu.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sales ($) of kids' menu items
Tidsramme: weekly throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix)
|
Change in weekly sales ($) of kids' menu items as a proportion of total restaurant sales between baseline, intervention period, and post-intervention
|
weekly throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Customer observations/interviews
Tidsramme: every other week throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix)
|
change in child customer ordering behavior, decision making, and consumption between baseline, intervention period, and post-intervention
|
every other week throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Guadalupe X Ayala, PhD, MPH, San Diego State University
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
1. desember 2013
Primær fullføring (Faktiske)
1. november 2015
Studiet fullført (Faktiske)
1. november 2015
Datoer for studieregistrering
Først innsendt
21. juli 2015
Først innsendt som oppfylte QC-kriteriene
29. juli 2015
Først lagt ut (Anslag)
30. juli 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. april 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. april 2017
Sist bekreftet
1. april 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R21HD071324 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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