- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02511938
Kids' Choice Restaurant Program (KCRP)
24 avril 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
106
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.
Lieux d'étude
-
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California
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San Diego, California, États-Unis, 92182
- SDSU Research Foundation
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-
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
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
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: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sales ($) of kids' menu items
Délai: weekly throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix)
|
Change in weekly sales ($) 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)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Customer observations/interviews
Délai: every other week throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix)
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change in child customer ordering behavior, decision making, and consumption between baseline, intervention period, and post-intervention
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every other week throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Guadalupe X Ayala, PhD, MPH, San Diego State University
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
1 décembre 2013
Achèvement primaire (Réel)
1 novembre 2015
Achèvement de l'étude (Réel)
1 novembre 2015
Dates d'inscription aux études
Première soumission
21 juillet 2015
Première soumission répondant aux critères de contrôle qualité
29 juillet 2015
Première publication (Estimation)
30 juillet 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 avril 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 avril 2017
Dernière vérification
1 avril 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R21HD071324 (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) ?
INDÉCIS
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 .