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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02511938
Other study ID # R21HD071324
Secondary ID
Status Completed
Phase N/A
First received July 21, 2015
Last updated April 24, 2017
Start date December 2013
Est. completion date November 2015

Study information

Verified date April 2017
Source San Diego State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Menu Only
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.
Menu Plus intervention
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.

Locations

Country Name City State
United States SDSU Research Foundation San Diego California

Sponsors (1)

Lead Sponsor Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sales ($) of kids' menu items Change in weekly sales ($) 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)
Secondary Customer observations/interviews 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)
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