NCT02511938

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

July 21, 2015

Last Update Submit

April 24, 2017

Conditions

Keywords

childhood obesityrestaurantaway from home foods

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Customer observations/interviews

    every other week throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix)

Study Arms (2)

Menu Only intervention

EXPERIMENTAL

Restaurants will receive a new healthy kids' menu

Other: Menu Only

Menu Plus Intervention

EXPERIMENTAL

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.

Other: Menu Plus intervention

Interventions

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 Only 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.

Menu Plus Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Party does not speak English and/or Spanish
  • Parties larger than six people
  • For restaurant manager interviews:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SDSU Research Foundation

San Diego, California, 92182, United States

Location

Related Publications (1)

  • Ayala GX, Castro IA, Pickrel JL, Williams CB, Lin SF, Madanat H, Jun HJ, Zive M. A restaurant-based intervention to promote sales of healthy children's menu items: the Kids' Choice Restaurant Program cluster randomized trial. BMC Public Health. 2016 Mar 10;16:250. doi: 10.1186/s12889-016-2892-5.

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Guadalupe X Ayala, PhD, MPH

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 30, 2015

Study Start

December 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations