Child Friendly Menu Labelling and Food Choices (MealTrain)

November 13, 2017 updated by: Jill Hamilton, The Hospital for Sick Children

A Randomized Controlled Trial to Evaluate the Impact of Child Friendly Menu Labelling Designs on Food Choices by Parents and Children in an Inpatient Hospital Setting

Childhood obesity is a major problem in Canada. Children are eating larger portions and have easier access to high-fat, high-sugar foods and drinks. Menu labelling is a promising tool to teach families about healthier choices. The investigators will study the impact of combining child-friendly superhero food labels, fun food names, and a traffic light system on the food choices of children and their parents at SickKids. The investigators will use the hospital inpatient food ordering system (Meal Train) and look at food orders and eating patterns before and after introduction of the revised Meal Train menu. Only the design format of the menu was changed and all menu items remained unchanged. The investigators will also survey the families on their thoughts about the menu. This study will help doctors and dietitians develop strategies to deliver nutrition education to families.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Childhood obesity is recognized as a major public health epidemic in Canada with over 31.5% of all 5- to 17-year-olds being overweight or obese. The etiology of this increase in childhood obesity can be attributed to trends in children's diets that include increasing access to foods high in fats, added sugars, and eating outside the home with routine exposure to large portions of energy-dense, nutrient-poor foods. Menu labelling and point-of-purchase nutrition information is a promising potential cost effective public health strategy and utilized in the adult population. In this study, the investigators plan to evaluate the impact of a combination of labelling techniques including attractive characters, descriptive food names and traffic light system on food choices made by children and their parents in an inpatient hospital setting at the Hospital for Sick Children. The investigators will assess patient ordering and consumption patterns before and after the introduction of a revised educational Meal Train menu. A crossover randomized control trial design will be employed to identify changes in fruit and vegetable intake, healthy ("green light") option intake, number of sweetened beverages and energy-dense nutrient-poor ("red light") foods chosen as well as the number of children that meet the Canadian Food Guide (CFG) daily serving recommendations. As a secondary analysis, the investigators will be collecting participant's age, sex and weight-for-age z-score (as defined by the World Health Organization guidelines) to investigate any potential relationships between these variables and food ordering patterns before and after introduction of the proposed educational menu. A questionnaire will also be distributed to assess parent and child perceptions of the revised Meal Train menu. The investigators hypothesize patient ordering and consumption patterns before and after the introduction of a revised educational Meal Train menu will promote healthier food selections. While this type of intervention has been studied in hypothetical restaurants and cafeteria setting, this will be the first study conducted in a hospital setting with pediatric inpatients and their parents.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
163

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5V1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admitted to a general pediatrics or subspecialty wards
  • Fluent in written English

Exclusion Criteria:

  • NPO or receiving parenteral nutrition at any point in their admission
  • Specialized diet e.g. celiac, purée, renal diet, or high energy diet
  • Those exposed to educational intervention menu in first 2 weeks who remain on ward following the crossover period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Current MealTrain menu
This is the current menu being employed for food ordering in the pediatric inpatient wards.
Experimental: Intervention MealTrain menu
The intervention menu included child-friendly labeling (attractive characters, fun food names and traffic light system) to encourage healthier choices.
Other: Intervention MealTrain menu
Nutrition education was incorporated using an interpretive traffic light system menu labeling. Dietitians categorized current menu items as green, yellow and red based on fiber, added sugar, saturated fats, and sodium content. A section entitled "Eat like a superhero" was created to prime children to consider what their potential role models choose, and incorporates descriptive names, suggest sample breakfast, lunch and dinner meals with photographs of portion sizes. Original cartoon female grapes and male broccoli superhero characters were created to employ promotional techniques specifically to promote fruits and vegetable selection for boys and girls.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate patient ordering patterns before and after the introduction of the revised educational Meal Train menu.
Time Frame: 1 month

Specifically, the investigators will determine whether the revised Meal Train menu results in:

  1. Increased fruit and vegetable ordered
  2. A decrease in the number of sweetened beverages and energy-dense nutrient-poor ("red light") foods ordered
  3. A higher number of individual daily food orders that meet the Canadian Food Guide (CFG) daily serving recommendations.
  4. An increase in healthy foods ordered (green light options)
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relationship between patient demographics and meal orders
Time Frame: 1 month
The relationship between age, sex and weight-for-age z-score (as defined by the World Health Organization guidelines) and food ordering/consumption patterns before and after introduction of the proposed educational menu
1 month
Impact of child-friendly menu designs on food orders
Time Frame: 1 month
Foods highlighted by specific aspects of the menu (attractive characters and descriptive food names OR traffic light system) and whether their presence impacted food ordering patterns.
1 month
Evaluation of meal consumption
Time Frame: 1 month

Meal consumption: Meal trays of 20% of orders ( 2 days/study period) will be collected and leftover food measured by volunteer dietetic interns.

Consumption patterns will be evaluated before and after the introduction of the revised educational Meal Train menu. Specifically, we will determine whether the revised Meal Train menu results in:

Specifically, we will determine whether the revised Meal Train menu results in:

  1. Increased fruit and vegetable consumed
  2. A decrease in the number of sweetened beverages and energy-dense nutrient-poor ("red light") foods consumed
  3. A higher number of individual daily food consumption that meet the Canadian Food Guide (CFG) daily serving recommendations.
  4. An increase in healthy foods consumed (green light options)
1 month
Parent/child perceptions of the revised Meal Train menu
Time Frame: 1 month
Survey: a one page paper survey for both parent and child (age > 10) to assess perceptions of menu labelling on food ordering
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jill Hamilton, MD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000048168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators plan to publish in a peer reviewed journal, as well as presnt at national and international conferences (Canadian Pediatric Endocrine Group, International Conference for Obesity and Canadian Pediatric Society )

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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