Childhood ObesityMealTrainNCT02692001
Child Friendly Menu Labelling and Food Choices
A study testing Intervention MealTrain menu in people with Childhood Obesity, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Intervention MealTrain menu
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Admitted to a general pediatrics or subspecialty wards
- Fluent in written English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Obesity
- Being tested
- Intervention MealTrain menu
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention MealTrain menuOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Current MealTrain menu | No intervention | This is the current menu being employed for food ordering in the pediatric inpatient wards. |
| Intervention MealTrain menu | Experimental | The intervention menu included child-friendly labeling (attractive characters, fun food names and traffic light system) to encourage healthier choices. Receives: Other: Intervention MealTrain menu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate patient ordering patterns before and after the introduction of the revised educational Meal Train menu.
Specifically, the investigators will determine whether the revised Meal Train menu results in:
- Increased fruit and vegetable ordered
- A decrease in the number of sweetened beverages and energy-dense nutrient-poor ("red light") foods ordered
- A higher number of individual daily food orders that meet the Canadian Food Guide (CFG) daily serving recommendations.
- An increase in healthy foods ordered (green light options)
Measured: 1 month
Secondary outcomes (4)
Relationship between patient demographics and meal orders
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
Measured: 1 month
Impact of child-friendly menu designs on food orders
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.
Measured: 1 month
Evaluation of meal consumption
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:
- Increased fruit and vegetable consumed
- A decrease in the number of sweetened beverages and energy-dense nutrient-poor ("red light") foods consumed
- A higher number of individual daily food consumption that meet the Canadian Food Guide (CFG) daily serving recommendations.
- An increase in healthy foods consumed (green light options)
Measured: 1 month
Parent/child perceptions of the revised Meal Train menu
Survey: a one page paper survey for both parent and child (age > 10) to assess perceptions of menu labelling on food ordering
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Hamilton, The Hospital for Sick Children
- Investigators
- Jill Hamilton, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692001
- Sponsor's protocol ID
- 1000048168
- Acronym
- MealTrain
- Status last verified
- Nov 2017
- First submitted
- 22 Feb 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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 )
Publications
Basak S, Steinberg A, Campbell A, Dupuis A, Chen S, Dayan AB, Dello S, Hamilton J. All Aboard Meal Train: Can Child-Friendly Menu Labeling Promote Healthier Choices in Hospitals? J Pediatr. 2019 Jan;204:59-65.e3. doi: 10.1016/j.jpeds.2018.08.073. Epub 2018 Sep 28.
PubMed 30274925
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02692001
- Acronym / sponsor ID
- MealTrain / 1000048168
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current MealTrain menu | No intervention | –This is the current menu being employed for food ordering in the pediatric inpatient wards. |
| Intervention MealTrain menu | Experimental | Other: Intervention MealTrain menuThe intervention menu included child-friendly labeling (attractive characters, fun food names and traffic light system) to encourage healthier choices. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Admitted to a general pediatrics or subspecialty wards
- Fluent in written English
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention MealTrain menuNutrition 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. | Other | Intervention MealTrain menu |
Primary outcome
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)
4 secondary outcomes
Relationship between patient demographics and meal orders
Time frame: 1 month
Impact of child-friendly menu designs on food orders
Time frame: 1 month
Evaluation of meal consumption
Time frame: 1 month
Parent/child perceptions of the revised Meal Train menu
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 30274925Basak S, Steinberg A, Campbell A, Dupuis A, Chen S, Dayan AB, Dello S, Hamilton J. All Aboard Meal Train: Can Child-Friendly Menu Labeling Promote Healthier Choices in Hospitals? J Pediatr. 2019 Jan;204:59-65.e3. doi: 10.1016/j.jpeds.2018.08.073. Epub 2018 Sep 28.
- Individual participant dataSharing planned: Yes. 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 )
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Hamilton, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention MealTrain menu in people with Childhood Obesity, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate patient ordering patterns before and after the introduction of the revised educational Meal Train menu. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02692001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.