- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04330235
Evaluating a Healthy Restaurant Kids Meals Policy
September 26, 2022 updated by: Johns Hopkins Bloomberg School of Public Health
More than a dozen municipalities have passed healthy default kids' beverage policies.
These policies seek to reduce child consumption of sugar-sweetened beverages (SSBs) by requiring that restaurants serve only healthy beverages (e.g., water, milk, or 100% juice) instead of SSBs as the default choice with children's meals in restaurants.
These policies have potential to meaningfully reduce child SSB consumption.
However, there are significant gaps in our knowledge of the effects of healthy default beverage policies on children's health.
This study uses a natural experiment to evaluate the effects of a healthy default beverage policy in two U.S. cities, New York City and Philadelphia, on children's fast-food restaurant meal orders and dietary intake.
The primary hypothesis is that the policy will reduce children's SSB purchases and consumption, reduce children's total caloric intake, and improve diet quality at the fast-food restaurant meal and on the day of the restaurant meal.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study uses a quasi-experimental approach to evaluate the effects of a healthy default kids' beverage policy on children's fast-food restaurant meal purchases and dietary intake.
Annotated receipt and survey data will be collected from parents purchasing a food or beverage for a child 2-10 years of age at fast-food restaurants.
Eligible participants will be asked to participate in a telephone dietary recall the following day.
Data will be collected from a repeated cross-section of children in two intervention cities implementing a healthy default kids' beverage policy (New York City and Philadelphia) and a control area not implementing the policy (northern New Jersey) before the policy is implemented and after the policy goes into effect.
A difference-in-differences analytic approach will be used to compare the change in children's fast-food restaurant meal orders and dietary intake pre- to post-implementation in the intervention versus control groups.
A Holm-Bonferroni correction for multiple comparisons will be applied to p-values for secondary outcomes.
Study Type
Observational
Enrollment (Actual)
3480
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
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Minnesota
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Minneapolis, Minnesota, United States, 55454-1087
- University of Minnesota
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North Carolina
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Research Triangle Park, North Carolina, United States, 27709
- RTI, International
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Parents/legal guardians of children 2-10 years of age will be recruited from fast-food restaurants in Philadelphia, northern New Jersey, and New York City that operate more than one location in both the intervention and control areas, serve kids' meals, and are not compliant with the healthy default kids' beverage policy at baseline.
Description
Inclusion Criteria:
- Adult 18 years of age or older
- Parent or legal guardian of a child 2-10 years of age
- Purchasing at least one food or beverage item for the child at the restaurant (if purchasing foods or beverages for multiple children, only items purchased for the youngest child 2-10 years of age will be included)
- Able to speak and understand English or Spanish
Additional criteria for dietary recalls:
- Parent or legal guardian 18 years of age or older is present for the recall
- If child for whom the restaurant meal was purchased is 6 years of age or older, child is present for the recall
- If child for whom the restaurant meal was purchased is 9 years of age or older, the child is present for the recall and is able to speak and understand English or Spanish
Exclusion Criteria:
- Younger than 18 years of age
- Is not a parent or legal guardian to a child 2-10 years of age
- Is not purchasing one or more food or beverage items for the child at the restaurant
- Does not speak or understand English or Spanish
Additional criteria for dietary recalls:
- Parent or legal guardian is not present for the recall
- The restaurant meal was purchased for a child 6 years of age or older, who is not present for the recall
- Child 9 years of age or older, for whom the restaurant meal was purchased, is not able to speak or understand English or Spanish
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Intervention Group
Children 2-10 years of age dining at fast-food restaurants in New York City and Philadelphia, where a healthy default beverage policy will be enacted.
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The healthy default kids' beverage policy requires that all restaurants serve only healthy beverages (water, milk, or 100% juice) instead of sugary beverages as the default beverage with children's meals.
The policy has been enacted in New York City and Philadelphia and will go into effect in April 2020.
Other Names:
|
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Control Group
Children 2-10 years of age dining at fast-food restaurants in northern New Jersey, where a healthy default beverage policy will not be enacted.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline total caloric intake at 24 months
Time Frame: 24 months
|
Total calories consumed by the child on the day of the restaurant meal
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24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline calories consumed from sugar-sweetened beverages at 24 months
Time Frame: 24 months
|
Calories consumed by the child from sugar-sweetened beverages on the day of the restaurant meal
|
24 months
|
|
Change from baseline calories consumed from healthy beverages at 24 months
Time Frame: 24 months
|
Calories consumed by the child from healthy beverages as defined by NYC/Philadelphia law on the day of the restaurant meal
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24 months
|
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Change from baseline calories consumed from other unhealthy beverages at 24 months
Time Frame: 24 months
|
Calories consumed by the child from unhealthy beverages as defined by NYC/Philadelphia law, excluding sugar-sweetened beverages, on the day of the restaurant meal
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24 months
|
|
Change from baseline Healthy Eating Index 2015 score at 24 months
Time Frame: 24 months
|
Child's diet quality, measured using the Healthy Eating Index 2015, on the day of the restaurant meal.
The Healthy Eating Index 2015 measures how well a diet aligns with the Dietary Guidelines for Americans.
It is measured on a scale from 0-100, where higher scores indicate a healthier diet.
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24 months
|
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Change from baseline total caloric intake during the restaurant meal at 24 months
Time Frame: 24 months
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Total calories consumed by the child during the restaurant eating occasion
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24 months
|
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Change from baseline calories consumed from sugar-sweetened beverages during the restaurant meal at 24 months
Time Frame: 24 months
|
Calories consumed by the child from sugar-sweetened beverages during the restaurant eating occasion
|
24 months
|
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Change from baseline calories consumed from healthy beverages during the restaurant meal at 24 months
Time Frame: 24 months
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Calories consumed by the child from healthy beverages as defined by NYC/Philadelphia law during the restaurant eating occasion
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24 months
|
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Change from baseline calories consumed from other unhealthy beverages during the restaurant meal at 24 months
Time Frame: 24 months
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Calories consumed by the child from unhealthy beverages as defined by NYC/Philadelphia law, excluding sugar-sweetened beverages, during the restaurant eating occasion
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24 months
|
|
Change from baseline Healthy Eating Index 2015 score during the restaurant meal at 24 months
Time Frame: 24 months
|
Child's diet quality, measured using the Healthy Eating Index 2015, during the restaurant eating occasion.
The Healthy Eating Index 2015 measures how well a diet aligns with the Dietary Guidelines for Americans.
It is measured on a scale from 0-100, where higher scores indicate a healthier diet.
|
24 months
|
|
Change from baseline fluid ounces of sugar-sweetened beverages purchased at 24 months
Time Frame: 24 months
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Fluid ounces of sugar-sweetened beverages purchased for the child at the restaurant
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24 months
|
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Change from baseline fluid ounces of healthy beverages purchased at 24 months
Time Frame: 24 months
|
Fluid ounces of healthy beverages as defined by NYC/Philadelphia law purchased for the child at the restaurant
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24 months
|
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Change from baseline fluid ounces of other unhealthy beverages purchased at 24 months
Time Frame: 24 months
|
Fluid ounces of unhealthy beverages as defined by NYC/Philadelphia law, excluding sugar-sweetened beverages, purchased for the child at the restaurant
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24 months
|
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Change from baseline frequency of dining at fast food restaurants at 24 months
Time Frame: 24 months
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Number of lunch or dinner meals from fast food restaurants for the child in the past week
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24 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline fluid ounces consumed from sugar-sweetened beverages at 24 months
Time Frame: 24 months
|
Fluid ounces consumed by the child from sugar-sweetened beverages on the day of the restaurant meal
|
24 months
|
|
Change from baseline fluid ounces consumed from healthy beverages at 24 months
Time Frame: 24 months
|
Fluid ounces consumed by the child from healthy beverages as defined by NYC/Philadelphia law on the day of the restaurant meal
|
24 months
|
|
Change from baseline fluid ounces consumed from other unhealthy beverages at 24 months
Time Frame: 24 months
|
Fluid ounces consumed by the child from unhealthy beverages as defined by NYC/Philadelphia law, excluding sugar-sweetened beverages, on the day of the restaurant meal
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Alyssa Moran, ScD, Johns Hopkins Bloomberg School of Public Health
- Principal Investigator: Angie Cradock, ScD, Harvard School of Public Health (HSPH)
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 (Actual)
October 13, 2019
Primary Completion (Actual)
July 18, 2022
Study Completion (Actual)
July 18, 2022
Study Registration Dates
First Submitted
January 16, 2020
First Submitted That Met QC Criteria
March 31, 2020
First Posted (Actual)
April 1, 2020
Study Record Updates
Last Update Posted (Actual)
September 28, 2022
Last Update Submitted That Met QC Criteria
September 26, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- HDB-NYC
- 1R01HD100983-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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