Evaluating a Healthy Restaurant Kids Meals Policy

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

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

    • Minnesota
      • Minneapolis, Minnesota, United States, 55454-1087
        • University of Minnesota
    • North Carolina
      • Research Triangle Park, North Carolina, United States, 27709
        • RTI, International
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

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
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.
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:
  • Healthy Restaurant Kids' Meals Policy
  • Healthy Default Beverage Policy
  • Healthy Default Beverage Law
  • Healthy-by-Default Policy
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.

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
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
24 months
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
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.
24 months
Change from baseline total caloric intake during the restaurant meal at 24 months
Time Frame: 24 months
Total calories consumed by the child during the restaurant eating occasion
24 months
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
Change from baseline calories consumed from healthy beverages during the restaurant meal at 24 months
Time Frame: 24 months
Calories consumed by the child from healthy beverages as defined by NYC/Philadelphia law during the restaurant eating occasion
24 months
Change from baseline calories consumed from other unhealthy beverages during the restaurant meal 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, during the restaurant eating occasion
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
Fluid ounces of sugar-sweetened beverages purchased for the child at the restaurant
24 months
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
24 months
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
24 months
Change from baseline frequency of dining at fast food restaurants at 24 months
Time Frame: 24 months
Number of lunch or dinner meals from fast food restaurants for the child in the past week
24 months

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.

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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