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Evaluating a Healthy Restaurant Kids Meals Policy

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ClinicalTrials.gov Identifier: NCT04330235
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : September 21, 2021
Sponsor:
Collaborators:
Harvard School of Public Health (HSPH)
University of Pennsylvania
Harvard Pilgrim Health Care
University of Minnesota
RTI International
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief Summary:
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.

Condition or disease Intervention/treatment
Diet Habit Other: Healthy Default Kids' Beverage Policy

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluating a Healthy Restaurant Kids Meals Policy
Actual Study Start Date : October 13, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

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.
Other: Healthy Default Kids' Beverage Policy
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04330235


Contacts
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Contact: Alyssa Moran, ScD 410-614-0256 amoran10@jhu.edu

Locations
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United States, Minnesota
University of Minnesota Active, not recruiting
Minneapolis, Minnesota, United States, 55454-1087
United States, North Carolina
RTI, International Recruiting
Research Triangle Park, North Carolina, United States, 27709
Contact: Kristine Wiant, PhD    919-485-5531    fahrney@rti.org   
United States, Pennsylvania
University of Pennsylvania Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Harvard School of Public Health (HSPH)
University of Pennsylvania
Harvard Pilgrim Health Care
University of Minnesota
RTI International
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Alyssa Moran, ScD Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Angie Cradock, ScD Harvard School of Public Health (HSPH)
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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT04330235    
Other Study ID Numbers: HDB-NYC
1R01HD100983-01 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No