NCT04330235

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

2.8 years

First QC Date

January 16, 2020

Last Update Submit

September 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline total caloric intake at 24 months

    Total calories consumed by the child on the day of the restaurant meal

    24 months

Secondary Outcomes (13)

  • Change from baseline calories consumed from sugar-sweetened beverages at 24 months

    24 months

  • Change from baseline calories consumed from healthy beverages at 24 months

    24 months

  • Change from baseline calories consumed from other unhealthy beverages at 24 months

    24 months

  • Change from baseline Healthy Eating Index 2015 score at 24 months

    24 months

  • Change from baseline total caloric intake during the restaurant meal at 24 months

    24 months

  • +8 more secondary outcomes

Other Outcomes (3)

  • Change from baseline fluid ounces consumed from sugar-sweetened beverages at 24 months

    24 months

  • Change from baseline fluid ounces consumed from healthy beverages at 24 months

    24 months

  • Change from baseline fluid ounces consumed from other unhealthy beverages at 24 months

    24 months

Study Arms (2)

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

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.

Interventions

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.

Also known as: Healthy Restaurant Kids' Meals Policy, Healthy Default Beverage Policy, Healthy Default Beverage Law, Healthy-by-Default Policy
Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Minnesota

Minneapolis, Minnesota, 55454-1087, United States

Location

RTI, International

Research Triangle Park, North Carolina, 27709, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Alyssa Moran, ScD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR
  • Angie Cradock, ScD

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2020

First Posted

April 1, 2020

Study Start

October 13, 2019

Primary Completion

July 18, 2022

Study Completion

July 18, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Locations