Clinical trial NCT04330235: Evaluating a Healthy Restaurant Kids Meals Policy
Official title: Evaluating a Healthy Restaurant Kids Meals Policy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet Habit
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
name: University of Pennsylvania
name: Harvard Pilgrim Health Care
name: University of Minnesota
name: RTI International
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-04-01
Enrollment: 3480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline total caloric intake at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Change from baseline calories consumed from sugar-sweetened beverages at 24 months
timeFrame: 24 months
measure: Change from baseline calories consumed from healthy beverages at 24 months
timeFrame: 24 months
measure: Change from baseline calories consumed from other unhealthy beverages at 24 months
timeFrame: 24 months
measure: Change from baseline Healthy Eating Index 2015 score at 24 months
timeFrame: 24 months
measure: Change from baseline total caloric intake during the restaurant meal at 24 months
timeFrame: 24 months
measure: Change from baseline calories consumed from sugar-sweetened beverages during the restaurant meal at 24 months
timeFrame: 24 months
measure: Change from baseline calories consumed from healthy beverages during the restaurant meal at 24 months
timeFrame: 24 months
measure: Change from baseline calories consumed from other unhealthy beverages during the restaurant meal at 24 months
timeFrame: 24 months
measure: Change from baseline Healthy Eating Index 2015 score during the restaurant meal at 24 months
timeFrame: 24 months
measure: Change from baseline fluid ounces of sugar-sweetened beverages purchased at 24 months
timeFrame: 24 months
measure: Change from baseline fluid ounces of healthy beverages purchased at 24 months
timeFrame: 24 months
measure: Change from baseline fluid ounces of other unhealthy beverages purchased at 24 months
timeFrame: 24 months
measure: Change from baseline frequency of dining at fast food restaurants at 24 months
timeFrame: 24 months
Other outcomes:
measure: Change from baseline fluid ounces consumed from sugar-sweetened beverages at 24 months
timeFrame: 24 months
measure: Change from baseline fluid ounces consumed from healthy beverages at 24 months
timeFrame: 24 months
measure: Change from baseline fluid ounces consumed from other unhealthy beverages at 24 months
timeFrame: 24 months
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Research Triangle Park
country: United States
facility: RTI, International
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Alyssa Moran, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Angie Cradock, ScD
role: PRINCIPAL_INVESTIGATOR
References: