Clinical trial NCT04334525: Promoting Healthier Eating Among Children in Restaurants
Official title: Promoting Healthier Eating Among Children in Restaurants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Keywords: child
restaurant
nudging
repeated exposure
diet
health
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-04-06
Enrollment: 241
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster-randomized design will be used. 6 locations of Anderson's, a regional quick-service restaurant in the Buffalo, New York, area will be paired based on income levels in the surrounding census tracts. A location from each pair will be randomized to each study group (intervention, control). Phased data collection will occur, with each pair of restaurants assigned to a cohort.
Primary purpose: PREVENTION

Brief summary: Restaurants are normative eating contexts for many families. Restaurant meals tend to be higher in calories and lower in nutritional quality than those prepared at home. Targeting children's food selection in restaurants has the potential to improve diet quality, attenuate excess energy intake, and shape healthy habits. The objective of this study is to make healthier kids' meal options more appealing and easier to choose via an in-restaurant intervention that combines repeated exposure and choice architecture strategies. Six locations of a quick-service restaurant will be paired based on income levels in the surrounding census tracts. A location from each pair will be randomized to each study group (intervention, control). Recruitment and data collection will be conducted across 3 cohorts, with recruitment conducted during a family's regular visit. Study participation will involve 7 more visits to the location where the family was recruited, 6 of which will be during an exposure period of about 2 months. Families in intervention restaurants will receive placemats promoting healthier featured kids' meals. Participating families will also receive a frequent diner card which, after purchasing one of the featured healthier kids' meals across 6 occasions, makes them eligible for a free kids' meal of their choice during a predetermined redemption period. In the control group, generic placemats will be provided, and participating families will be provided with frequent diner cards that can be used for any kids' meals. The aims of this study are: (1) to test effects of a healthier kids' meal intervention on children's meal orders, and (2) to test effects of a healthier kids' meal intervention on children's dietary intake. It is hypothesized that (1a) children in the intervention restaurants will be more likely than controls to select one of the promoted healthier kids' meals at post-test, (1b) children in the intervention group will order fewer calories and desserts and less saturated fat, sodium, and sugar at post-test versus controls, (1c) the promoted healthier meals will make up a greater percentage of kids' meals ordered in intervention restaurants versus controls, based on sales data across the study period, and (2) compared to controls, children in the intervention group will consume fewer calories and less saturated fat, sodium, and sugar in the restaurant at post-test.

Detailed description: Restaurants are normative eating contexts for many families. Restaurant meals tend to be higher in calories and lower in nutritional quality than those prepared at home. Targeting children's food selection in restaurants has the potential to improve diet quality, attenuate excess energy intake, and shape healthy habits. The objective of this study is to make healthier kids' meal options more appealing and easier to choose via an in-restaurant intervention that combines repeated exposure and choice architecture strategies.

Six locations of a quick-service restaurant will be paired based on income levels in the surrounding census tracts. A location from each pair will be randomized to each study group (intervention, control). Recruitment and data collection will be conducted across 3 cohorts. After recruitment, families will be asked to order and eat like they normally would. All participating families will then complete measures of children's orders, intake, and demographics. Then families will receive placemats and frequent diner cards. Families in intervention restaurants will receive placemats promoting healthier featured kids' meals. These families will also receive a frequent diner card, which after purchasing one of the featured healthier kids' meals across 6 occasions, makes them eligible for a free kids' meal of their choice during a predetermined redemption period. In the control group, generic placemats will be provided following baseline data collection, and families will also be provided with frequent diner cards that can be used for any kids' meals. During subsequent exposure periods, lasting about 2 months per cohort, families will return to the restaurant location where they were recruited on a weekly basis. Placemats will be available at the restaurant entrance, and corresponding signage will be displayed in the restaurant. In intervention restaurants, signs will advertise promoted meals and the option to select a toy in place of dessert. Participating children will be able to use their frequent diner card during this time to earn a free meal during the subsequent redemption period. Families will also be asked to complete a brief online survey once per week to monitor restaurant patronage. In each restaurant, study staff will conduct observations of a subsample of participating family and server interactions. Finally, post assessments will be completed during predetermined redemption periods, lasting about 3 months per cohort. Placemats and signage will still be available in restaurants during this time. Study staff will collect the frequent diner cards and ask families to order and eat like they normally would and to not throw out any food or leftovers. Families will be able to redeem any earned free kids' meals during this time. When the family is done eating, study staff will approach the table to administer study measures assessing orders, perspectives on the meal, and intake. Finally, families will also be prompted to complete an online dietary recall (ASA24) after their post assessment.

The specific aims of this study are: (1) to test effects of a healthier kids' meal intervention on children's meal orders, and (2) to test effects of a healthier kids' meal intervention on children's dietary intake. It is hypothesized that (1a) children in the intervention restaurants will be more likely than controls to select one of the promoted healthier kids' meals at post-test, (1b) children in the intervention group will order fewer calories and desserts and less saturated fat, sodium, and sugar at post-test versus controls, (1c) the promoted healthier meals will make up a greater percentage of kids' meals ordered in intervention restaurants versus controls, based on sales data across the study period, and (2) compared to controls, children in the intervention group will consume fewer calories and less saturated fat, sodium, and sugar in the restaurant at post-test.

Eligibility criteria: Inclusion Criteria:

* Fluent in English (parent/guardian \& child)
* 18 years or older (parent/ guardian)
* Between the ages of 4-8 years (child)
* Eats food from restaurants at least 2-3 times per month (child)
* Does not have allergies that preclude safe participation in the study (child)
* Eating a meal in the restaurant at the time of recruitment/baseline assessment
* Did not participate in pilot phase of this study, which involved taste tests of possible healthier meal options at the same restaurant chain

Exclusion Criteria:

* Is under 18 years of age (parent/ guardian)
* Does not have a child in the range of 4-8 years
* Does not speak English fluently (parent/guardian \& child)
* Does not eat food from a restaurant at least 2-3 times per month (child)
* Has food allergies that preclude safe participation in the study (child)
* Not eating a meal in the restaurant at recruitment/baseline
* Participated in pilot phase of this study, which involved taste tests of possible healthier meal options at the same restaurant chain

Primary outcomes:
measure: Meal type ordered for child in restaurant
timeFrame: Post-test (about 4 months after recruitment)
measure: Change in meal type ordered for child in restaurant
timeFrame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
measure: Total calories ordered for child in restaurant
timeFrame: Post-test (about 4 months after recruitment)
measure: Child in total calories ordered for child in restaurant
timeFrame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
measure: Total saturated fat ordered for child in restaurant
timeFrame: Post-test (about 4 months after recruitment)
measure: Change in total saturated fat ordered for child in restaurant
timeFrame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
measure: Total sugar ordered for child in restaurant
timeFrame: Post-test (about 4 months after recruitment)
measure: Change in total sugar ordered for child in restaurant
timeFrame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
measure: Total sodium ordered for child in restaurant
timeFrame: Post-test (about 4 months after recruitment)
measure: Change in total sodium ordered for child in restaurant
timeFrame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
measure: Dessert ordered for child in restaurant
timeFrame: Post-test (about 4 months after recruitment)
measure: Change in dessert ordered for child in restaurant
timeFrame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
Secondary outcomes:
measure: Calories consumed at restaurant by child in restaurant
timeFrame: Post-test (about 4 months after recruitment)
measure: Changes in calories consumed at restaurant by child in restaurant
timeFrame: Baseline, post-test (about 4 months after recruitment)
measure: Saturated fat consumed at restaurant by child in restaurant
timeFrame: Post-test (about 4 months after recruitment)
measure: Changes in saturated fat consumed at restaurant by child in restaurant
timeFrame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
measure: Sugar consumed at restaurant by child in restaurant
timeFrame: Post-test (about 4 months after recruitment)
measure: Changes in sugar consumed at restaurant by child in restaurant
timeFrame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
measure: Sodium consumed at restaurant by child in restaurant
timeFrame: Post-test (about 4 months after recruitment)
measure: Changes in sodium consumed at restaurant by child in restaurant
timeFrame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
Other outcomes:
measure: Healthier children's meals ordered at aggregate level
timeFrame: Through study completion, an average of 3 years
measure: Healthier children's meals ordered at aggregate level
timeFrame: Exposure period (about 2 months after participant recruitment)
measure: Healthier children's meals ordered at aggregate level
timeFrame: Post-test (about 4 months after participant recruitment)
measure: Changes in kids' meals ordered at aggregate level
timeFrame: 1 year prior to baseline through study completion, an average of 4 years
measure: Total daily calories consumed by child
timeFrame: Post-test (about 4 months after recruitment)
measure: Total saturated fat consumed by child
timeFrame: Post-test (about 4 months after recruitment)
measure: Total sugar consumed by child
timeFrame: Post-test (about 4 months after recruitment)
measure: Total sodium consumed by child
timeFrame: Post-test (about 4 months after recruitment)
Locations:
city: Buffalo
country: United States
facility: State University of New York at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Stephanie Anzman-Frasca, PhD
role: PRINCIPAL_INVESTIGATOR
References: