NCT04334525

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2024

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

March 31, 2020

Last Update Submit

January 9, 2026

Conditions

Keywords

childrestaurantnudgingrepeated exposurediethealth

Outcome Measures

Primary Outcomes (12)

  • Meal type ordered for child in restaurant

    Whether a healthier children's meal or other children's meal was ordered

    Post-test (about 4 months after recruitment)

  • Change in meal type ordered for child in restaurant

    Whether a healthier children's meal or other children's meal was ordered

    Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)

  • Total calories ordered for child in restaurant

    Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total calories ordered

    Post-test (about 4 months after recruitment)

  • Child in total calories ordered for child in restaurant

    Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total calories ordered

    Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)

  • Total saturated fat ordered for child in restaurant

    Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total saturated fat ordered.

    Post-test (about 4 months after recruitment)

  • Change in total saturated fat ordered for child in restaurant

    Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total saturated fat ordered.

    Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)

  • Total sugar ordered for child in restaurant

    Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total sugar ordered.

    Post-test (about 4 months after recruitment)

  • Change in total sugar ordered for child in restaurant

    Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total sugar ordered.

    Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)

  • Total sodium ordered for child in restaurant

    Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total sodium ordered.

    Post-test (about 4 months after recruitment)

  • Change in total sodium ordered for child in restaurant

    Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total sodium ordered.

    Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)

  • Dessert ordered for child in restaurant

    Whether or not a dessert was ordered

    Post-test (about 4 months after recruitment)

  • Change in dessert ordered for child in restaurant

    Whether or not a dessert was ordered

    Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)

Secondary Outcomes (8)

  • Calories consumed at restaurant by child in restaurant

    Post-test (about 4 months after recruitment)

  • Changes in calories consumed at restaurant by child in restaurant

    Baseline, post-test (about 4 months after recruitment)

  • Saturated fat consumed at restaurant by child in restaurant

    Post-test (about 4 months after recruitment)

  • Changes in saturated fat consumed at restaurant by child in restaurant

    Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)

  • Sugar consumed at restaurant by child in restaurant

    Post-test (about 4 months after recruitment)

  • +3 more secondary outcomes

Other Outcomes (8)

  • Healthier children's meals ordered at aggregate level

    Through study completion, an average of 3 years

  • Healthier children's meals ordered at aggregate level

    Exposure period (about 2 months after participant recruitment)

  • Healthier children's meals ordered at aggregate level

    Post-test (about 4 months after participant recruitment)

  • +5 more other outcomes

Study Arms (2)

Generic placemats and frequent diner cards

NO INTERVENTION

Participants will receive generic placemats listing all of the restaurant's kids' meals. Families will also receive a generic frequent diner card, which after purchasing (any) kids' meals across 6 occasions, makes them eligible for a free kids' meal of their choice during a predetermined redemption period. Corresponding signage will be displayed in the restaurant.

Placemats and frequent diner cards promoting healthier meals

EXPERIMENTAL

Participants will receive placemats promoting healthier featured kids' meals and the opportunity to redeem their kids' meal token for a toy instead of dessert. 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. Corresponding signage will be displayed in the restaurant.

Behavioral: Choice architecture + repeated exposure

Interventions

Participants will receive placemats promoting healthier featured kids' meals and the opportunity to redeem their kids' meal token for a toy instead of dessert. 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.

Placemats and frequent diner cards promoting healthier meals

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Fluent in English (parent/guardian \& child)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of New York at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (1)

  • Anzman-Frasca S, Tauriello S, Epstein L, Ferrante MJ, Gampp A, Goldsmith J, Haines J, Leone LA, Paluch R. Promoting Healthier Meal Selection and Intake Among Children in Restaurants: Protocol for a Cluster-Randomized Trial. JMIR Res Protoc. 2025 Oct 10;14:e73618. doi: 10.2196/73618.

Study Officials

  • Stephanie Anzman-Frasca, PhD

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants know which kids' meals are being promoted based on the materials received in each study group -- e.g., placemats and frequent diner cards promoting two featured (healthier) meals vs. all kids' meals -- but the health focus and research questions are not stated explicitly to the participants.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 6, 2020

Study Start

November 13, 2019

Primary Completion

November 22, 2024

Study Completion

November 24, 2024

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations