- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04334525
Promoting Healthier Eating Among Children in Restaurants
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara Tauriello, MS
- Phone Number: 7168296694
- Email: sarataur@buffalo.edu
Study Contact Backup
- Name: Clifford Minter, MPH
- Phone Number: 7168075673
- Email: cdminter@buffalo.edu
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14214
- Recruiting
- State University of New York at Buffalo
-
Contact:
- Stephanie Anzman-Frasca, PhD
- Phone Number: 716-829-6692
- Email: safrasca@buffalo.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Generic placemats and frequent diner cards
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.
|
|
Experimental: Placemats and frequent diner cards promoting healthier meals
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Meal type ordered for child in restaurant
Time Frame: Post-test (about 4 months after recruitment)
|
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
Time Frame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
|
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
Time Frame: Post-test (about 4 months after recruitment)
|
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
Time Frame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
|
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
Time Frame: Post-test (about 4 months after recruitment)
|
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
Time Frame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
|
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
Time Frame: Post-test (about 4 months after recruitment)
|
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
Time Frame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
|
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
Time Frame: Post-test (about 4 months after recruitment)
|
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
Time Frame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
|
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
Time Frame: Post-test (about 4 months after recruitment)
|
Whether or not a dessert was ordered
|
Post-test (about 4 months after recruitment)
|
Change in dessert ordered for child in restaurant
Time Frame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calories consumed at restaurant by child in restaurant
Time Frame: Post-test (about 4 months after recruitment)
|
Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total calories in the full item to calculate calories consumed.
|
Post-test (about 4 months after recruitment)
|
Changes in calories consumed at restaurant by child in restaurant
Time Frame: Baseline, post-test (about 4 months after recruitment)
|
Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total calories in the full item to calculate calories consumed.
|
Baseline, post-test (about 4 months after recruitment)
|
Saturated fat consumed at restaurant by child in restaurant
Time Frame: Post-test (about 4 months after recruitment)
|
Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total saturated fat in the full item to calculate saturated fat consumed.
|
Post-test (about 4 months after recruitment)
|
Changes in saturated fat consumed at restaurant by child in restaurant
Time Frame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
|
Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total saturated fat in the full item to calculate saturated fat consumed.
|
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
Time Frame: Post-test (about 4 months after recruitment)
|
Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total sugar in the full item to calculate sugar consumed.
|
Post-test (about 4 months after recruitment)
|
Changes in sugar consumed at restaurant by child in restaurant
Time Frame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
|
Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total sugar in the full item to calculate sugar consumed.
|
Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
|
Sodium consumed at restaurant by child in restaurant
Time Frame: Post-test (about 4 months after recruitment)
|
Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total sodium in the full item to calculate sodium consumed.
|
Post-test (about 4 months after recruitment)
|
Changes in sodium consumed at restaurant by child in restaurant
Time Frame: Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
|
Children's dietary intake will be measured using plate waste methodology.
Grams consumed will be converted to percentages using total grams from pre-weights, and these percentages will be multiplied by the total sodium in the full item to calculate sodium consumed.
|
Baseline, midpoints 1-6 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthier children's meals ordered at aggregate level
Time Frame: Through study completion, an average of 3 years
|
Aggregated sales data from the restaurant will be collected to monitor sales of healthier kids' meals across all patrons in Anderson's restaurants by study group during the study period.
|
Through study completion, an average of 3 years
|
Healthier children's meals ordered at aggregate level
Time Frame: Exposure period (about 2 months after participant recruitment)
|
Aggregated sales data from the restaurant will be collected to monitor sales of healthier kids' meals across all patrons in Anderson's restaurants by study group during the exposure period.
|
Exposure period (about 2 months after participant recruitment)
|
Healthier children's meals ordered at aggregate level
Time Frame: Post-test (about 4 months after participant recruitment)
|
Aggregated sales data from the restaurant will be collected to monitor sales of healthier kids' meals across all patrons in Anderson's restaurants by study group during the redemption/post-test period.
|
Post-test (about 4 months after participant recruitment)
|
Changes in kids' meals ordered at aggregate level
Time Frame: 1 year prior to baseline through study completion, an average of 4 years
|
Aggregated sales data from the restaurant will be collected to monitor sales of kids' meals across all patrons in Anderson's restaurants during the recruitment/baseline, exposure, and redemption/post-test periods and parallel time points one year prior.
|
1 year prior to baseline through study completion, an average of 4 years
|
Total daily calories consumed by child
Time Frame: Post-test (about 4 months after recruitment)
|
Parents will report children's daily dietary intake using the Automated Self-administered 24-hour Dietary Assessment Tool (ASA24) the day after the in-restaurant part of the post-test assessment.
|
Post-test (about 4 months after recruitment)
|
Total saturated fat consumed by child
Time Frame: Post-test (about 4 months after recruitment)
|
Parents will report children's daily dietary intake using the Automated Self-administered 24-hour Dietary Assessment Tool (ASA24) the day after the in-restaurant part of the post-test assessment.
|
Post-test (about 4 months after recruitment)
|
Total sugar consumed by child
Time Frame: Post-test (about 4 months after recruitment)
|
Parents will report children's daily dietary intake using the Automated Self-administered 24-hour Dietary Assessment Tool (ASA24) the day after the in-restaurant part of the post-test assessment.
|
Post-test (about 4 months after recruitment)
|
Total sodium consumed by child
Time Frame: Post-test (about 4 months after recruitment)
|
Parents will report children's daily dietary intake using the Automated Self-administered 24-hour Dietary Assessment Tool (ASA24) the day after the in-restaurant part of the post-test assessment.
|
Post-test (about 4 months after recruitment)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stephanie Anzman-Frasca, PhD, University at Buffalo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00003356
- 1R01HD096748-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diet, Healthy
-
University of ReadingActive, not recruitingDiet Modification | Diet, Healthy | Diet HabitUnited Kingdom
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
Washington State UniversityUnited States Department of Agriculture (USDA)Not yet recruitingHealth Behavior | Diet, Healthy | Diet HabitUnited States
-
University of HawaiiPennington Biomedical Research Center; United States Department of Agriculture...RecruitingDiet, HealthyUnited States
-
Harokopio UniversityRecruiting
-
Universitas Katolik Widya Mandala SurabayaNot yet recruitingDiet, HealthyIndonesia
-
Ohio State University Comprehensive Cancer CenterRecruitingHealthy DietUnited States
-
Purdue UniversityMushroom CouncilCompleted
-
University of PalermoCompleted
Clinical Trials on Choice architecture + repeated exposure
-
Harvard School of Public Health (HSPH)Massachusetts General Hospital; Duke University; University of New EnglandCompletedFood Habits | Consumer Behavior
-
University of PennsylvaniaNot yet recruiting
-
Harvard School of Public Health (HSPH)CompletedFood Habits | Meals
-
Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID); University of...Completed
-
University of Colorado, DenverTemple University; Vitamix FoundationRecruiting
-
Johns Hopkins UniversityAurum Institute; KNCV Tuberculosis Foundation; Clinton Health Access Initiative...CompletedHIV/AIDS | TuberculosisMalawi, Mozambique, Zimbabwe
-
United States Army Research Institute of Environmental...RecruitingCold ExposureUnited States
-
University of MinnesotaNational Institute on Drug Abuse (NIDA)RecruitingOpioid Use | Opioid Abuse | Opioid-use DisorderUnited States
-
University of MinnesotaNational Institute on Drug Abuse (NIDA)CompletedOpioid Use | Opioid Abuse | Opioid-use DisorderUnited States
-
State University of New York at BuffaloActive, not recruitingOvernutrition | Pediatric Obesity | Obesity, Childhood | Overweight, Childhood | Eating, HealthyUnited States