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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD096748-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Generic placemats and frequent diner cards | Active Comparator | 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. |
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| 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. |
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| Pilot phase | No Intervention | Pilot (taste testing) phase completed before the trial to finalize the healthier meals that would be promoted in the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Choice architecture + repeated exposure | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Meal Type Ordered for Child in Restaurant | Whether a healthier children's meal or other children's meal was ordered (bundled meal including promoted healthy main dish, healthy side, and healthy beverage). Counts reported indicate the number of children who ordered a healthy bundled meal. | 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. Counts reflect the raw change in number of participants ordering the bundled healthy meal from baseline to post-test, by group. | Baseline, midpoints 1-9 (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) |
| Change 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 1-9 (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 |
| Measure | Description | Time Frame |
|---|---|---|
| Calories Consumed at Restaurant by Child in Restaurant | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Healthier Children's Meals Ordered at Aggregate Level | 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. Children's orders were studied in aggregate; thus individual study participants were not studied here. | Through study completion, an average of 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Anzman-Frasca, PhD | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of New York at Buffalo | Buffalo | New York | 14214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41072006 | Derived | 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. |
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Four participants were excluded from randomization to groups because they did not complete necessary baseline procedures (providing complete data on child's order at baseline). Generally this was because families changed their minds about participating between consenting and providing this information.
For the RCT, 240 parents and 240 children were recruited and enrolled in restaurants over four cohorts (Summer 2021-Summer 2024). 236 of the families were randomized as described herein. Recruitment occurred across the restaurants' 6 locations, 2 per year. Prior to this, 74 participants (37 parents, 37 children) participated in a pilot phase to finalize the promoted meals for the study. Those in the pilot phase were not involved in the RCT and were never randomized.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. Choice architecture + repeated exposure: 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. |
| FG002 | Pilot Phase | Taste testing in a separate arm that occurred prior to randomization |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1. Pilot Phase |
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| 2. Main Phase (RCT) |
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Above sample sizes reflect the total number of parents and children for whom baseline demographic data are available (105 families - 1 parent, 1 child in each, in control group; 129 families - 1 parent, 1 child in each, in intervention group, 74 families - 1 parent, 1 child in each during pilot phase). 234 of 236 families in the randomized RCT sample provided demographics. Measure analysis population description section below indicates the population specific demographics correspond to.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Child age at enrollment based on parent reported birth date (intervention and control group). For the pilot phase, specific age was not recorded (children were categorized as older vs. younger). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Meal Type Ordered for Child in Restaurant | Whether a healthier children's meal or other children's meal was ordered (bundled meal including promoted healthy main dish, healthy side, and healthy beverage). Counts reported indicate the number of children who ordered a healthy bundled meal. | Sample is those with post-test order data. Results for all pre-registered outcomes are from initial models without additional covariates. Please note that the pre-registered outcomes (all of them) were only collected in the intervention (placemats and frequent diner cards promoting healthier meals) and control (generic placemats and frequent diner cards) groups and not during the pilot phase. | Posted | Count of Participants | Participants | Post-test (about 4 months after recruitment) |
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Adverse event data were collected throughout the study (four years of data collection, with each participant enrolled for about 4 months)
The definitions do not differ
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Anzman-Frasca | SUNY Buffalo | 716-829-6692 | safrasca@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2024 | Feb 25, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 31, 2023 | Jan 13, 2026 | ICF_001.pdf |
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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. There is also a pilot arm, consisting of separate children participating in taste tests prior to randomization to finalize the healthier meals to be promoted in the intervention.
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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.
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| Active comparator | Behavioral | Participants receive generic placemats and frequent diner cards that do not promote any specific kids' meal. |
|
Nutrition information provided by the restaurant will be combined with parent report of children's orders to calculate total saturated fat ordered. |
| Baseline, midpoints 1-9 (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 1-9 (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 1-9 (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. Counts below reflect the number of children ordering a dessert at post-test. | Post-test (about 4 months after recruitment) |
| Change in Dessert Ordered for Child in Restaurant | Whether or not a dessert was ordered. Numbers below reflect change in likelihood of ordering dessert from baseline to post-test in the context of the generalized linear mixed model with all time points (baseline, midpoints 1-9, post-test). | Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment) |
| Changes in Calories Consumed at Restaurant by Child in Restaurant | 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 | 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 | 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, post-test (about 4 months after recruitment) |
| Sugar Consumed at Restaurant by Child in Restaurant | 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 | 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, post-test (about 4 months after recruitment) |
| Sodium Consumed at Restaurant by Child in Restaurant | 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 | 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, post-test (about 4 months after recruitment) |
| Healthier Children's Meals Ordered at Aggregate Level | 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. Given that the intervention experienced by the general population (as opposed to study participants) is the same during midpoints and post-test, note that here exposure refers to midpoints plus post-test as described in a priori published protocol paper. Children's orders were studied in aggregate; thus individual study participants were not studied here. | Exposure period (lasting from about 2 to about 4 months after participant recruitment) |
| Healthier Children's Meals Ordered at Aggregate Level | 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 baseline period. Only aggregate data were recorded here; no data for individual child participants are available. | Baseline |
| Changes in Kids' Meals Ordered at Aggregate Level | Aggregated sales data from the restaurant will be collected to monitor sales of kids' meals across all patrons in Anderson's restaurants during time points parallel to the exposure period, 1 and 2 years prior to the study (for historical comparison). 2 years was added after original study planning but before study completion, given that 1 year prior to the study was 2020, a year impacted by the COVID-19 pandemic. Only aggregate data were recorded here (no individual participant data). Values from the two time points (1 year prior and 2 years prior) are summed. | 1 and 2 years prior to study exposure period |
| Total Daily Calories Consumed by Child | 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 | 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 | 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 | 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) |
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| BG001 | 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. Choice architecture + repeated exposure: 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. |
| BG002 | Pilot Phase | Families recruiting for taste testing prior to the main RCT |
| BG003 | Total | Total of all reporting groups |
Age here refers to the child, which is why the sample size differs from overall number of participants (parent and child). Parent demographics were entered subsequently. Two randomized families did not provide demographic information. |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Child sex reported by parent (intervention and control). In the pilot phase child sex was not recorded. | Sex here refers to the child, which is why the sample size differs from overall number of participants (parent and child). Parent demographics were entered subsequently. Two randomized families did not provide demographic information. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race/ethnicity here refers to the child, which is why the sample size differs from overall number of participants (parent and child). Parent demographics were entered subsequently. Two randomized families did not provide demographic information. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Parent age (continuous) | Parent age at enrollment based on reported birth date (intervention and control). Parent age not recorded in the pilot phase. | Age here refers to the parent, which is why the sample size differs from overall number of participants (parent and child). Two randomized families did not provide demographic information. | Mean | Standard Deviation | years |
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| Parent sex (male/female) | Parent reported at enrollment/baseline (intervention and control). In the pilot phase, this was inferred from report of being the mother or the father. | Sex here refers to the parent, which is why the sample size differs from overall number of participants (parent and child). Two randomized families did not provide demographic information. | Count of Participants | Participants |
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| Parent race/ethnicity, customized | Not collected in pilot phase | Race/ethnicity here refers to the parent, which is why the sample size differs from overall number of participants (parent and child). Two randomized families did not provide demographic information. | Count of Participants | Participants |
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| OG001 | 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. Choice architecture + repeated exposure: 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. |
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| Primary | Change in Meal Type Ordered for Child in Restaurant | Whether a healthier children's meal or other children's meal was ordered. Counts reflect the raw change in number of participants ordering the bundled healthy meal from baseline to post-test, by group. | Because generalized linear mixed model (planned analysis) would not converge for this outcome (due to quasi separation of data) we present, among those with post-test data, the raw change in number of participants ordering the healthy meal from baseline to post-test, by group. | Posted | Count of Participants | Participants | Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment) |
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| Primary | 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 | Sample sizes reflect number of participants included overall in the repeated measures model that includes all available data from all randomized participants at each time point. | Posted | Least Squares Mean | Standard Error | calories | Post-test (about 4 months after recruitment) |
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| Primary | Change 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 | LS means reflect the average change from baseline to post-test in the context of the model including all data from all randomized participants at all time points (full information maximum likelihood). Sample sizes reflect overall sample size in this model. | Posted | Least Squares Mean | Standard Error | calories | Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment) |
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| Primary | 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. | Sample sizes reflects number of families in the overall mixed model which includes all available data from all randomized families at all time points. | Posted | Least Squares Mean | Standard Error | grams | Post-test (about 4 months after recruitment) |
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| Primary | 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. | Least squares means reflect the change from baseline to post-test in the context of the model including all data from all randomized participants at all study time points. Sample sizes reflect overall sample size in this model. | Posted | Least Squares Mean | Standard Error | grams | Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment) |
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| Primary | 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. | Sample sizes reflects number of families in the overall mixed model which includes all available data from all randomized families at all time points. | Posted | Least Squares Mean | Standard Error | grams | Post-test (about 4 months after recruitment) |
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| Primary | 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. | LSmeans reflect the average change from baseline to post-test in the context of the model including all data from all randomized participants at all time points (full information maximum likelihood). Sample sizes reflect overall sample size in this model. | Posted | Least Squares Mean | Standard Error | grams | Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment) |
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| Primary | 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. | Sample sizes reflects number of families in the overall mixed model which includes all available data from all randomized families at all time points. | Posted | Least Squares Mean | Standard Error | milligrams | Post-test (about 4 months after recruitment) |
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| Primary | 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. | LS means reflect the change from baseline to post-test in the context of the model including all data from all randomized participants at all time points (full information maximum likelihood). Sample sizes reflect overall sample size in this model. | Posted | Least Squares Mean | Standard Error | milligrams | Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment) |
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| Primary | Dessert Ordered for Child in Restaurant | Whether or not a dessert was ordered. Counts below reflect the number of children ordering a dessert at post-test. | Sample size reflects those with post-test order data | Posted | Count of Participants | Participants | Post-test (about 4 months after recruitment) |
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| Primary | Change in Dessert Ordered for Child in Restaurant | Whether or not a dessert was ordered. Numbers below reflect change in likelihood of ordering dessert from baseline to post-test in the context of the generalized linear mixed model with all time points (baseline, midpoints 1-9, post-test). | Sample size reflects sample with order data (n=236). Numbers below reflect change in likelihood of ordering dessert from baseline to post-test in the context of the generalized linear mixed model with all time points (baseline, midpoints 1-9, post-test). | Posted | Least Squares Mean | Standard Error | change in probability | Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment) |
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| Secondary | Calories Consumed at Restaurant by Child in Restaurant | 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. | Sample size includes those with intake data at post-test. The first cohort did not have intake assessed due to COVID-19, so these cases are excluded as well as any Cohort 2-4 cases for whom it was not possible to collect all intake data. LS means are in the context of the model with data from all randomized participants at all time points as which intake data were collected (baseline and post-test only, among the aforementioned sample. Intake was not assessed at the midpoints). | Posted | Least Squares Mean | Standard Error | calories | Post-test (about 4 months after recruitment) |
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| Secondary | Changes in Calories Consumed at Restaurant by Child in Restaurant | 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. | Sample size includes all those with in intake data analysis models. The first cohort did not have intake assessed due to COVID-19, so these cases are excluded as well as any Cohort 2-4 cases for whom it was not possible to collect all intake data. LS means are in the context of the model with data from all randomized participants at all time points as which intake data were collected (baseline and post-test only, among the aforementioned sample. Intake was not assessed at the midpoints). | Posted | Least Squares Mean | Standard Error | calories | Baseline, post-test (about 4 months after recruitment) |
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| Secondary | Saturated Fat Consumed at Restaurant by Child in Restaurant | 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. | Sample size includes those with intake data at post-test. The first cohort did not have intake assessed due to COVID-19, so these cases are excluded as well as any Cohort 2-4 cases for whom it was not possible to collect all intake data. LS means are in the context of the model with data from all randomized participants at all time points as which intake data were collected (baseline and post-test only, among the aforementioned sample. Intake was not assessed at the midpoints). | Posted | Least Squares Mean | Standard Error | grams | Post-test (about 4 months after recruitment) |
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| Secondary | Changes in Saturated Fat Consumed at Restaurant by Child in Restaurant | 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. | Sample size includes all those with in intake data analysis models. The first cohort did not have intake assessed due to COVID-19, so these cases are excluded as well as any Cohort 2-4 cases for whom it was not possible to collect all intake data. LS means are in the context of the model with data from all randomized participants at all time points as which intake data were collected (baseline and post-test only, among the aforementioned sample. Intake was not assessed at the midpoints). | Posted | Least Squares Mean | Standard Error | grams | Baseline, post-test (about 4 months after recruitment) |
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| Secondary | Sugar Consumed at Restaurant by Child in Restaurant | 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. | Sample size includes those with intake data at post-test. The first cohort did not have intake assessed due to COVID-19, so these cases are excluded as well as any Cohort 2-4 cases for whom it was not possible to collect all intake data. LS means are in the context of the model with data from all randomized participants at all time points as which intake data were collected (baseline and post-test only, among the aforementioned sample. Intake was not assessed at the midpoints). | Posted | Least Squares Mean | Standard Error | grams | Post-test (about 4 months after recruitment) |
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| Secondary | Changes in Sugar Consumed at Restaurant by Child in Restaurant | 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. | Sample size includes all those with in intake data analysis models. The first cohort did not have intake assessed due to COVID-19, so these cases are excluded as well as any Cohort 2-4 cases for whom it was not possible to collect all intake data. LS means are in the context of the model with data from all randomized participants at all time points as which intake data were collected (baseline and post-test only, among the aforementioned sample. Intake was not assessed at the midpoints). | Posted | Least Squares Mean | Standard Error | grams | Baseline, post-test (about 4 months after recruitment) |
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| Secondary | Sodium Consumed at Restaurant by Child in Restaurant | 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. | Sample size includes those with intake data at post-test. The first cohort did not have intake assessed due to COVID-19, so these cases are excluded as well as any Cohort 2-4 cases for whom it was not possible to collect all intake data. LS means are in the context of the model with data from all randomized participants at all time points as which intake data were collected (baseline and post-test only, among the aforementioned sample. Intake was not assessed at the midpoints). | Posted | Least Squares Mean | Standard Error | milligrams | Post-test (about 4 months after recruitment) |
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| Secondary | Changes in Sodium Consumed at Restaurant by Child in Restaurant | 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. | Sample size includes all those with in intake data analysis models. The first cohort did not have intake assessed due to COVID-19, so these cases are excluded as well as any Cohort 2-4 cases for whom it was not possible to collect all intake data. LS means are in the context of the model with data from all randomized participants at all time points as which intake data were collected (baseline and post-test only, among the aforementioned sample. Intake was not assessed at the midpoints). | Posted | Least Squares Mean | Standard Error | milligrams | Baseline, post-test (about 4 months after recruitment) |
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| Other Pre-specified | Healthier Children's Meals Ordered at Aggregate Level | 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. Children's orders were studied in aggregate; thus individual study participants were not studied here. | These are sales data (all children's menu sales in the restaurant during the study period), which is why the numbers are larger than the total sample sizes for the enrolled study population. Sample size reflects all children's orders during the study period, given outcome here is percentage of all children's orders during study period (all time points, all cohorts) that were for promoted healthier items. | Posted | Number | healthy orders | Through study completion, an average of 3 years | Children's orders | Children's orders |
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| Other Pre-specified | Healthier Children's Meals Ordered at Aggregate Level | 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. Given that the intervention experienced by the general population (as opposed to study participants) is the same during midpoints and post-test, note that here exposure refers to midpoints plus post-test as described in a priori published protocol paper. Children's orders were studied in aggregate; thus individual study participants were not studied here. | These are sales data (all children's menu sales in the restaurant during the exposure period), which is why the numbers are larger than the total sample sizes for the enrolled study population. | Posted | Number | healthy orders | Exposure period (lasting from about 2 to about 4 months after participant recruitment) | Children's orders | Children's orders |
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| Other Pre-specified | Healthier Children's Meals Ordered at Aggregate Level | 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 baseline period. Only aggregate data were recorded here; no data for individual child participants are available. | These are sales data (all children's menu sales in the restaurant during the baseline period), which is why the numbers are larger than the total sample sizes for the enrolled study population. Analysis of group differences during this period can serve as a point of comparison for differences during the exposure (intervention) period. | Posted | Number | healthy orders | Baseline | Children's orders | Children's orders |
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| Other Pre-specified | Changes in Kids' Meals Ordered at Aggregate Level | Aggregated sales data from the restaurant will be collected to monitor sales of kids' meals across all patrons in Anderson's restaurants during time points parallel to the exposure period, 1 and 2 years prior to the study (for historical comparison). 2 years was added after original study planning but before study completion, given that 1 year prior to the study was 2020, a year impacted by the COVID-19 pandemic. Only aggregate data were recorded here (no individual participant data). Values from the two time points (1 year prior and 2 years prior) are summed. | These are sales data (all children's menu sales in the restaurant during the indicated period), which is why the numbers are larger than the total sample sizes for the enrolled study population. | Posted | Number | healthy orders | 1 and 2 years prior to study exposure period | Children's orders | Children's orders |
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| Other Pre-specified | Total Daily Calories Consumed by Child | 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. | This analysis examines study group differences among all families with 24-hour dietary recall data at post-test (n=153). | Posted | Least Squares Mean | Standard Error | calories | Post-test (about 4 months after recruitment) |
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| Other Pre-specified | Total Saturated Fat Consumed by Child | 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. | This analysis examines study group differences among all families with 24-hour dietary recall data at post-test (n=153). | Posted | Least Squares Mean | Standard Error | grams | Post-test (about 4 months after recruitment) |
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| Other Pre-specified | Total Sugar Consumed by Child | 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. | This analysis examines study group differences among all families with 24-hour dietary recall data at post-test (n=153). | Posted | Least Squares Mean | Standard Error | grams | Post-test (about 4 months after recruitment) |
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| Other Pre-specified | Total Sodium Consumed by Child | 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. | This analysis examines study group differences among all families with 24-hour dietary recall data at post-test (n=153). | Posted | Least Squares Mean | Standard Error | grams | Post-test (about 4 months after recruitment) |
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| 0 |
| 214 |
| 0 |
| 214 |
| 0 |
| 214 |
| EG001 | 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. Choice architecture + repeated exposure: 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. | 0 | 258 | 0 | 258 | 0 | 258 |
| EG002 | Pilot Phase | Families taste testing meals prior to the main RCT | 0 | 74 | 0 | 74 | 0 | 74 |
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