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临床试验/NCT04334525
NCT04334525已完成不适用

Promoting Healthier Eating Among Children in Restaurants

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 554 人开始时间: 2019年11月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
554
试验地点
1
主要终点
Change in meal type ordered for child in restaurant

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

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.

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Choice architecture + repeated exposure (Behavioral)

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.

干预措施: Active comparator (Behavioral)

Pilot phase

No Intervention

Pilot (taste testing) phase completed before the trial to finalize the healthier meals that would be promoted in the intervention.

结局指标

主要结局

Change in meal type ordered for child in restaurant

时间窗: 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

Child in total calories ordered for child in restaurant

时间窗: 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

Change in dessert ordered for child in restaurant

时间窗: 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

Total calories ordered for child in restaurant

时间窗: 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

Total sugar ordered for child in restaurant

时间窗: 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.

Change in total sugar ordered for child in restaurant

时间窗: 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.

Meal type ordered for child in restaurant

时间窗: Post-test (about 4 months after recruitment)

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

Total sodium ordered for child in restaurant

时间窗: 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.

Total saturated fat ordered for child in restaurant

时间窗: 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.

Change in total saturated fat ordered for child in restaurant

时间窗: 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.

Change in total sodium ordered for child in restaurant

时间窗: 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.

Dessert ordered for child in restaurant

时间窗: Post-test (about 4 months after recruitment)

Whether or not a dessert was ordered

Meal Type Ordered for Child in Restaurant

时间窗: Post-test (about 4 months after recruitment)

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.

Change in Meal Type Ordered for Child in Restaurant

时间窗: Baseline, midpoints 1-9 (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. Counts reflect the raw change in number of participants ordering the bundled healthy meal from baseline to post-test, by group.

Total Calories Ordered for Child in Restaurant

时间窗: 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

Change in Total Calories Ordered for Child in Restaurant

时间窗: Baseline, midpoints 1-9 (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

Total Saturated Fat Ordered for Child in Restaurant

时间窗: 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.

Change in Total Saturated Fat Ordered for Child in Restaurant

时间窗: Baseline, midpoints 1-9 (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.

Total Sugar Ordered for Child in Restaurant

时间窗: 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.

Change in Total Sugar Ordered for Child in Restaurant

时间窗: Baseline, midpoints 1-9 (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.

Total Sodium Ordered for Child in Restaurant

时间窗: 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.

Change in Total Sodium Ordered for Child in Restaurant

时间窗: Baseline, midpoints 1-9 (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.

Dessert Ordered for Child in Restaurant

时间窗: Post-test (about 4 months after recruitment)

Whether or not a dessert was ordered. Counts below reflect the number of children ordering a dessert at post-test.

Change in Dessert Ordered for Child in Restaurant

时间窗: Baseline, midpoints 1-9 (weekly assessments about 2 months after recruitment), post-test (about 4 months after recruitment)

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).

次要结局

  • Calories consumed at restaurant by child in restaurant(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))
  • Changes in sugar 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))
  • Changes in sodium 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))
  • Changes in calories consumed at restaurant by child in restaurant(Baseline, post-test (about 4 months after recruitment))
  • Sugar consumed at restaurant by child in restaurant(Post-test (about 4 months after recruitment))
  • Sodium consumed at restaurant by child in restaurant(Post-test (about 4 months after recruitment))
  • 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, post-test (about 4 months after recruitment))
  • Sugar Consumed at Restaurant by Child in Restaurant(Post-test (about 4 months after recruitment))
  • Changes in Sugar Consumed at Restaurant by Child in Restaurant(Baseline, post-test (about 4 months after recruitment))
  • Sodium Consumed at Restaurant by Child in Restaurant(Post-test (about 4 months after recruitment))
  • Changes in Sodium Consumed at Restaurant by Child in Restaurant(Baseline, post-test (about 4 months after recruitment))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie Anzman-Frasca

Associate Professor

State University of New York at Buffalo

研究点 (1)

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