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临床试验/NCT04223687
NCT04223687已完成不适用

Randomized Controlled Trial Evaluating the Impact of Warnings on Sugar-Sweetened Beverages

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2020年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
326
试验地点
2
主要终点
Percentage of Participants Who Purchase at Least 1 Sugar-sweetened Beverage for Their Child

研究概览

简要总结

The purpose of this randomized controlled trial is to determine whether pictorial warnings on sugar-sweetened beverages are more effective than neutral labels at reducing parents' purchases of sugar-sweetened beverages for their children. Participants will be parents or guardians of at least one child age 2-12. The trial will take place in a mock convenience store. Participants will be randomly assigned to a pictorial warnings arm in which all sugar-sweetened beverages in the store are labeled with pictorial warnings, or to a control arm in which all sugar-sweetened beverages in the store are labeled with a neutral label. All participants will visit the mock convenience store setup based on their randomized trial arm and be instructed to engage in a shopping task. Participants will complete a computer survey after the shopping task.

详细描述

Childhood obesity is a major public health problem in the US among racial and ethnic minorities, including among the US's growing Latino population. One promising but understudied policy for addressing childhood obesity is requiring pictorial warnings on the front of sugar-sweetened beverage containers. The impact of pictorial warnings in real-world food retail environments on parents' sugar-sweetened beverage purchasing behavior for their children is unknown. This study will assess the impact of pictorial warnings on parents' sugar-sweetened beverage purchases for their children in a real-world randomized controlled trial. The investigators focus on parents as they are the primary decision-makers and purchasers of food products for children and exert strong influence over their children's dietary intake and food attitudes. Half of participants will be Latino as childhood obesity is a major public health problem among the US's growing Latino population.

Setting: The trial will take place in a mock convenience store setting created for researchers to examine how store and product characteristics influence consumer purchases in a controlled but realistic environment. The store reflects a convenience store's characteristics, with foods, beverages, and household items set at real-world prices.

Recruitment: Participants will be recruited locally via methods including community subject pools, printed flyers posted, and online listings. Interested potential participants will complete a screening questionnaire online, in person, or over the phone to determine their eligibility. If eligible, they will be invited to schedule a time to visit the mock store for the trial.

Informed Consent: At the beginning of the in-person study visit, study staff will explain the consent form. The study staff will ask the participant if he or she has any questions; once the participant consents to the study, both parties will sign the consent form and the participant will receive a copy of the consent form.

Randomization: After the participant signs the consent form, study staff will randomly assign participants to one of the two study arms. Randomization order will be determined a priori. Participants will have an equal chance of being randomized to either arm of the trial.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be 18 years or older
  • Be able to read and speak English or Spanish
  • Be able to take a computer survey in English or Spanish
  • Be the parent or guardian to at least one child between the ages of 2 and 12 who consumed at least one sugar-sweetened beverage in the week prior to taking the screener

排除标准

  • Cannot have participated in the investigator's previous study at the convenience store in the past year
  • Cannot live in the same household as another enrolled study participant

结局指标

主要结局

Percentage of Participants Who Purchase at Least 1 Sugar-sweetened Beverage for Their Child

时间窗: At completion of ~10 minute shopping task, during 1-time study visit

The primary outcome is the percent of participants who selected at least one sugar-sweetened beverage for their child during the shopping task. Purchases will be recorded by the experimenter when they complete the shopping task.

次要结局

  • Mean Total Calories Purchased From Sugar-sweetened Beverages(At completion of ~10 minute shopping task, during 1-time study visit)
  • Mean Intention to Give Sugar-sweetened Beverages to Child(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Percentage of Participants Who Noticed Trial Label(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean Thinking About Harms of Drinking Sugar-sweetened Beverages(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean Negative Affective Reactions(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean Anticipated Social Interactions(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Percentage of Participants Who Felt More in Control of Healthy Eating Decisions(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean Perceived Amount of Added Sugar in Sugar-sweetened Beverages(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean Perceived Likelihood of Child Experiencing Health Problems Due to Sugar-sweetened Beverages(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean Healthfulness of Sugar-sweetened Beverages for Child(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean Appeal of Sugar-sweetened Beverages for Child(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean Tastiness of Sugar-sweetened Beverages for Child(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)
  • Mean Injunctive Norms About Limiting Child's Sugar-sweetened Beverages(Post-test computer survey within 30 minutes following completion of ~10 minute shopping task)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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