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临床试验/NCT03511937
NCT03511937已完成不适用

A Randomized Controlled Trial Evaluating the Impact of Sugar-Sweetened Beverage Health Warnings on Purchases

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年5月11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
400
试验地点
2
主要终点
Mean Number of Calories (kcal) Purchased From Sugar-sweetened Beverages

研究概览

简要总结

Consumption of sugar-sweetened beverages (SSBs) like sodas, sports drinks, and fruit drinks remains a pressing public health concern in the United States. Consumption of SSBs remains well above recommended levels, and has been linked to obesity, diabetes, and cardiovascular disease. In response, policymakers across the U.S. have proposed requiring warning messages on SSB containers to inform the public and reduce consumption to healthier levels. While online studies find that such warnings reduce intentions to purchase SSBs, no studies have yet examined the impact of warnings on actual consumer behavior. The purpose of this randomized trial is to determine whether health warnings on sugar-sweetened beverages are more effective than control labels at reducing purchases of sugar-sweetened beverages. The trial will take place in a mock convenience store. Participants will be randomly assigned to a health warnings arm in which all sugar-sweetened beverages in the store are labeled with a health warning, or to a control arm in which all sugar-sweetened beverages in the store are labeled with a neutral label. Participants will select items to purchase with cash, and purchases will be compared across trial arms.

详细描述

Background: Obesity, diabetes and cardiovascular disease are among the leading causes of death in the United States. Consumption of sugar-sweetened beverages (SSBs) such as sodas, fruit drinks and sports drinks increases risk of these preventable conditions. SSBs are particularly problematic because they are high in calories but offer little nutritional value, and because the liquid calories in SSBs cause faster spikes in blood sugar and lower feelings of fullness than solid foods.

Despite these risks, the average American adult consumes more than 130 calories per day from SSBs, well above recommended levels. A promising strategy for reducing SSB consumption is requiring health warnings on SSB containers. Online studies show that health warnings attract consumers' attention and reduce intentions to purchase SSBs. However, no research has tested the impact of SSB health warnings on actual behaviors. This randomized trial evaluates whether health warnings reduce purchases of SSBs.

Setting: The trial will take place 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, selling foods, beverages, and household items at real-world prices. Participants can buy these products using cash.

Recruitment: Participants will be recruited via university community subject pools, printed flyers posted, and online listings. Interested potential participants will complete an online pre-enrollment screening questionnaire 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 study visit, research staff will review the consent documents with the participants. After reviewing the form, the research staff member will ask the participant if he or she has any questions. Then both parties will sign the consent form and the participant will receive a copy of the consent form to keep.

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
Single (Participant)

盲法说明

This trial uses incomplete disclosure to mask the purpose of the trial from participants.

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

  • Age 18 years or older
  • Consume at least 12oz/week of sugar-sweetened beverages during the past month
  • Be able to read and speak English

排除标准

  • Under the age of 18 years
  • Consume less than 12 ounces/week of sugar-sweetened beverages during the past month
  • Unable to read or speak English

结局指标

主要结局

Mean Number of Calories (kcal) Purchased From Sugar-sweetened Beverages

时间窗: At completion of ~10-minute shopping task

The primary outcome is calories of sugar-sweetened beverages purchased during the shopping task. Calories from sugar-sweetened beverage purchases is defined as the total number of calories from sugar-sweetened beverages in the participant's basket when they complete the shopping task, calculated as the sum of calories/container for all SSB containers. Purchases will be recorded by the experimenter immediately after the participant completes the \~10-minute shopping task.

次要结局

  • Percent of Participants Who Purchase a Sugar-sweetened Beverage(At completion of ~10-minute shopping task)
  • Mean Number of Calories (kcal) Purchased From All Foods and Beverages(At completion of ~10-minute shopping task)
  • Mean Number of Sugar-sweetened Beverages Purchased(At completion of ~10 minute shopping task)
  • Mean Intentions Score to Limit Consumption of Beverages Added Sugar(Within 30 minutes following completion of ~10-minute shopping task)
  • Mean Social Interactions About the Labels(Within 30 minutes following completion of ~10-minute shopping task)
  • Mean Perceptions of Added Sugar Score Content in Specific Sugar-sweetened Beverages(Within 30 minutes following completion of ~10-minute shopping task)
  • Mean Product Attitudes Score Toward Specific Sugar-sweetened Beverages(Within 30 minutes following completion of ~10-minute shopping task)
  • Mean Emotional Reactions Score to Trial Labels(Within 30 minutes following completion of ~10-minute shopping task)
  • Mean Attention Score to the Trial Labels(Within 30 minutes following completion of ~10-minute shopping task)
  • Mean Intentions Sore to Limit Consumption of Specific Sugar-sweetened Beverages(Within 30 minutes following completion of ~10-minute shopping task)
  • Percent of Participants Who Notice the Trial Labels(Within 30 minutes following completion of ~10-minute shopping task)
  • Mean Cognitive Elaboration Score(Within 30 minutes following completion of ~10-minute shopping task)
  • Mean Attitudes Score Toward Consuming Specific Sugar-sweetened Beverages(Within 30 minutes following completion of ~10-minute shopping task)
  • Mean Outcome Expectations Score Regarding Consumption of Beverages With Added Sugar(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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