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Impact of Warnings on Sugar-Sweetened Beverages

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04223687
Recruitment Status : Suspended (Recruitment has been suspended due to COVID-19.)
First Posted : January 10, 2020
Last Update Posted : May 8, 2020
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dietary Habits Other: Sugar-Sweetened Beverage Warning Label Other: Neutral label Not Applicable

Detailed Description:

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.

Assessment: Using an established protocol, participants will visit the mock study convenience store and be given a shopping task to select 1 beverage and 1 snack to purchase for their child ages 2-12. If the participant has more than one child age 2-12, the investigators will randomly select the child they should shop for. At check-out, study staff will record the products selected. Participants will then complete 1 computer-based survey immediately after completing the shopping task. The visit will take approximately 45-60 minutes. At the end of the study, participants will receive an informational handout about sugar-sweetened beverages and healthier alternatives.

Detailed description of the trial arms: Participants will be assigned to either a pictorial warnings arm or a control arm. In the pictorial warnings arm, all sugar-sweetened beverage products in the mock store will be labeled with a pictorial warning label (two different warning labels will be displayed at the same time, but only 1 warning label per product). Investigators developed the text and design of these warning labels using a pre-test. In the control arm, all sugar-sweetened beverage products will be labeled with a neutral label, also developed by the investigators. In both arms, labels will be adhered directly on the front-of-package of sugar-sweetened beverage containers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Evaluating the Impact of Warnings on Sugar-Sweetened Beverages
Actual Study Start Date : January 29, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Sugar-Sweetened Beverage Warning Label Other: Sugar-Sweetened Beverage Warning Label
Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.

Neutral label Other: Neutral label
Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.




Primary Outcome Measures :
  1. Percentage of participants who purchase at least 1 sugar-sweetened beverage for their child [ Time Frame: 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.


Secondary Outcome Measures :
  1. Total calories purchased from sugar-sweetened beverages [ Time Frame: At completion of ~10 minute shopping task, during 1-time study visit ]
    Total calories purchased from sugar-sweetened beverages is defined as the total number of calories of sugar-sweetened beverages in the participant's basket when they complete the shopping task.

  2. Number of sugar-sweetened beverages purchased [ Time Frame: At completion of ~10 minute shopping task, during 1-time study visit ]
    Total number of sugar-sweetened beverages purchased will be recorded by the experimenter when the participant completes the shopping task.

  3. Intention to give sugar-sweetened beverages to child [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Intention to give sugar-sweetened beverages to child will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher amount of the construct.

  4. Percentage of participants who noticed trial label [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Percent of participants who noticed the trial labels will be measured at post-test by survey.

  5. Thinking about harms of drinking sugar-sweetened beverages [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    How much the participant reports thinking about the health problems caused by drinking sugar-sweetened beverages will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct.

  6. Negative affective reactions [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Negative affect will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct.

  7. Anticipated social interactions [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Anticipated social interactions about the study labels will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct.

  8. Percentage of participants who felt more in control of healthy eating decisions [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Percent of participants indicating they felt more in control of healthy eating decisions will be measured at post-test by survey.

  9. Perceived amount of added sugar in sugar-sweetened beverages [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Perceptions of added sugar content in sugar-sweetened beverages will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct.

  10. Perceived likelihood of child experiencing health problems due to sugar-sweetened beverages [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Perceived likelihood of child experiencing sugar-sweetened beverage related health outcomes will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher amount of the construct.

  11. Healthfulness of sugar-sweetened beverages for child [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Parents' perceptions about sugar-sweetened beverages' healthfulness for their child will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher amount of the construct.

  12. Appeal of sugar-sweetened beverages for child [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Parents' perceptions about sugar-sweetened beverages appeal for their child will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher amount of the construct.

  13. Tastiness of sugar-sweetened beverages for child [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Parents' perceptions of tastiness of sugar-sweetened beverages for their child will be measured at post-test by survey. Response options are on a 1 to 7 scale, with higher scores representing a higher amount of the construct.

  14. Injunctive norms about limiting child's sugar-sweetened beverages [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Injunctive norms will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct.


Other Outcome Measures:
  1. Anticipated avoidance of label [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Avoidance of the study labels will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct.

  2. Perceived message effectiveness [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Perceived message effectiveness of the study labels will be measured at post-test by survey. Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct.

  3. Policy support [ Time Frame: Post-test computer survey within 30 minutes following completion of ~10 minute shopping task ]
    Support for sugar-sweetened beverage health warning labels will be measured at post-test by survey. Response options are on a 1 to 4 scale, with higher scores representing a higher amount of the construct.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04223687


Locations
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United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Robert Wood Johnson Foundation
Investigators
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Principal Investigator: Marissa G. Hall, PhD University of North Carolina, Chapel Hill
Principal Investigator: Lindsey S. Taillie, PhD University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
Statistical Analysis Plan  [PDF] January 24, 2020

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04223687    
Other Study ID Numbers: 19-0277b
RWJF76290 ( Other Grant/Funding Number: Robert Wood Johnson Foundation )
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Food and beverage purchases
Sugar-sweetened beverages
Beverages