NCT03511937

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

May 11, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2018

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

March 10, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

April 18, 2018

Results QC Date

February 16, 2021

Last Update Submit

March 9, 2021

Conditions

Keywords

Food and beverage purchasesSugar-sweetened beveragesBeverages

Outcome Measures

Primary Outcomes (1)

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

    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.

    At completion of ~10-minute shopping task

Secondary Outcomes (14)

  • Mean Number of Calories (kcal) Purchased From All Foods and Beverages

    At completion of ~10-minute shopping task

  • Percent of Participants Who Purchase a Sugar-sweetened Beverage

    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 Intentions Sore to Limit Consumption of Specific Sugar-sweetened Beverages

    Within 30 minutes following completion of ~10-minute shopping task

  • +9 more secondary outcomes

Other Outcomes (5)

  • Mean Injunctive Norms Score Regarding Consumption of Beverages With Added Sugar

    Within 30 minutes following completion of ~10-minute shopping task

  • Mean Perceived Message Effectiveness of Trial Label

    Within 30 minutes following completion of ~10-minute shopping task

  • Mean Support for Sugar-sweetened Beverage Health Warning Labels Score

    Within 30 minutes following completion of ~10-minute shopping task

  • +2 more other outcomes

Study Arms (2)

Sugar-Sweetened Beverage Health Warning Label

EXPERIMENTAL
Behavioral: Sugar-Sweetened Beverage Health Warning Label

Neutral Label

OTHER
Other: Neutral Label

Interventions

Labels with a health 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 and on designs described in US and international legislation.

Sugar-Sweetened Beverage Health Warning 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.

Neutral Label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (9)

  • Bollard T, Maubach N, Walker N, Ni Mhurchu C. Effects of plain packaging, warning labels, and taxes on young people's predicted sugar-sweetened beverage preferences: an experimental study. Int J Behav Nutr Phys Act. 2016 Sep 1;13(1):95. doi: 10.1186/s12966-016-0421-7.

    PMID: 27580589BACKGROUND
  • Roberto CA, Wong D, Musicus A, Hammond D. The Influence of Sugar-Sweetened Beverage Health Warning Labels on Parents' Choices. Pediatrics. 2016 Feb;137(2):e20153185. doi: 10.1542/peds.2015-3185. Epub 2016 Jan 14.

    PMID: 26768346BACKGROUND
  • Zoellner J, Estabrooks PA, Davy BM, Chen YC, You W. Exploring the theory of planned behavior to explain sugar-sweetened beverage consumption. J Nutr Educ Behav. 2012 Mar-Apr;44(2):172-7. doi: 10.1016/j.jneb.2011.06.010. Epub 2011 Dec 8.

    PMID: 22154130BACKGROUND
  • Nonnemaker, J., Farrelly, M., Kamyab, K., Busey, A., & Mann, N. (2010). Experimental study of graphic cigarette warning labels. Final Results Report. RTI Project, 7. Accessed March 20, 2018. Available at: http://www.tobaccolabels.ca/wp/wp-content/uploads/2013/12/USA-2010-Experimental-Study-of-Graphic-Cigarette-Warning-Labels-Final-Results-Report-and-Appendices-FDA.pdf

    BACKGROUND
  • Moodie C, MacKintosh AM, Hammond D. Adolescents' response to text-only tobacco health warnings: results from the 2008 UK Youth Tobacco Policy Survey. Eur J Public Health. 2010 Aug;20(4):463-9. doi: 10.1093/eurpub/ckp199. Epub 2009 Dec 3.

    PMID: 19959613BACKGROUND
  • Klein WM, Zajac LE, Monin MM. Worry as a moderator of the association between risk perceptions and quitting intentions in young adult and adult smokers. Ann Behav Med. 2009 Dec;38(3):256-61. doi: 10.1007/s12160-009-9143-2.

    PMID: 20049660BACKGROUND
  • Fathelrahman AI, Omar M, Awang R, Cummings KM, Borland R, Bin Mohd Samin AS. Impact of the new Malaysian cigarette pack warnings on smokers' awareness of health risks and interest in quitting smoking. Int J Environ Res Public Health. 2010 Nov;7(11):4089-99. doi: 10.3390/ijerph7114089. Epub 2010 Nov 22.

    PMID: 21139879BACKGROUND
  • Brewer NT, Jeong M, Mendel JR, Hall MG, Zhang D, Parada H Jr, Boynton MH, Noar SM, Baig SA, Morgan JC, Ribisl KM. Cigarette pack messages about toxic chemicals: a randomised clinical trial. Tob Control. 2019 Jan;28(1):74-80. doi: 10.1136/tobaccocontrol-2017-054112. Epub 2018 Apr 13.

    PMID: 29654122BACKGROUND
  • Grummon AH, Taillie LS, Golden SD, Hall MG, Ranney LM, Brewer NT. Sugar-Sweetened Beverage Health Warnings and Purchases: A Randomized Controlled Trial. Am J Prev Med. 2019 Nov;57(5):601-610. doi: 10.1016/j.amepre.2019.06.019. Epub 2019 Oct 2.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Results Point of Contact

Title
Anna Grummon, PhD
Organization
University of North Carolina at Chapel Hill

Study Officials

  • Anna H Grummon, MSPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This trial uses incomplete disclosure to mask the purpose of the trial from participants.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2018

First Posted

April 30, 2018

Study Start

May 11, 2018

Primary Completion

September 19, 2018

Study Completion

September 19, 2018

Last Updated

March 30, 2021

Results First Posted

March 10, 2021

Record last verified: 2021-03

Locations