Perceived Effectiveness of Added Sugar Labels

Attitude to Health Clinical Trial

Official title:

Perceived Effectiveness of Added Sugar Labels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637412
• Other study ID #: 1641776
• Status: Completed
• Phase: N/A
• Start date: November 13, 2020
• Est. completion date: December 26, 2020

Study information

• Verified date: January 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to develop a restaurant menu label to indicate foods and beverage items on restaurant menus that contain high amounts of added sugars and to test its perceived effectiveness.

Description:

Objectives and hypotheses:

The goal of this study is to examine how added sugar restaurant menu labels influence U.S. adults' perceptions and reactions. Predictions:

In a between-subjects experiment with 3 arms (control label, icon-only added sugars label, and icon plus text added sugars label):

1. Added sugar labels will be perceived as more effective than the control label.

2. The text plus icon label will be perceived as more effective than the icon-only label.

3. A larger proportion of participants who see the added sugar labels will report learning something new than those who see the control label.

4. Added sugar labels will lead participants to more accurately identify restaurant menu items high in added sugars compared to the control label, and the text plus icon label will outperform the icon-only label on this outcome.

Additionally, using a within-subjects design:

The study will examine which label (control, icon, text plus icon) most discourages wanting to consume menu items high in added sugars.

Analyses will compare various icon and text options for the added sugars label to determine which icon and which text variations are perceived as most discouraging for wanting to consume items high in added sugars. The is no hypothesis about which will be perceived as more discouraging.

Planned analyses:

For predictions 1-2: linear regression model (OLS) regressing PME on indicator variables for experimental condition. The margins command in STATA will be used to conduct pairwise comparisons between each condition (i.e., icon-only vs. icon plus text label). Also, PME will be regressed on an indicator variable combining the added sugar label groups.

For predictions 3-4, Poisson regression with robust standard errors will be used to estimate relative probability, regressing each dichotomous outcome on indicator variables for experimental condition. The margins command in STATA will be used to conduct pairwise comparisons between each condition. The outcomes will be regressed on an indicator variable combining the added sugar label groups. If the Poisson regressions do not converge, logistic regression will be used.

For the within-subjects comparisons, mixed effects linear models will be used to assess the relationship between condition and rating of label discouragement for consuming items high in added sugars.

A critical alpha 0.05 will be used, and statistical tests will be two-tailed. Because this is an initial, exploratory study to help identify the best performing label to use in a larger trial, alpha level will not be adjusted to control for multiple comparisons.

If there is evidence of deviations from modeling assumptions required for the parametric tests above, non-parametric sensitivity analyses will be conducted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1448
• Est. completion date: December 26, 2020
• Est. primary completion date: December 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Equal or greater than 18 years of age

• Less than 100 years of age

• English-speaking

• U.S. residents

• Had to have purchased food from a restaurant at least once per month prior to the COVID-19 pandemic

• Participants will reflect the U.S. Census Bureau's 2018 American Community Survey 5-year estimates for gender, race/ethnicity, educational attainment, and age

Exclusion criteria:

• Failing the attention check question

• Completing the survey in less than 30% of the median completion time

• Straightlining

• Providing nonsensical responses to open-ended questions

Related Conditions & MeSH terms

• Attitude to Health
• Health Knowledge

Intervention

Other:
• Menu label
Participants will be shown a sample of items from a restaurant menu, displayed with labels

Locations

Country	Name	City	State
United States	University of California, Davis	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Center for Science in the Public Interest (CSPI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Baig SA, Noar SM, Gottfredson NC, Boynton MH, Ribisl KM, Brewer NT. UNC Perceived Message Effectiveness: Validation of a Brief Scale. Ann Behav Med. 2019 Jul 17;53(8):732-742. doi: 10.1093/abm/kay080. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived message effectiveness (PME)	Measured using 3 items adapted from Baig et al. (2018): scale 1-5, "This label makes me concerned about the health effects of consuming menu items high in added sugars", "This label makes consuming menu items high in added sugars seem unpleasant", "This label discourages me from wanting to consume menu items high in added sugars." This outcome is for the between-subjects experiment.	Up to approximately 5 minutes
Primary	Perception of how discouraging the label is for wanting to consume items high in added sugars	Based on a single item adapted from Baig et al. (2018): "This label discourages me from wanting to consume menu items high in added sugar" (scale 1-5). This outcome is the within-subjects objectives.	Up to approximately 7 minutes
Primary	Perception of knowledge gain	Dichotomous response (yes/no) to the question, "Did you learn something new from this label?" This outcome is for the between-subjects experiment.	Up to approximately 1 minute
Primary	Correct identification of items high in added sugars	"Now please look at the menu items below, and select all the ones you think have more than half the daily value for added sugars" with 8 possible responses. A dichotomous outcome variable based on the distribution of correct answers in the sample will be created. This outcome is for the between-subjects experiment.	Up to approximately 2 minutes