NCT04637412

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,448

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2020

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

November 16, 2020

Last Update Submit

January 6, 2021

Conditions

Keywords

Added SugarsHealth messaging

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

Control label

EXPERIMENTAL

Participant will see a QR code and footnote saying, "Scan the QR code for more menu information." The label will be applied to all menu items displayed.

Other: Menu label

Icon plus text added sugars label

EXPERIMENTAL

Participant will see a label containing an icon plus text label with an explanatory footnote. The label will be applied to items high in added sugars (exceeding half the daily value). Participants will randomly view one of 18 variations of icons and text in this arm.

Other: Menu label

Icon only added sugars label

EXPERIMENTAL

Participant will see a label containing an icon only with an explanatory footnote. The label will be applied to items high in added sugars (exceeding half the daily value). Participants will randomly view one of 6 variations of icons in this arm.

Other: Menu label

Interventions

Participants will be shown a sample of items from a restaurant menu, displayed with labels

Control labelIcon only added sugars labelIcon plus text added sugars label

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

Location

Related Publications (2)

  • 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.

    PMID: 30321252BACKGROUND
  • Sigala DM, Hall MG, Musicus AA, Roberto CA, Solar SE, Fan S, Sorscher S, Nara D, Falbe J. Perceived effectiveness of added-sugar warning label designs for U.S. restaurant menus: An online randomized controlled trial. Prev Med. 2022 Jul;160:107090. doi: 10.1016/j.ypmed.2022.107090. Epub 2022 May 17.

Study Officials

  • Jennifer Falbe, ScD, MPH

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study uses both a between- and within-subjects design. Between-subjects design: Participants will be randomized to view restaurant menu items with a control label (QR code) or either one of two added sugars labels: an icon based label or the same icon plus text. (Within the icon condition, participants will be randomized to view 1 of 6 label icons. In the icon plus text condition, participants will be randomized to see 1 of 3 text options accompanying 1 of the 6 icons. Within-subjects design: To identify which label is perceived as most discouraging, participants will view the 3 labels one-by-one in random order, for a total of 3 conditions. To identify which design variations in icon and text are perceived as most discouraging, participants will view 6 icon-only labels one-by-one in random order. Then participants will view each of the 3 text variations together with one of the icons one-by-one in random order.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 19, 2020

Study Start

November 13, 2020

Primary Completion

December 26, 2020

Study Completion

December 26, 2020

Last Updated

January 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations