Clinical trial NCT05563181: Evaluation of a Beverage Media Campaign and Added-sugar Warning Labels
Official title: Evaluation of a Beverage Media Campaign and Added-sugar Warning Labels Among Latinx Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attitude
Intention
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 2003
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to examine differences in intentions (measured by hypothetical beverage selection) between the following conditions: (1) Control condition: Viewing beverages with a barcode, (2) viewing beverages that have an icon-plus-text warning label, "WARNING: High in added sugar", (3) viewing a campaign message about warning labels in one's preferred language + viewing beverages with a barcode, and (4) viewing a campaign message about warning labels in one's preferred language + viewing beverages with the warning label above. An additional objective is to compare other message reactions and perceptions and perceptions of SSBs (sugar-sweetened beverages) between the conditions. This study will use an online randomized controlled trial among Latino/a/x adults to assign participants to one of the above conditions.

Detailed description: The primary objective of this study is to examine differences in intentions (measured by hypothetical beverage selection) between the following conditions: (1) Control condition: Viewing beverages with a barcode, (2) viewing beverages that have an icon-plus-text warning label, "WARNING: High in added sugar", (3) viewing a campaign message about warning labels in one's preferred language + viewing beverages with a barcode, and (4) viewing a campaign message about warning labels in one's preferred language + viewing beverages with the warning label above. An additional objective is to compare other message reactions and perceptions and perceptions of SSBs (sugar-sweetened beverages) between the conditions. This study will use an online randomized controlled trial among Latino/a/x adults to assign participants to one of the above conditions. Although this study uses prospective assignment, it is not a clinical trial because the outcomes are intentions, attitudes, and other reactions and perceptions and not behavioral or health outcomes.

Participants can take the survey in English or Spanish, but the warning labels on the beverages will always be in English. In the campaign conditions, if the participant generally speaks and reads in Spanish better than English, they will be shown the campaign message in Spanish, and otherwise, they will be shown the campaign message in English.

Within the campaign conditions, participants will be randomized to view 1 of 3 campaign posters that have different messages. Also, at the end of the questionnaire, all participants will be shown 1 of the 3 campaign message posters and asked to provide ratings of perceived discouragement (one of the 3 PME questions), how much the poster grabs attention, and how trustworthy the poster is. Following that item, all participants will view all 3 posters one after the other on the same page (shown in random order) and asked to select the one that discourages them the most from wanting to drink beverages high in added sugar.

1. Primary outcome: hypothetical selection of a sugar-sweetened beverage (SSB) for oneself.

   Analysis will use Poisson regression with robust standard errors, regressing dichotomous selection of an SSB on indicators for condition, which are described below:
   1. Main effects: Indicators for the warning label condition and campaign poster condition.
   2. To examine interaction effects: Indicators for warning label condition and campaign poster condition as well as a label by campaign interaction term.
2. Secondary outcomes: For binary outcomes, the analysis will entail the same modeling approach as above, and for continuous outcomes, the analysis will use linear regression models with the same indicators in the model. For outcomes about campaign posters, instead of including indicators for condition in the model, the analysis will include indicators for type of poster. For the question that asks participants to select the 1 poster (out of 3) that most discourages consumption, the analysis will use a chi-square goodness of fit test to see if the proportion of participants selecting any one poster differs significantly than what would be expected by chance. That model will include indicators for experimental condition. Within family of outcomes, the Holm-Bonferroni procedure will be used to adjust for multiple comparisons.

Exploratory analyses:

1. For the outcome of hypothetical selection of an SSB for one's child, the same modeling approach as specified for the primary outcome will be used.
2. Exploration of effect modification will be examined in separate models using interaction terms between condition and indicators for levels of the following characteristics: Participant reported speaking and reading better in Spanish than English, cut-points on the Short Acculturation Scale for Hispanics (SASH), household income and poverty level, gender, and educational attainment.

Eligibility criteria: Inclusion Criteria:

* Identifying as Latino/a/x
* Residing within the United States and U.S. territories
* Age 18+

Two panel companies will be used to recruit participants. To maximize recruitment of participants who prefer Spanish over English, through one of the panel companies, eligibility will be restricted to participants reporting that Spanish was their first language and through the second panel, a quota will be used to aim for ≥50% who prefer Spanish over English. For the second panel, additional quotas will be used to maximize gender balance and inclusion of parents: ≤60 percent women, and ≥50% with a child age 2-17. Quotas may need to be adjusted to obtain desired sample size.

Exclusion Criteria for main analysis:

* Failing attention check question
* Speeding (finishing survey in \<33% of the median completion time)

Primary outcomes:
measure: Intention to purchase a sugar-sweetened beverage in a hypothetical selection task (not a scale)
timeFrame: Approximately 0.5-2 minutes
Secondary outcomes:
measure: Intention to consume sugar-sweetened beverages and water in the next 4 weeks (there is no scale title)
timeFrame: ≤20 minutes
measure: Scale title: University of North Carolina (UNC) Perceived message effectiveness (PME)
timeFrame: ≤20 minutes
measure: Noticing the label (not a scale)
timeFrame: ≤20 minutes
measure: Outcome expectations re: sugar-sweetened beverages increasing risk of type 2 diabetes, heart disease, and tooth decay (there is no scale title)
timeFrame: ≤20 minutes
measure: Perception of learning something new from the label (not a scale)
timeFrame: ≤20 minutes
measure: Anticipated social interaction about the label (there is no scale title)
timeFrame: ≤20 minutes
measure: Support for policy requiring labels (there is no scale title)
timeFrame: ≤20 minutes
measure: Reactions to poster: Perception that informational campaign poster discourages consumption of beverages high in added sugar (adapted item from the UNC PME Scale), grabs attention (no scale title), and is trustworthy (no scale title)
timeFrame: ≤20 minutes
measure: Selection of informational campaign that most discourages consumption of beverages high in added sugar (not an scale)
timeFrame: ≤20 minutes
Other outcomes:
measure: Intention to purchase a sugar-sweetened beverage for one's child under the age of 18 in a hypothetical selection task (not a scale)
timeFrame: Approximately 0.5-2 minutes
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: UC Davis
name: Jennifer Falbe
role: PRINCIPAL_INVESTIGATOR
References: