- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06842693
Testing Non-nutritive Sweetener Labels in Chile
Evaluating Chile's Proposed Non-nutritive Sweeteners Warning Label Regulation
The goal of this experiment is to examine the effects of 2 types of non-nutritive sweetener (NNS) warning labels among a sample of Chilean parents. The main questions this experiment aims to answer are:
Do non-nutritive sweetener warning labels improve consumers' ability to identify when a product contains non-nutritive sweeteners?
Do non-nutritive sweetener warning labels impact on consumers' selection of non-nutritive sweetener-sweetened, unsweetened, and/or sugar-sweetened products for their children?
Participants will be randomly assigned to 1 of 3 types of labels and view their assigned label on 3 sets of products. Each set will display 4 similar products: one unsweetened, one sweetened with sugar, one sweetened with non-nutritive sweeteners, and one sweetened with both sugar and non-nutritive sweeteners. For each set, participants will identify which product(s) contain NNS and select the product that they would purchase for their child. Researchers will compare results across label types.
Study Overview
Status
Conditions
Detailed Description
Participants will complete an online randomized experiment programmed in Qualtrics. After providing informed consent, participants will be randomly assigned to view 1 of 3 types of labels: a neutral control label, a rectangular label stating "contains non-nutritive sweeteners, not recommended for children" (i.e., Chilean NNS label), or an octagonal label stating "contains non-nutritive sweeteners" (i.e., Colombian NNS label).
Participants will view their assigned label on 4 similar products (one unsweetened, one sweetened with sugar, one sweetened with non-nutritive sweeteners, and one sweetened with both sugar and non-nutritive sweeteners) displayed in random order and complete a task where they identify which product(s) contain non-nutritive sweeteners and select one of the products to purchase for their child. During this task, in all arms, products will also display Chile's current nutrient warning labels when applicable. This task will be repeated 3 times, each time with a different product category (i.e., fruit drinks, yogurts, breakfast cereals), with categories displayed in random order.
After the selection/identification tasks, participants will view their assigned labels on 2 products containing non-nutritive sweeteners (i.e., flavored milk and cereal bar). For each product, participants will rate the perceived message effectiveness of the label and perceived product healthfulness. Lastly, after all product exposures, participants will rate their intentions to limit their child's non-nutritive sweetener consumption.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27599
- The University of North Carolina at Chapel Hill's Gillings School of Global Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years or older
- Parent or guardian of child between 2-14 years old who has never been diagnosed with diabetes, high blood sugar, pre-diabetes or insulin resistance
- Residing in Chile
Exclusion Criteria:
- Less than 18 years old
- Not parent or guardian of child between 2-14 years old who has never been diagnosed with diabetes, high blood sugar, pre-diabetes or insulin resistance
- Not residing in Chile
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
|
Products carry neutral control label when containing non-nutritive sweeteners.
Additionally, to match the current Chilean legislation, products carry an octagonal label that states "high in sugar" when high in added sugars, and/or an octagonal label that states "high in calories" when high in calorie density.
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Experimental: Chilean non-nutritive sweetener label
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Products carry rectangular label that states "contains non-nutritive sweeteners, not recommended for children" when containing non-nutritive sweeteners.
Additionally, to match the current Chilean legislation, products carry an octagonal label that states "high in sugar" when high in added sugars, and/or an octagonal label that states "high in calories" when high in calorie density.
|
|
Experimental: Colombian non-nutritive sweetener label
|
Products carry octagonal label that states "contains non-nutritive sweeteners " when containing non-nutritive sweeteners.
Additionally, to match the current Chilean legislation, products carry an octagonal label that states "high in sugar" when high in added sugars, and/or an octagonal label that states "high in calories" when high in calorie density.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correct identification of non-nutritive sweetener containing products
Time Frame: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
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Correct identification of products that contain non-nutritive sweeteners will be measured by survey.
Response will be coded in a dichotomous 0-1 range, where 1 indicates that the participant correctly identified the products that contained non-nutritive sweeteners and 0 indicates that the participant did not correctly identify the products that contained non-nutritive sweeteners.
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During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
|
|
Selection of non-nutritive sweetener-sweetened product for purchase
Time Frame: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
|
Selection of sugar-sweetened product for purchase will be measured by survey.
Response will be coded in a dichotomous 0-1 range, where 1 indicates that the participant chose one of the non-nutritive sweetener-sweetened products and 0 indicates that the participants selected one of the other two products.
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During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
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|
Selection of unsweetened product for purchase
Time Frame: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
|
Selection of unsweetened product for purchase will be measured by survey.
Response will be coded in a dichotomous 0-1 range, where 1 indicates that the participant chose the unsweetened product and 0 indicates that the participants selected one of the other three products.
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During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
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Selection of sugar-sweetened product for purchase
Time Frame: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
|
Selection of sugar-sweetened product for purchase will be measured by survey.
Response will be coded in a dichotomous 0-1 range, where 1 indicates that the participant chose one of the sugar-sweetened products and 0 indicates that the participants selected one of the other two products.
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During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived message effectiveness, mean score
Time Frame: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
|
Perceived message effectiveness will be measured by survey through a three-item scale.
Items will inquire about how much participants perceive the label to (1) discourage them from wanting to buy products with non-nutritive sweeteners for their child, (2) makes them concerned about the health effects of their child consuming products with non-nutritive sweeteners, and (3) makes buying products with non-nutritive sweeteners for their child seem unpleasant to them.
Response options will be on a 5-point scale between "not at all" (coded as 1) and "very much" (coded as 5), with higher scores representing a higher perceived message effectiveness.
Each participant's responses to each item will be combined to obtain their final score on the outcome.
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During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
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Perceived product healthfulness, mean score
Time Frame: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
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How good or bad for participants' children it would be to consume the product every day will be measured by survey.
Response options will be on a 5-point scale between "very bad" (coded as 1) and "very good" (coded as 5), with higher scores representing a higher perceived product healthfulness.
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During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
|
|
Intentions to limit non-nutritive sweetener consumption, mean score
Time Frame: After exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
|
How much participants intend to limit their child's consumption of non-nutritive sweeteners in the next week will be measured by survey.
Response options will be on a 5-point scale between "not at all" (coded as 1) and "very much" (coded as 5), with higher scores representing a higher intention to limit consumption.
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After exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
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Relative product healthfulness, mean score
Time Frame: During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
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How healthy participants perceive the non-nutritive sweetener-containing product to be compared to the version of the product that contains added sugars will be measured by survey.
Response options will be on a 5-point scale between "much less healthy" (coded as 1) and "much healthier" (coded as 5), with higher scores representing a higher comparative product healthfulness.
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During exposure to intervention (i.e., study stimuli), assessed during one-time online 10-minute survey.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lindsey Smith Taillie, PhD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 24-2896a
- 24-2205 (Other Grant/Funding Number: Bloomberg Philanthropies)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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