- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07528443
Ultraprocessed Foods in Colombia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will employ a 2x2 between-subjects experimental design to investigate the independent and combined effects of characters and front-of-package warning labels on children's risk perceptions, purchase intentions and perceived message effectiveness regarding ultra-processed foods.
After parents or legal guardians provide informed consent and the children assent to participate, the survey platform (Qualtrics) will randomly assign each child to one of four experimental conditions:
- Warning label + Character
- Warning label only
- Barcode control label + Character
- Barcode control label only
Participants will complete the study online through a self-administered survey programmed in Qualtrics. This survey has a duration of approximately 15 minutes. Each child will be exposed to three fictional ultra-processed food products (cookies package, juice bottle, and chip bag), displayed in random order. The stimuli were developed to resemble common products in Colombia but without using real brands to avoid brand loyalty bias. Each product will be displayed with a label consistent with the child's assigned experimental condition.
Children will respond to a series of questions for each product individually. These questions will assess:
- Risk perception
- Purchase intention
- Perceived message effectiveness
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria Parra-Murillo
- Phone Number: 9843220948
- Email: mparram@unc.edu
Study Locations
-
-
-
Bogotá, Colombia
- Online panel
-
Contact:
- Luis F Gómez
- Phone Number: (+57) 601 320 8320 Ext. 2843
- Email: l.gomezg@javeriana.edu.co
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Principal Investigator:
- Luis Fernando Gómez Guitierrez, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children and adolescents between 12 and 17 years old
- Colombian residents
Exclusion Criteria:
- Children with legal blindness, partial blindness, or total blindness, since the study involves viewing images and reading questions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Warning label + Character
|
Participants will view images of three products containing octagonal warning labels.
Participants will view images of three products containing characters.
|
|
Experimental: Barcode control label + Character
|
Participants will view images of three products containing characters.
Participants will view images of three products containing Barcode control label.
|
|
Experimental: Warning label only
|
Participants will view images of three products containing octagonal warning labels.
Participants will view images of three products without characters.
|
|
Other: Barcode control label only
|
Participants will view images of three products containing Barcode control label.
Participants will view images of three products without characters.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Purchase intention
Time Frame: During ~15 minute online survey
|
Purchase intention will be assessed using 1 item: "How likely are you to consume this product?"
Responses will be recorded on a 5-point Likert-style scale ranging from 1 ("Not at all likely") to 5 ("Very likely").
Because this is a single-item measure, the total score ranges from 1 to 5. Higher scores indicate greater purchase intention, whereas lower scores indicate lower purchase intention.
|
During ~15 minute online survey
|
|
Risk perception
Time Frame: During ~15 minute online survey
|
Risk perception will be assessed using 1 item: "How healthy do you think this product is?" Responses will be recorded on a 5-point Likert-style scale ranging from 1 ("Not healthy at all") to 5 ("Very healthy").
Because this is a single-item measure, the total score ranges from 1 to 5. Higher scores indicate that the product is perceived as healthier (i.e., lower perceived risk), whereas lower scores indicate that the product is perceived as less healthy (i.e., higher perceived risk).
|
During ~15 minute online survey
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Message Effectiveness
Time Frame: During ~15 minute online survey
|
Perceived message effectiveness will be assessed using 3 items, each measured on a 5-point Likert-style scale (1-5): "How much does this label make you worry about what consuming this product will do to you?" (1 = Not at all worried; 5 = Extremely worried) "How much does this label make you think consuming this product is a bad idea?" (1 = Makes me think it's a very good idea to consume it; 5 = Makes me think it's a very bad idea to consume it) "How much does this label discourage you from consuming this product?" (1 = Doesn't discourage me at all; 5 = Completely discourages me) For each product evaluated, a perceived message effectiveness score will be calculated as the mean of the 3 items, resulting in a score ranging from 1 to 5. Higher scores indicate greater perceived message effectiveness, whereas lower scores indicate lower perceived message effectiveness. |
During ~15 minute online survey
|
Collaborators and Investigators
Investigators
- Principal Investigator: Maria Parra-Murillo, University of North Carolina, Chapel Hill
- Study Director: Marissa Hall, PhD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-2935
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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