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ObesityNCT05783726

Testing Product Messages in Colombia

A study testing Nutriscore Label, Adapted Peruvian Nutrient Label and Guideline Daily Amount Label in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose: To better understand the impact of different front-of-package labels (FOPLs) on consumer purchasing intentions and ability to identify unhealthy foods. Participants: ~8,000 Colombians, recruited from Offerwise, that are 18 years or older. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Nutriscore Label, Adapted Peruvian Nutrient Label and Guideline Daily Amount Label
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8,086 participants
Where
1 siteUnited States
Study dates
12 May 2023to 22 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18-64 years old
  • Resident of Colombia
  • Offerwise panel member (recruitment platform)

Who cannot join

  • <18 years old or >64 years old
  • Not a resident of Colombia

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UNC Carolina Population Center

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Purpose: To better understand the impact of different front-of-package labels (FOPLs) on consumer purchasing intentions and ability to identify unhealthy foods.

Participants: ~8,000 Colombians, recruited from Offerwise, that are 18 years or older.

Procedures (methods): Participants will be randomly assigned to view images of food and drink products with either a nutrient warning label, Guideline Daily Amount label, Nutriscore label, or no-label control. They will be asked a series of questions about the products and the labels (excluding control group) on them. Questions will also include standard demographic and health related variables.

Read the detailed description

Participants will be recruited from Offerwise (an online panel research company). Following online consent, participants will be randomly assigned to view different labels (explained below) on food and drink packaging. Participants will answer self-reported responses to the content (e.g., elaboration, beliefs, perceived healthfulness). After being randomized to one of the four groups and answering questions (e.g. which product is healthier, which product would you buy), the participant will see all three labels and select which is most dissuading from consuming a product high in a nutrient. At the end, the participant will answer demographic questions.

Participants will be randomized to see either a no-label control or 1 of 3 nutrient labels. The participants will see 5 types of products with the labels (fruit drinks, yogurt, sliced bread, cookies, and breakfast cereal).

Nutrient labels:

  1. Guideline Daily Amount label
  2. Nutriscore label
  3. Adapted Peruvian nutrient warning label (high in sugar, high in saturated fat, high in salt/sodium)
Conditions
Obesity
Being tested
Control, Nutriscore Label, Adapted Peruvian Nutrient Label, Guideline Daily Amount Label
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ControlOther

    Participants will be shown images of juice, bread, yogurt, cookies, and cereal without any added front-of-package labels.

  • Nutriscore LabelBehavioural

    A front-of-package Nutriscore label will be applied to images of juice, bread, yogurt, cookies, and cereal. This label applies a score of A, B, C, D, or E based on the product's nutrition profile.

  • Adapted Peruvian Nutrient LabelBehavioural

    A front-of-package octagonal nutrient label will be applied to images of juice, bread, yogurt, cookies, and cereal. The label text informs consumers if a product is high in sugar, saturated fat, or salt/sodium. These labels were developed by the Peruvian government and adapted by investigators.

  • Guideline Daily Amount LabelBehavioural

    A front-of-package Guideline Daily Amount label will be applied to images of juice, bread, yogurt, cookies, and cereal. The label shows the amount and percent of daily value of calories, total fat, saturated fat, sugar, and sodium in one serving of a product.

Study groups in NCT05783726
Study groupRoleWhat they receive
ControlOtherThe control arm will show the products with no label.
Receives: Other: Control
Experimental: Nutriscore LabelExperimentalThe Nutriscore label applies a letter grade (A, B, C, D or E) to a product based on certain nutrient criteria.
Receives: Behavioral: Nutriscore Label
Experimental: Adapted Peruvian Nutrient LabelExperimentalThe adapted label is a black octagon with the words in Spanish saying "Excess of sugar,"Excess of saturated fat," or "Excess of salt/sodium" depending on the nutrition contents of the product. Below the octagon is a box with words in Spanish saying "Avoid high consumption"
Receives: Behavioral: Adapted Peruvian Nutrient Label
Experimental: Guideline Daily Amount LabelExperimentalThe Guideline Daily Amount label highlights the nutrient contents of the product by serving. It lists the calories, total fat, saturated fat, sugar, and sodium, as well are their % of the daily value.
Receives: Behavioral: Guideline Daily Amount Label

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Selection of Product Higher in Sugar

    Percentage of participants who select the less healthy product in a set of two products as the product the consumer most wants to buy.

    Measured: During ~15 minute online survey

  2. Correct Identification of the Product Higher in Sugar

    Percentage of participants who correctly select the product higher in sugar (between two products)

    Measured: During ~15 minute online survey

Secondary outcomes (5)

  1. Perceived Message Effectiveness

    Perceived message effectiveness of the study labels. Response options are on a 1 to 5 scale, with lower scores representing a higher amount of the construct.

    Perceived message effectiveness is measured using 3 items adapted from Baig et al. (2018): concern, unpleasantness, and discouragement. Responses to the 3 items will be averaged to create a perceived message effectiveness score.

    Question: How much does this message...

    make you concerned about the health effect of consuming an unhealthy product? discourage you from wanting to eat an unhealthy product? make eating an unhealthy product seem unpleasant to you? Only asked of the label arms, not control.

    Measured: During ~15 minute online survey

  2. Purchase Likelihood

    Likelihood that participants would purchase this product in the next week if it were available. Response options are on a 1 to 5 scale, with lower scores representing a higher amount of the construct

    Measured: During ~15 minute online survey

  3. Identify Less Healthy Product

    Percentage of participants that correctly identify the less healthy product when selecting between two products.

    Measured: During ~15 minute online survey

  4. Ability to Identify Product as Having Excess of Sugar/Saturated Fat/Sodium

    Percentage of participants who correctly identify that the product contains excess sugar, saturated fat, or sodium.

    Measured: During ~15 minute online survey

  5. Most Discouraging Label

    Percentage of participants selecting each nutrient label as most discouraging them from consuming the product.

    Measured: During ~15 minute online survey

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2023
  2. Study start12 May 2023
  3. Primary completion22 Jun 2023
  4. Study completion22 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8,086 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05783726
Sponsor's protocol ID
20-0401b
Status last verified
May 2023
First submitted
13 Mar 2023
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mora-Plazas M, Higgins ICA, Gomez LF, Hall MG, Parra MF, Bercholz M, Murukutla N, Taillie LS. Impact of nutrient warning labels on Colombian consumers' selection and identification of food and drinks high in sugar, sodium, and saturated fat: A randomized controlled trial. PLoS One. 2024 Jun 10;19(6):e0303514. doi: 10.1371/journal.pone.0303514. eCollection 2024.

    PubMed 38857209

Questions about this trial

What is this clinical trial studying?

A study testing Nutriscore Label, Adapted Peruvian Nutrient Label and Guideline Daily Amount Label in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Selection of Product Higher in Sugar (time frame: During ~15 minute online survey). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05783726, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.

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Testing Product Messages in Colombia (NCT05783726) | AzTrials