Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction

March 1, 2021 updated by: University of Pennsylvania
Sugar-sweetened beverages are a significant contributor to adult and childhood obesity in Guatemala. Policies to place health warning labels on sugar-sweetened beverages are being pursued, but there is little empirical data on how such labels influence people. The primary aim of this study is to test the association between sugar-sweetened beverage (SSB) warning posters compared to control posters and change in SSBs purchased compared to baseline by adolescents shopping at school cafeterias in Guatemala City, Guatemala. The hypothesis is that posters with information warning people of the health harms associated with overconsuming SSBs and promoting low sugar beverages will be associated with greater reductions in SSB purchases compared to a control poster.

Study Overview

Study Type

Interventional

Enrollment (Actual)

628

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Guatemala City, Guatemala
        • Universidad Rafael Landivar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 12 and 18 years old
  • Made a food or beverage purchase
  • Has permission from parent or caregiver to participate
  • Has not yet completed the purchase assessment

Exclusion Criteria:

  • Under 12 or over 18 years old
  • Did not make a food or beverage purchase
  • Parent or caregiver refused to give child permission to participate
  • Already participated in the purchase assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Calorie/Control Poster
This poster will display images of both SSBs and low or no sugar beverages with calories listed below the beverages. It will simply state that those beverages are sold in the school store.
Calories for sugar-sweetened and non-sugar-sweetened beverages
EXPERIMENTAL: SSB Warning and Non-SSB Promotion Poster
This poster will display images of both SSBs and low or no sugar beverages with calories listed below the beverages. In addition, the message will state that SSBs are high in sugar and should be avoided, while low or no sugar beverages are healthier options and should be chosen.
Calories for sugar-sweetened and non-sugar-sweetened beverages
Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information
NO_INTERVENTION: Baseline for Calorie/Control Poster
We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.
NO_INTERVENTION: Baseline for SSB Warning and Non-SSB Promotion Poster
We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of SSBs Per Transaction
Time Frame: Through study period (either 4 weeks baseline, or 4 weeks intervention)
Total milliliters of SSBs per transaction from sales data
Through study period (either 4 weeks baseline, or 4 weeks intervention)
Beverage Calories Per Transaction
Time Frame: Through study period (either 4 weeks baseline or 4 weeks intervention)
Total number of calories for all beverages (SSBs and non-SSBs) per transaction from sales data
Through study period (either 4 weeks baseline or 4 weeks intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Calories Per Transaction
Time Frame: Through time frame (either 4 weeks baseline, or 4 weeks intervention)
Total number of calories for all food and beverages (SSBs and non-SSBs) per transaction from purchase assessments (e.g., calories from Coke + bag of chips)
Through time frame (either 4 weeks baseline, or 4 weeks intervention)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Transactions With SSBs Out of All Food and Beverage Transactions
Time Frame: 4-week baseline and 4-week intervention
Percentage of participants with transactions that have sugar sweetened beverages out of all participants who had food and beverage transactions
4-week baseline and 4-week intervention
Percentage of Participants With Transactions With SSBs Out of All Beverage Transactions
Time Frame: 4-week baseline and 4-week intervention
Percentage of participants with transactions that have sugar sweetened beverages out of all participants who had beverage transactions
4-week baseline and 4-week intervention
Unhealthy Perceptions of SSBs
Time Frame: 4 weeks baseline, 4 weeks intervention
Average of perceptions of healthiness (measured on Likert scales) for two items (1=Extremely unhealthy; 7=Extremely healthy, lower values are more accurate)
4 weeks baseline, 4 weeks intervention
Healthy Perceptions of Non-SSBs
Time Frame: 4 weeks baseline, 4 weeks intervention
Average of perceptions of healthiness (measured on Likert scales) for two items (1=Extremely unhealthy; 7=Extremely healthy, higher values are more accurate)
4 weeks baseline, 4 weeks intervention
Perceived Influence of Poster Among Those Who Saw it
Time Frame: During intervention, 4 weeks
"Do you think the poster influenced what you purchased?" (1=Not at all; 5=Very much, higher values in the intervention condition indicate the intervention is perceived to be effective)
During intervention, 4 weeks
Poster Message Trust
Time Frame: During intervention, 4 weeks
"How much do you trust the information on the poster?" (1=Not at all; 5=Very much, higher values in the intervention condition indicate the intervention is perceived to be trustworthy)
During intervention, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 8, 2019

Primary Completion (ACTUAL)

August 30, 2019

Study Completion (ACTUAL)

August 30, 2019

Study Registration Dates

First Submitted

July 9, 2019

First Submitted That Met QC Criteria

July 16, 2019

First Posted (ACTUAL)

July 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • R21TW010837 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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