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Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction

Primary Purpose

Food Preferences

Status
Completed
Phase
Phase 3
Locations
Guatemala
Study Type
Interventional
Intervention
Exposure to beverage health information
Exposure to beverage calorie information
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Food Preferences focused on measuring Food Labeling, Adolescents

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universidad Rafael Landivar

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

No Intervention

No Intervention

Arm Label

Calorie/Control Poster

SSB Warning and Non-SSB Promotion Poster

Baseline for Calorie/Control Poster

Baseline for SSB Warning and Non-SSB Promotion Poster

Arm Description

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.

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.

We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.

We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.

Outcomes

Primary Outcome Measures

Volume of SSBs Per Transaction
Total milliliters of SSBs per transaction from sales data
Beverage Calories Per Transaction
Total number of calories for all beverages (SSBs and non-SSBs) per transaction from sales data

Secondary Outcome Measures

Total Calories Per Transaction
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)

Full Information

First Posted
July 9, 2019
Last Updated
March 1, 2021
Sponsor
University of Pennsylvania
Collaborators
Fogarty International Center of the National Institute of Health, Universidad Rafael Landivar
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1. Study Identification

Unique Protocol Identification Number
NCT04022694
Brief Title
Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction
Official Title
Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Fogarty International Center of the National Institute of Health, Universidad Rafael Landivar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Preferences
Keywords
Food Labeling, Adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Three private schools will be enrolled in the study (two larger, one smaller) that have students between the ages of 12 and 18. There will be no posters displayed at any of the schools during the baseline period. The two larger schools will be randomized to either an SSB warning/non-SSB promoting poster or a calorie/control poster that will be implemented in the school cafeterias during a four-week intervention period. To increase the sample size for the intervention condition, the intervention will also be implemented at a smaller school. For the primary analysis, data only from schools that were randomized to condition will be used. Data was collected from both a sample of participants & from the cash registers directly.
Masking
None (Open Label)
Masking Description
Participants will be told the researchers are interested in cafeteria purchase preferences, but participants will not know which condition has been assigned to individual participants.
Allocation
Randomized
Enrollment
628 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calorie/Control Poster
Arm Type
Active Comparator
Arm Description
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.
Arm Title
SSB Warning and Non-SSB Promotion Poster
Arm Type
Experimental
Arm Description
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.
Arm Title
Baseline for Calorie/Control Poster
Arm Type
No Intervention
Arm Description
We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.
Arm Title
Baseline for SSB Warning and Non-SSB Promotion Poster
Arm Type
No Intervention
Arm Description
We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.
Intervention Type
Behavioral
Intervention Name(s)
Exposure to beverage health information
Intervention Description
Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information
Intervention Type
Behavioral
Intervention Name(s)
Exposure to beverage calorie information
Intervention Description
Calories for sugar-sweetened and non-sugar-sweetened beverages
Primary Outcome Measure Information:
Title
Volume of SSBs Per Transaction
Description
Total milliliters of SSBs per transaction from sales data
Time Frame
Through study period (either 4 weeks baseline, or 4 weeks intervention)
Title
Beverage Calories Per Transaction
Description
Total number of calories for all beverages (SSBs and non-SSBs) per transaction from sales data
Time Frame
Through study period (either 4 weeks baseline or 4 weeks intervention)
Secondary Outcome Measure Information:
Title
Total Calories Per Transaction
Description
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)
Time Frame
Through time frame (either 4 weeks baseline, or 4 weeks intervention)
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Transactions With SSBs Out of All Food and Beverage Transactions
Description
Percentage of participants with transactions that have sugar sweetened beverages out of all participants who had food and beverage transactions
Time Frame
4-week baseline and 4-week intervention
Title
Percentage of Participants With Transactions With SSBs Out of All Beverage Transactions
Description
Percentage of participants with transactions that have sugar sweetened beverages out of all participants who had beverage transactions
Time Frame
4-week baseline and 4-week intervention
Title
Unhealthy Perceptions of SSBs
Description
Average of perceptions of healthiness (measured on Likert scales) for two items (1=Extremely unhealthy; 7=Extremely healthy, lower values are more accurate)
Time Frame
4 weeks baseline, 4 weeks intervention
Title
Healthy Perceptions of Non-SSBs
Description
Average of perceptions of healthiness (measured on Likert scales) for two items (1=Extremely unhealthy; 7=Extremely healthy, higher values are more accurate)
Time Frame
4 weeks baseline, 4 weeks intervention
Title
Perceived Influence of Poster Among Those Who Saw it
Description
"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)
Time Frame
During intervention, 4 weeks
Title
Poster Message Trust
Description
"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)
Time Frame
During intervention, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina A Roberto, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Rafael Landivar
City
Guatemala City
Country
Guatemala

12. IPD Sharing Statement

Plan to Share IPD
No

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Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction

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