Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction

NCT04022694 | Completed Phase 3 Results

• 1 other identifier: R21TW010837
• Study Type: interventional
• Target: 628
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Preferences

Keywords

Food Labeling; Adolescents

Outcome Measures

Primary Outcomes (2)

• Volume of SSBs Per Transaction

  Total milliliters of SSBs per transaction from sales data

  Through study period (either 4 weeks baseline, or 4 weeks intervention)

• Beverage Calories Per Transaction

  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 Outcomes (1)

• Total Calories Per Transaction

  Through time frame (either 4 weeks baseline, or 4 weeks intervention)

Other Outcomes (6)

• Percentage of Participants With Transactions With SSBs Out of All Food and Beverage Transactions

  4-week baseline and 4-week intervention

• Percentage of Participants With Transactions With SSBs Out of All Beverage Transactions

  4-week baseline and 4-week intervention

• Unhealthy Perceptions of SSBs

  4 weeks baseline, 4 weeks intervention

Study Arms (4)

Calorie/Control Poster

ACTIVE COMPARATOR

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.

Behavioral: Exposure to beverage calorie information

SSB Warning and Non-SSB Promotion Poster

EXPERIMENTAL

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.

Behavioral: Exposure to beverage health information; Behavioral: Exposure to beverage calorie information

Baseline for Calorie/Control Poster

NO INTERVENTION

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

Baseline for SSB Warning and Non-SSB Promotion Poster

NO INTERVENTION

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

Interventions

Exposure to beverage health information BEHAVIORAL

Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information

SSB Warning and Non-SSB Promotion Poster

Exposure to beverage calorie information BEHAVIORAL

Calories for sugar-sweetened and non-sugar-sweetened beverages

Calorie/Control Poster; SSB Warning and Non-SSB Promotion Poster

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Universidad Rafael Landivar: collaborator

Study Sites (1)

Universidad Rafael Landivar

Guatemala City, Guatemala

Location

MeSH Terms

Conditions

Food Preferences

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Results Point of Contact

• Title: Deputy Director of PEACH Lab
• Organization: University of Pennsylvania

thepeachlab@gmail.com

2158987093

Study Officials

• Christina A Roberto, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 17, 2019
• Study Start: July 8, 2019
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: March 25, 2021
• Results First Posted: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)