Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction

Food Preferences Clinical Trial

Official title:

Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04022694
• Other study ID #: R21TW010837
• Secondary ID: R21TW010837
• Status: Completed
• Phase: Phase 3
• Start date: July 8, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: March 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Preferences
• Noncommunicable Diseases

Intervention

Behavioral:
• Exposure to beverage health information
Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information
• Exposure to beverage calorie information
Calories for sugar-sweetened and non-sugar-sweetened beverages

Locations

Country	Name	City	State
Guatemala	Universidad Rafael Landivar	Guatemala City

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	Fogarty International Center of the National Institute of Health, Universidad Rafael Landivar

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Transactions With SSBs Out of All Food and Beverage Transactions	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
Other	Percentage of Participants With Transactions With SSBs Out of All Beverage Transactions	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
Other	Unhealthy Perceptions of SSBs	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
Other	Healthy Perceptions of Non-SSBs	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
Other	Perceived Influence of Poster Among Those Who Saw it	"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
Other	Poster Message Trust	"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
Primary	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)
Primary	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	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)	Through time frame (either 4 weeks baseline, or 4 weeks intervention)