Clinical trial NCT04022694: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Food Preferences
Keywords: Food Labeling
Adolescents
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
name: Universidad Rafael Landivar
First posted: 2019-07-17
Enrollment: 628
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Volume of SSBs Per Transaction
timeFrame: Through study period (either 4 weeks baseline, or 4 weeks intervention)
measure: Beverage Calories Per Transaction
timeFrame: Through study period (either 4 weeks baseline or 4 weeks intervention)
Secondary outcomes:
measure: Total Calories Per Transaction
timeFrame: Through time frame (either 4 weeks baseline, or 4 weeks intervention)
Other outcomes:
measure: Percentage of Participants With Transactions With SSBs Out of All Food and Beverage Transactions
timeFrame: 4-week baseline and 4-week intervention
measure: Percentage of Participants With Transactions With SSBs Out of All Beverage Transactions
timeFrame: 4-week baseline and 4-week intervention
measure: Unhealthy Perceptions of SSBs
timeFrame: 4 weeks baseline, 4 weeks intervention
measure: Healthy Perceptions of Non-SSBs
timeFrame: 4 weeks baseline, 4 weeks intervention
measure: Perceived Influence of Poster Among Those Who Saw it
timeFrame: During intervention, 4 weeks
measure: Poster Message Trust
timeFrame: During intervention, 4 weeks
Locations:
city: Guatemala City
country: Guatemala
facility: Universidad Rafael Landivar
Study officials:
affiliation: University of Pennsylvania
name: Christina A Roberto, PhD
role: PRINCIPAL_INVESTIGATOR
References: