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Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction

Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04022694
Enrollment
628
Registered
2019-07-17
Start date
2019-07-08
Completion date
2019-08-30
Last updated
2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Preferences

Keywords

Food Labeling, Adolescents

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.

Interventions

BEHAVIORALExposure 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

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

Sponsors

Fogarty International Center of the National Institute of Health
CollaboratorNIH
Universidad Rafael Landivar
CollaboratorOTHER
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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.

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.

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Volume of SSBs Per TransactionThrough study period (either 4 weeks baseline, or 4 weeks intervention)Total milliliters of SSBs per transaction from sales data
Beverage Calories Per TransactionThrough 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

Secondary

MeasureTime frameDescription
Total Calories Per TransactionThrough 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)

Other

MeasureTime frameDescription
Healthy Perceptions of Non-SSBs4 weeks baseline, 4 weeks interventionAverage of perceptions of healthiness (measured on Likert scales) for two items (1=Extremely unhealthy; 7=Extremely healthy, higher values are more accurate)
Percentage of Participants With Transactions With SSBs Out of All Food and Beverage Transactions4-week baseline and 4-week interventionPercentage of participants with transactions that have sugar sweetened beverages out of all participants who had food and beverage transactions
Poster Message TrustDuring intervention, 4 weeksHow 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)
Perceived Influence of Poster Among Those Who Saw itDuring intervention, 4 weeksDo 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)
Percentage of Participants With Transactions With SSBs Out of All Beverage Transactions4-week baseline and 4-week interventionPercentage of participants with transactions that have sugar sweetened beverages out of all participants who had beverage transactions
Unhealthy Perceptions of SSBs4 weeks baseline, 4 weeks interventionAverage of perceptions of healthiness (measured on Likert scales) for two items (1=Extremely unhealthy; 7=Extremely healthy, lower values are more accurate)

Countries

Guatemala

Participant flow

Pre-assignment details

We do not report data from 166 participants collected at a 3rd smaller school because that school was assigned (not randomized) to the SSB Warning and Non-SSB Promotion Poster because of its smaller size.

Participants by arm

ArmCount
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.
167
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 treatment school.
145
Total312

Baseline characteristics

CharacteristicBaseline for SSB Warning and Non-SSB Promotion PosterTotalBaseline for Calorie/Control Poster
Age, Categorical
<=18 years
145 Participants312 Participants167 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous14.9 years
STANDARD_DEVIATION 1.4
15.1 years
STANDARD_DEVIATION 1.5
15.3 years
STANDARD_DEVIATION 1.6
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Guatemala
145 participants312 participants167 participants
Sex: Female, Male
Female
68 Participants126 Participants58 Participants
Sex: Female, Male
Male
77 Participants186 Participants109 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 1670 / 1450 / 1430 / 173
other
Total, other adverse events
0 / 1670 / 1450 / 1430 / 173
serious
Total, serious adverse events
0 / 1670 / 1450 / 1430 / 173

Outcome results

Primary

Beverage Calories Per Transaction

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)

Population: In addition to the surveys with the participants (described in the participant flow), data on total sales were collected at the register. It is not possible to know if these sales data were associated with one or more than one participant because they are at the sales item level. For the purposes of this report, the number of participants are identical to the number of items sold.

ArmMeasureValue (MEAN)Dispersion
Baseline for Calorie/Control PosterBeverage Calories Per Transaction45.1 beverage calories soldStandard Deviation 83.7
Baseline for SSB Warning and Non-SSB Promotion PosterBeverage Calories Per Transaction35.9 beverage calories soldStandard Deviation 67.1
Calorie/Control PosterBeverage Calories Per Transaction41.2 beverage calories soldStandard Deviation 75.9
SSB Warning and Non-SSB Promotion PosterBeverage Calories Per Transaction39.0 beverage calories soldStandard Deviation 69
Primary

Volume of SSBs Per Transaction

Total milliliters of SSBs per transaction from sales data

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

Population: In addition to the surveys with the participants (described in the participant flow), data on total sales were collected at the register. It is not possible to know if these sales data were associated with one or more than one participant because they are at the sales item level. For the purposes of this report, the number of participants are identical to the number of items sold.

ArmMeasureValue (MEAN)Dispersion
Baseline for Calorie/Control PosterVolume of SSBs Per Transaction116.2 mL of Sugar Sweetened Beverages purchaseStandard Deviation 212.5
Baseline for SSB Warning and Non-SSB Promotion PosterVolume of SSBs Per Transaction89.8 mL of Sugar Sweetened Beverages purchaseStandard Deviation 160.1
Calorie/Control PosterVolume of SSBs Per Transaction115.3 mL of Sugar Sweetened Beverages purchaseStandard Deviation 211.8
SSB Warning and Non-SSB Promotion PosterVolume of SSBs Per Transaction103.4 mL of Sugar Sweetened Beverages purchaseStandard Deviation 176.2
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)

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

ArmMeasureValue (MEAN)Dispersion
Baseline for Calorie/Control PosterTotal Calories Per Transaction290.8 caloriesStandard Deviation 224.2
Baseline for SSB Warning and Non-SSB Promotion PosterTotal Calories Per Transaction338.5 caloriesStandard Deviation 222.6
Calorie/Control PosterTotal Calories Per Transaction287.5 caloriesStandard Deviation 211.8
SSB Warning and Non-SSB Promotion PosterTotal Calories Per Transaction332.0 caloriesStandard Deviation 239.8
Other Pre-specified

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)

Time frame: 4 weeks baseline, 4 weeks intervention

ArmMeasureValue (MEAN)Dispersion
Baseline for Calorie/Control PosterHealthy Perceptions of Non-SSBs4.79 units on a scaleStandard Deviation 0.81
Baseline for SSB Warning and Non-SSB Promotion PosterHealthy Perceptions of Non-SSBs4.83 units on a scaleStandard Deviation 0.77
Calorie/Control PosterHealthy Perceptions of Non-SSBs5.01 units on a scaleStandard Deviation 0.87
SSB Warning and Non-SSB Promotion PosterHealthy Perceptions of Non-SSBs4.96 units on a scaleStandard Deviation 0.79
Other Pre-specified

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)

Time frame: During intervention, 4 weeks

Population: Only asked in the treatment period of participants who reported seeing a poster.

ArmMeasureValue (MEAN)Dispersion
Baseline for Calorie/Control PosterPerceived Influence of Poster Among Those Who Saw it2.01 units on a scaleStandard Deviation 1.25
Baseline for SSB Warning and Non-SSB Promotion PosterPerceived Influence of Poster Among Those Who Saw it2.51 units on a scaleStandard Deviation 1.36
Other Pre-specified

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

Time frame: 4-week baseline and 4-week intervention

Population: This analysis was limited to people who bought a beverage. Students who only purchased food were not included.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Baseline for Calorie/Control PosterPercentage of Participants With Transactions With SSBs Out of All Beverage Transactions57 Participants
Baseline for SSB Warning and Non-SSB Promotion PosterPercentage of Participants With Transactions With SSBs Out of All Beverage Transactions36 Participants
Calorie/Control PosterPercentage of Participants With Transactions With SSBs Out of All Beverage Transactions40 Participants
SSB Warning and Non-SSB Promotion PosterPercentage of Participants With Transactions With SSBs Out of All Beverage Transactions63 Participants
Other Pre-specified

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

Time frame: 4-week baseline and 4-week intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Baseline for Calorie/Control PosterPercentage of Participants With Transactions With SSBs Out of All Food and Beverage Transactions57 Participants
Baseline for SSB Warning and Non-SSB Promotion PosterPercentage of Participants With Transactions With SSBs Out of All Food and Beverage Transactions36 Participants
Calorie/Control PosterPercentage of Participants With Transactions With SSBs Out of All Food and Beverage Transactions40 Participants
SSB Warning and Non-SSB Promotion PosterPercentage of Participants With Transactions With SSBs Out of All Food and Beverage Transactions63 Participants
Other Pre-specified

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)

Time frame: During intervention, 4 weeks

Population: Only asked during the intervention period.

ArmMeasureValue (MEAN)Dispersion
Baseline for Calorie/Control PosterPoster Message Trust3.55 units on a scaleStandard Deviation 1.16
Baseline for SSB Warning and Non-SSB Promotion PosterPoster Message Trust3.94 units on a scaleStandard Deviation 0.86
Other Pre-specified

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)

Time frame: 4 weeks baseline, 4 weeks intervention

ArmMeasureValue (MEAN)Dispersion
Baseline for Calorie/Control PosterUnhealthy Perceptions of SSBs3.05 units on a scaleStandard Deviation 1.07
Baseline for SSB Warning and Non-SSB Promotion PosterUnhealthy Perceptions of SSBs3.04 units on a scaleStandard Deviation 0.98
Calorie/Control PosterUnhealthy Perceptions of SSBs3.09 units on a scaleStandard Deviation 1.06
SSB Warning and Non-SSB Promotion PosterUnhealthy Perceptions of SSBs3.02 units on a scaleStandard Deviation 1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026