Trial Outcomes & Findings for Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction (NCT NCT04022694)
NCT ID: NCT04022694
Last Updated: 2021-03-25
Results Overview
Total milliliters of SSBs per transaction from sales data
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
628 participants
Primary outcome timeframe
Through study period (either 4 weeks baseline, or 4 weeks intervention)
Results posted on
2021-03-25
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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 intervention school.
|
Calorie/Control Poster
This poster will display images of both Sugar Sweetened Beverages (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.
Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages
|
SSB Warning and Non-SSB Promotion Poster
This poster will display images of both Sugar Sweetened Beverages (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.
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
167
|
145
|
143
|
173
|
|
Overall Study
COMPLETED
|
167
|
145
|
143
|
173
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Baseline for Calorie/Control Poster
n=167 Participants
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
n=145 Participants
We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the treatment school.
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
167 Participants
n=167 Participants
|
145 Participants
n=145 Participants
|
312 Participants
n=312 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=167 Participants
|
0 Participants
n=145 Participants
|
0 Participants
n=312 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=167 Participants
|
0 Participants
n=145 Participants
|
0 Participants
n=312 Participants
|
|
Age, Continuous
|
15.3 years
STANDARD_DEVIATION 1.6 • n=167 Participants
|
14.9 years
STANDARD_DEVIATION 1.4 • n=145 Participants
|
15.1 years
STANDARD_DEVIATION 1.5 • n=312 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=167 Participants
|
68 Participants
n=145 Participants
|
126 Participants
n=312 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=167 Participants
|
77 Participants
n=145 Participants
|
186 Participants
n=312 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Guatemala
|
167 participants
n=167 Participants
|
145 participants
n=145 Participants
|
312 participants
n=312 Participants
|
PRIMARY outcome
Timeframe: 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.
Total milliliters of SSBs per transaction from sales data
Outcome measures
| Measure |
Baseline for Calorie/Control Poster
n=3642 sales item
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
n=3477 sales item
We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.
|
Calorie/Control Poster
n=3898 sales item
This poster will display images of both Sugar Sweetened Beverages (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.
Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages
|
SSB Warning and Non-SSB Promotion Poster
n=3533 sales item
This poster will display images of both Sugar Sweetened Beverages (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.
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
|
|---|---|---|---|---|
|
Volume of SSBs Per Transaction
|
116.2 mL of Sugar Sweetened Beverages purchase
Standard Deviation 212.5
|
89.8 mL of Sugar Sweetened Beverages purchase
Standard Deviation 160.1
|
115.3 mL of Sugar Sweetened Beverages purchase
Standard Deviation 211.8
|
103.4 mL of Sugar Sweetened Beverages purchase
Standard Deviation 176.2
|
PRIMARY outcome
Timeframe: 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.
Total number of calories for all beverages (SSBs and non-SSBs) per transaction from sales data
Outcome measures
| Measure |
Baseline for Calorie/Control Poster
n=3642 sales item
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
n=3477 sales item
We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.
|
Calorie/Control Poster
n=3898 sales item
This poster will display images of both Sugar Sweetened Beverages (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.
Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages
|
SSB Warning and Non-SSB Promotion Poster
n=3533 sales item
This poster will display images of both Sugar Sweetened Beverages (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.
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
|
|---|---|---|---|---|
|
Beverage Calories Per Transaction
|
45.1 beverage calories sold
Standard Deviation 83.7
|
35.9 beverage calories sold
Standard Deviation 67.1
|
41.2 beverage calories sold
Standard Deviation 75.9
|
39.0 beverage calories sold
Standard Deviation 69.0
|
SECONDARY outcome
Timeframe: Through 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)
Outcome measures
| Measure |
Baseline for Calorie/Control Poster
n=167 Participants
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
n=145 Participants
We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.
|
Calorie/Control Poster
n=143 Participants
This poster will display images of both Sugar Sweetened Beverages (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.
Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages
|
SSB Warning and Non-SSB Promotion Poster
n=173 Participants
This poster will display images of both Sugar Sweetened Beverages (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.
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
|
|---|---|---|---|---|
|
Total Calories Per Transaction
|
290.8 calories
Standard Deviation 224.2
|
338.5 calories
Standard Deviation 222.6
|
287.5 calories
Standard Deviation 211.8
|
332.0 calories
Standard Deviation 239.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4-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
Outcome measures
| Measure |
Baseline for Calorie/Control Poster
n=167 Participants
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
n=145 Participants
We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.
|
Calorie/Control Poster
n=143 Participants
This poster will display images of both Sugar Sweetened Beverages (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.
Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages
|
SSB Warning and Non-SSB Promotion Poster
n=173 Participants
This poster will display images of both Sugar Sweetened Beverages (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.
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
|
|---|---|---|---|---|
|
Percentage of Participants With Transactions With SSBs Out of All Food and Beverage Transactions
|
57 Participants
|
36 Participants
|
40 Participants
|
63 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4-week baseline and 4-week interventionPopulation: This analysis was limited to people who bought a beverage. Students who only purchased food were not included.
Percentage of participants with transactions that have sugar sweetened beverages out of all participants who had beverage transactions
Outcome measures
| Measure |
Baseline for Calorie/Control Poster
n=76 Participants
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
n=65 Participants
We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.
|
Calorie/Control Poster
n=48 Participants
This poster will display images of both Sugar Sweetened Beverages (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.
Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages
|
SSB Warning and Non-SSB Promotion Poster
n=105 Participants
This poster will display images of both Sugar Sweetened Beverages (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.
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
|
|---|---|---|---|---|
|
Percentage of Participants With Transactions With SSBs Out of All Beverage Transactions
|
57 Participants
|
36 Participants
|
40 Participants
|
63 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 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)
Outcome measures
| Measure |
Baseline for Calorie/Control Poster
n=167 Participants
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
n=145 Participants
We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.
|
Calorie/Control Poster
n=143 Participants
This poster will display images of both Sugar Sweetened Beverages (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.
Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages
|
SSB Warning and Non-SSB Promotion Poster
n=173 Participants
This poster will display images of both Sugar Sweetened Beverages (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.
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
|
|---|---|---|---|---|
|
Unhealthy Perceptions of SSBs
|
3.05 units on a scale
Standard Deviation 1.07
|
3.04 units on a scale
Standard Deviation 0.98
|
3.09 units on a scale
Standard Deviation 1.06
|
3.02 units on a scale
Standard Deviation 1.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 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)
Outcome measures
| Measure |
Baseline for Calorie/Control Poster
n=167 Participants
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
n=145 Participants
We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.
|
Calorie/Control Poster
n=143 Participants
This poster will display images of both Sugar Sweetened Beverages (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.
Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages
|
SSB Warning and Non-SSB Promotion Poster
n=173 Participants
This poster will display images of both Sugar Sweetened Beverages (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.
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
|
|---|---|---|---|---|
|
Healthy Perceptions of Non-SSBs
|
4.79 units on a scale
Standard Deviation 0.81
|
4.83 units on a scale
Standard Deviation 0.77
|
5.01 units on a scale
Standard Deviation 0.87
|
4.96 units on a scale
Standard Deviation 0.79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During intervention, 4 weeksPopulation: Only asked in the treatment period of participants who reported seeing a poster.
"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)
Outcome measures
| Measure |
Baseline for Calorie/Control Poster
n=87 Participants
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
n=110 Participants
We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.
|
Calorie/Control Poster
This poster will display images of both Sugar Sweetened Beverages (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.
Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages
|
SSB Warning and Non-SSB Promotion Poster
This poster will display images of both Sugar Sweetened Beverages (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.
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
|
|---|---|---|---|---|
|
Perceived Influence of Poster Among Those Who Saw it
|
2.01 units on a scale
Standard Deviation 1.25
|
2.51 units on a scale
Standard Deviation 1.36
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During intervention, 4 weeksPopulation: Only asked during the intervention period.
"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)
Outcome measures
| Measure |
Baseline for Calorie/Control Poster
n=143 Participants
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
n=173 Participants
We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.
|
Calorie/Control Poster
This poster will display images of both Sugar Sweetened Beverages (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.
Exposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages
|
SSB Warning and Non-SSB Promotion Poster
This poster will display images of both Sugar Sweetened Beverages (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.
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
|
|---|---|---|---|---|
|
Poster Message Trust
|
3.55 units on a scale
Standard Deviation 1.16
|
3.94 units on a scale
Standard Deviation 0.86
|
—
|
—
|
Adverse Events
Baseline for Calorie/Control Poster
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Baseline for SSB Warning and Non-SSB Promotion Poster
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Calorie/Control Poster
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SSB Warning and Non-SSB Promotion Poster
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place