Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21TW010837 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
| Universidad Rafael Landivar | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of Participants With Transactions With SSBs Out of All Beverage Transactions |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christina A Roberto, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Rafael Landivar | Guatemala City | Guatemala |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline data on race was not collected for participants assigned to the Arms/Groups "Calorie/Control Poster" and "SSB Warning and Non-SSB Promotion Poster" because these data were collected in Guatemala and race would have a different meaning than race in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Baseline for SSB Warning and Non-SSB Promotion Poster |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Volume of SSBs Per Transaction | Total milliliters of SSBs per transaction from sales data | 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. | Posted | Mean | Standard Deviation | mL of Sugar Sweetened Beverages purchase | Through study period (either 4 weeks baseline, or 4 weeks intervention) | sales item | sales item |
|
8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deputy Director of PEACH Lab | University of Pennsylvania | 2158987093 | thepeachlab@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2017 | Jan 14, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2020 | Jan 14, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 6, 2017 | Jan 14, 2021 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D005518 | Food Preferences |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
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.
Not provided
Not provided
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.
Not provided
| Exposure to beverage calorie information | Behavioral | Calories for sugar-sweetened and non-sugar-sweetened beverages |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the treatment school.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 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. |
| OG002 | 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 |
| OG003 | 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 |
|
|
| Primary | Beverage Calories Per Transaction | Total number of calories for all beverages (SSBs and non-SSBs) per transaction from sales data | 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. | Posted | Mean | Standard Deviation | beverage calories sold | Through study period (either 4 weeks baseline or 4 weeks intervention) | sales item | sales item |
|
|
|
| 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) | Posted | Mean | Standard Deviation | calories | Through time frame (either 4 weeks baseline, or 4 weeks intervention) |
|
|
|
| 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 | Posted | Count of Participants | Participants | 4-week baseline and 4-week intervention |
|
|
|
| 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 | This analysis was limited to people who bought a beverage. Students who only purchased food were not included. | Posted | Count of Participants | Participants | 4-week baseline and 4-week intervention |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | 4 weeks baseline, 4 weeks intervention |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | 4 weeks baseline, 4 weeks intervention |
|
|
|
| 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) | Only asked in the treatment period of participants who reported seeing a poster. | Posted | Mean | Standard Deviation | units on a scale | During intervention, 4 weeks |
|
|
|
| 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) | Only asked during the intervention period. | Posted | Mean | Standard Deviation | units on a scale | During intervention, 4 weeks |
|
|
|
| 0 |
| 167 |
| 0 |
| 167 |
| 0 |
| 167 |
| EG001 | 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. | 0 | 145 | 0 | 145 | 0 | 145 |
| EG002 | 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 | 0 | 143 | 0 | 143 | 0 | 143 |
| EG003 | 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 | 0 | 173 | 0 | 173 | 0 | 173 |
Not provided
Not provided
Not provided
| sales item |
|