Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT04022694
Status:
COMPLETED
Last Update Posted:
2021-03-25
First Post:
2019-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005518', 'term': 'Food Preferences'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thepeachlab@gmail.com', 'phone': '2158987093', 'title': 'Deputy Director of PEACH Lab', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Baseline for Calorie/Control Poster', 'description': 'We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.', 'otherNumAtRisk': 167, 'deathsNumAtRisk': 167, 'otherNumAffected': 0, 'seriousNumAtRisk': 167, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Baseline for SSB Warning and Non-SSB Promotion Poster', 'description': 'We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 0, 'seriousNumAtRisk': 145, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Calorie/Control Poster', 'description': '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.\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 0, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'SSB Warning and Non-SSB Promotion Poster', 'description': '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.\n\nExposure 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\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 173, 'otherNumAffected': 0, 'seriousNumAtRisk': 173, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Volume of SSBs Per Transaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}, {'value': 'NA', 'groupId': 'OG003'}]}, {'units': 'sales item', 'counts': [{'value': '3642', 'groupId': 'OG000'}, {'value': '3477', 'groupId': 'OG001'}, {'value': '3898', 'groupId': 'OG002'}, {'value': '3533', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline for Calorie/Control Poster', 'description': 'We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.'}, {'id': 'OG001', 'title': 'Baseline for SSB Warning and Non-SSB Promotion Poster', 'description': 'We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.'}, {'id': 'OG002', 'title': 'Calorie/Control Poster', 'description': '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.\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}, {'id': 'OG003', 'title': 'SSB Warning and Non-SSB Promotion Poster', 'description': '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.\n\nExposure 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\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}], 'classes': [{'categories': [{'measurements': [{'value': '116.2', 'spread': '212.5', 'groupId': 'OG000'}, {'value': '89.8', 'spread': '160.1', 'groupId': 'OG001'}, {'value': '115.3', 'spread': '211.8', 'groupId': 'OG002'}, {'value': '103.4', 'spread': '176.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study period (either 4 weeks baseline, or 4 weeks intervention)', 'description': 'Total milliliters of SSBs per transaction from sales data', 'unitOfMeasure': 'mL of Sugar Sweetened Beverages purchase', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sales item', 'denomUnitsSelected': 'sales item', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Beverage Calories Per Transaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}, {'value': 'NA', 'groupId': 'OG003'}]}, {'units': 'sales item', 'counts': [{'value': '3642', 'groupId': 'OG000'}, {'value': '3477', 'groupId': 'OG001'}, {'value': '3898', 'groupId': 'OG002'}, {'value': '3533', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline for Calorie/Control Poster', 'description': 'We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.'}, {'id': 'OG001', 'title': 'Baseline for SSB Warning and Non-SSB Promotion Poster', 'description': 'We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.'}, {'id': 'OG002', 'title': 'Calorie/Control Poster', 'description': '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.\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}, {'id': 'OG003', 'title': 'SSB Warning and Non-SSB Promotion Poster', 'description': '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.\n\nExposure 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\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}], 'classes': [{'categories': [{'measurements': [{'value': '45.1', 'spread': '83.7', 'groupId': 'OG000'}, {'value': '35.9', 'spread': '67.1', 'groupId': 'OG001'}, {'value': '41.2', 'spread': '75.9', 'groupId': 'OG002'}, {'value': '39.0', 'spread': '69.0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study period (either 4 weeks baseline or 4 weeks intervention)', 'description': 'Total number of calories for all beverages (SSBs and non-SSBs) per transaction from sales data', 'unitOfMeasure': 'beverage calories sold', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'sales item', 'denomUnitsSelected': 'sales item', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Total Calories Per Transaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '173', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline for Calorie/Control Poster', 'description': 'We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.'}, {'id': 'OG001', 'title': 'Baseline for SSB Warning and Non-SSB Promotion Poster', 'description': 'We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.'}, {'id': 'OG002', 'title': 'Calorie/Control Poster', 'description': '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.\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}, {'id': 'OG003', 'title': 'SSB Warning and Non-SSB Promotion Poster', 'description': '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.\n\nExposure 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\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}], 'classes': [{'categories': [{'measurements': [{'value': '290.8', 'spread': '224.2', 'groupId': 'OG000'}, {'value': '338.5', 'spread': '222.6', 'groupId': 'OG001'}, {'value': '287.5', 'spread': '211.8', 'groupId': 'OG002'}, {'value': '332.0', 'spread': '239.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through time frame (either 4 weeks baseline, or 4 weeks intervention)', 'description': '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)', 'unitOfMeasure': 'calories', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Transactions With SSBs Out of All Food and Beverage Transactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '173', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline for Calorie/Control Poster', 'description': 'We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.'}, {'id': 'OG001', 'title': 'Baseline for SSB Warning and Non-SSB Promotion Poster', 'description': 'We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.'}, {'id': 'OG002', 'title': 'Calorie/Control Poster', 'description': '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.\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}, {'id': 'OG003', 'title': 'SSB Warning and Non-SSB Promotion Poster', 'description': '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.\n\nExposure 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\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-week baseline and 4-week intervention', 'description': 'Percentage of participants with transactions that have sugar sweetened beverages out of all participants who had food and beverage transactions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Transactions With SSBs Out of All Beverage Transactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline for Calorie/Control Poster', 'description': 'We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.'}, {'id': 'OG001', 'title': 'Baseline for SSB Warning and Non-SSB Promotion Poster', 'description': 'We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.'}, {'id': 'OG002', 'title': 'Calorie/Control Poster', 'description': '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.\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}, {'id': 'OG003', 'title': 'SSB Warning and Non-SSB Promotion Poster', 'description': '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.\n\nExposure 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\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-week baseline and 4-week intervention', 'description': 'Percentage of participants with transactions that have sugar sweetened beverages out of all participants who had beverage transactions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was limited to people who bought a beverage. Students who only purchased food were not included.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Unhealthy Perceptions of SSBs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '173', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline for Calorie/Control Poster', 'description': 'We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.'}, {'id': 'OG001', 'title': 'Baseline for SSB Warning and Non-SSB Promotion Poster', 'description': 'We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.'}, {'id': 'OG002', 'title': 'Calorie/Control Poster', 'description': '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.\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}, {'id': 'OG003', 'title': 'SSB Warning and Non-SSB Promotion Poster', 'description': '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.\n\nExposure 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\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}], 'classes': [{'categories': [{'measurements': [{'value': '3.05', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '3.04', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '3.09', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '3.02', 'spread': '1.00', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks baseline, 4 weeks intervention', 'description': 'Average of perceptions of healthiness (measured on Likert scales) for two items (1=Extremely unhealthy; 7=Extremely healthy, lower values are more accurate)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Healthy Perceptions of Non-SSBs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}, {'value': '173', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline for Calorie/Control Poster', 'description': 'We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.'}, {'id': 'OG001', 'title': 'Baseline for SSB Warning and Non-SSB Promotion Poster', 'description': 'We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.'}, {'id': 'OG002', 'title': 'Calorie/Control Poster', 'description': '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.\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}, {'id': 'OG003', 'title': 'SSB Warning and Non-SSB Promotion Poster', 'description': '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.\n\nExposure 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\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}], 'classes': [{'categories': [{'measurements': [{'value': '4.79', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '4.83', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '5.01', 'spread': '0.87', 'groupId': 'OG002'}, {'value': '4.96', 'spread': '0.79', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks baseline, 4 weeks intervention', 'description': 'Average of perceptions of healthiness (measured on Likert scales) for two items (1=Extremely unhealthy; 7=Extremely healthy, higher values are more accurate)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Perceived Influence of Poster Among Those Who Saw it', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calorie/Control Poster', 'description': '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.\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}, {'id': 'OG001', 'title': 'SSB Warning and Non-SSB Promotion Poster', 'description': '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.\n\nExposure 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\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}], 'classes': [{'categories': [{'measurements': [{'value': '2.01', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '2.51', 'spread': '1.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During intervention, 4 weeks', 'description': '"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)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only asked in the treatment period of participants who reported seeing a poster.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Poster Message Trust', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Calorie/Control Poster', 'description': '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.\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}, {'id': 'OG001', 'title': 'SSB Warning and Non-SSB Promotion Poster', 'description': '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.\n\nExposure 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\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}], 'classes': [{'categories': [{'measurements': [{'value': '3.55', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '3.94', 'spread': '0.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During intervention, 4 weeks', 'description': '"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)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only asked during the intervention period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Baseline for Calorie/Control Poster', 'description': 'We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.'}, {'id': 'FG001', 'title': 'Baseline for SSB Warning and Non-SSB Promotion Poster', 'description': 'We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.'}, {'id': 'FG002', 'title': 'Calorie/Control Poster', 'description': '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.\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}, {'id': 'FG003', 'title': 'SSB Warning and Non-SSB Promotion Poster', 'description': '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.\n\nExposure 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\n\nExposure to beverage calorie information: Calories for sugar-sweetened and non-sugar-sweetened beverages'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'comment': 'This was a cross-sectional study, so participants at baseline -- were not the same as exposure.', 'groupId': 'FG002', 'numSubjects': '143'}, {'comment': 'This was a cross-sectional study, so participants at baseline -- were not the same as exposure.', 'groupId': 'FG003', 'numSubjects': '173'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '143'}, {'groupId': 'FG003', 'numSubjects': '173'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Baseline for Calorie/Control Poster', 'description': 'We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.'}, {'id': 'BG001', 'title': 'Baseline for SSB Warning and Non-SSB Promotion Poster', 'description': 'We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the treatment school.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15.3', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '14.9', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '15.1', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '186', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Guatemala', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '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.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-06', 'size': 717595, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-14T10:02', 'hasProtocol': True}, {'date': '2020-04-30', 'size': 159301, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-14T10:04', 'hasProtocol': False}, {'date': '2017-11-06', 'size': 161527, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-01-14T10:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 628}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2019-07-09', 'resultsFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2019-07-16', 'lastUpdatePostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-01', 'studyFirstPostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Transactions With SSBs Out of All Food and Beverage Transactions', 'timeFrame': '4-week baseline and 4-week intervention', 'description': 'Percentage of participants with transactions that have sugar sweetened beverages out of all participants who had food and beverage transactions'}, {'measure': 'Percentage of Participants With Transactions With SSBs Out of All Beverage Transactions', 'timeFrame': '4-week baseline and 4-week intervention', 'description': 'Percentage of participants with transactions that have sugar sweetened beverages out of all participants who had beverage transactions'}, {'measure': 'Unhealthy Perceptions of SSBs', 'timeFrame': '4 weeks baseline, 4 weeks intervention', 'description': 'Average of perceptions of healthiness (measured on Likert scales) for two items (1=Extremely unhealthy; 7=Extremely healthy, lower values are more accurate)'}, {'measure': 'Healthy Perceptions of Non-SSBs', 'timeFrame': '4 weeks baseline, 4 weeks intervention', 'description': 'Average of perceptions of healthiness (measured on Likert scales) for two items (1=Extremely unhealthy; 7=Extremely healthy, higher values are more accurate)'}, {'measure': 'Perceived Influence of Poster Among Those Who Saw it', 'timeFrame': 'During intervention, 4 weeks', 'description': '"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)'}, {'measure': 'Poster Message Trust', 'timeFrame': 'During intervention, 4 weeks', 'description': '"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)'}], 'primaryOutcomes': [{'measure': 'Volume of SSBs Per Transaction', 'timeFrame': 'Through study period (either 4 weeks baseline, or 4 weeks intervention)', 'description': 'Total milliliters of SSBs per transaction from sales data'}, {'measure': 'Beverage Calories Per Transaction', 'timeFrame': 'Through study period (either 4 weeks baseline or 4 weeks intervention)', 'description': 'Total number of calories for all beverages (SSBs and non-SSBs) per transaction from sales data'}], 'secondaryOutcomes': [{'measure': 'Total Calories Per Transaction', 'timeFrame': 'Through time frame (either 4 weeks baseline, or 4 weeks intervention)', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food Labeling', 'Adolescents'], 'conditions': ['Food Preferences']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 12 and 18 years old\n* Made a food or beverage purchase\n* Has permission from parent or caregiver to participate\n* Has not yet completed the purchase assessment\n\nExclusion Criteria:\n\n* Under 12 or over 18 years old\n* Did not make a food or beverage purchase\n* Parent or caregiver refused to give child permission to participate\n* Already participated in the purchase assessment'}, 'identificationModule': {'nctId': 'NCT04022694', 'briefTitle': 'Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Preventing Non-communicable Diseases in Guatemala Through Sugary Drink Reduction', 'orgStudyIdInfo': {'id': 'R21TW010837', 'link': 'https://reporter.nih.gov/quickSearch/R21TW010837', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R21TW010837', 'link': 'https://reporter.nih.gov/quickSearch/R21TW010837', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Calorie/Control Poster', 'description': '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.', 'interventionNames': ['Behavioral: Exposure to beverage calorie information']}, {'type': 'EXPERIMENTAL', 'label': 'SSB Warning and Non-SSB Promotion Poster', 'description': '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.', 'interventionNames': ['Behavioral: Exposure to beverage health information', 'Behavioral: Exposure to beverage calorie information']}, {'type': 'NO_INTERVENTION', 'label': 'Baseline for Calorie/Control Poster', 'description': 'We will collect baseline data from a group of students before posting the Calorie/Control Poster in the control school.'}, {'type': 'NO_INTERVENTION', 'label': 'Baseline for SSB Warning and Non-SSB Promotion Poster', 'description': 'We will collect baseline data from a group of students before posting the SSB Warning and Non-SSB Promotion Poster in the intervention school.'}], 'interventions': [{'name': 'Exposure to beverage health information', 'type': 'BEHAVIORAL', 'description': 'Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information', 'armGroupLabels': ['SSB Warning and Non-SSB Promotion Poster']}, {'name': 'Exposure to beverage calorie information', 'type': 'BEHAVIORAL', 'description': 'Calories for sugar-sweetened and non-sugar-sweetened beverages', 'armGroupLabels': ['Calorie/Control Poster', 'SSB Warning and Non-SSB Promotion Poster']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Universidad Rafael Landivar', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}], 'overallOfficials': [{'name': 'Christina A Roberto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}, {'name': 'Universidad Rafael Landivar', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}