Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-28 @ 7:39 AM
Study NCT ID:
NCT04165304
Status:
TERMINATED
Last Update Posted:
2020-04-13
First Post:
2019-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact on Drinking Behaviour in Sixth-grade Students Through Changing the School Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 431}}, 'statusModule': {'whyStopped': 'Since schools are closed due to the current corona virus situation, the study cannot be continued.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-09', 'studyFirstSubmitDate': '2019-11-11', 'studyFirstSubmitQcDate': '2019-11-14', 'lastUpdatePostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consumption of mean liquid free sugar intake per week (g) by using the 7-day fluid record', 'timeFrame': '1 week', 'description': 'self report of fluid consumption'}], 'secondaryOutcomes': [{'measure': 'Absolute (mL) and relative (%) contribution of each fluid intake category to total fluid intake by using the 7-day fluid record', 'timeFrame': '1 week', 'description': 'self report of fluid consumption, the measure presents only one outcome "fluid intake", which will be reported in "ml" and "%".'}, {'measure': 'Water intake by using the 7-day fluid record with the proportion of children meeting the EFSA adequate intake for water from fluids', 'timeFrame': '1 week', 'description': 'self report of fluid consumption'}, {'measure': 'Consumption of free sugar from food by 24-h dietary recall', 'timeFrame': '24 hours', 'description': 'self report of food consumption'}, {'measure': 'Body weight and Body-Mass-Index (BMI) by using body weight and height', 'timeFrame': 'Start, 3-4 months, 7-8 months', 'description': 'Measured with a calibrated body scale in light clothes and without shoes'}, {'measure': 'Abdominal girth', 'timeFrame': 'Start, 3-4 months, 7-8 months', 'description': 'inelastic tape'}, {'measure': 'Physical activity', 'timeFrame': 'Start, 3-4 months, 7-8 months', 'description': 'International Physical Activity Questionnaire for Adolescents (IPAQ-A), scale title "Physical activity of adolescents", scale minimum "0", scale maximum "7", higher scores mean a better outcome'}, {'measure': 'Socio-demographic and socioeconomic factors', 'timeFrame': 'after 7-8 months', 'description': 'questionnaire, scale title "socio-demographic and socio-econimoc status", scale minimum is "0", scale maximum is "3", higher scores mean a better outcome'}, {'measure': 'Sales data (frequencies of beverages) of the vending machine and school cafeteria operators', 'timeFrame': 'through study completion, an average of 8 month', 'description': 'Interview'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Students of the 6. Grade']}, 'referencesModule': {'references': [{'pmid': '20646222', 'type': 'BACKGROUND', 'citation': "Popkin BM, D'Anci KE, Rosenberg IH. Water, hydration, and health. Nutr Rev. 2010 Aug;68(8):439-58. doi: 10.1111/j.1753-4887.2010.00304.x."}, {'pmid': '27367719', 'type': 'BACKGROUND', 'citation': 'Duffey KJ, Poti J. Modeling the Effect of Replacing Sugar-Sweetened Beverage Consumption with Water on Energy Intake, HBI Score, and Obesity Prevalence. Nutrients. 2016 Jun 28;8(7):395. doi: 10.3390/nu8070395.'}, {'pmid': '22332062', 'type': 'BACKGROUND', 'citation': 'McGuire S. U.S. Department of Agriculture and U.S. Department of Health and Human Services, Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, January 2011. Adv Nutr. 2011 May;2(3):293-4. doi: 10.3945/an.111.000430. Epub 2011 Apr 30. No abstract available.'}, {'pmid': '23260723', 'type': 'BACKGROUND', 'citation': 'Han E, Powell LM. Consumption patterns of sugar-sweetened beverages in the United States. J Acad Nutr Diet. 2013 Jan;113(1):43-53. doi: 10.1016/j.jand.2012.09.016.'}, {'pmid': '29237159', 'type': 'BACKGROUND', 'citation': 'Luger M, Lafontan M, Bes-Rastrollo M, Winzer E, Yumuk V, Farpour-Lambert N. Sugar-Sweetened Beverages and Weight Gain in Children and Adults: A Systematic Review from 2013 to 2015 and a Comparison with Previous Studies. Obes Facts. 2017;10(6):674-693. doi: 10.1159/000484566. Epub 2017 Dec 14.'}, {'pmid': '23966427', 'type': 'BACKGROUND', 'citation': 'Malik VS, Pan A, Willett WC, Hu FB. Sugar-sweetened beverages and weight gain in children and adults: a systematic review and meta-analysis. Am J Clin Nutr. 2013 Oct;98(4):1084-102. doi: 10.3945/ajcn.113.058362. Epub 2013 Aug 21.'}, {'pmid': '23321486', 'type': 'BACKGROUND', 'citation': 'Te Morenga L, Mallard S, Mann J. Dietary sugars and body weight: systematic review and meta-analyses of randomised controlled trials and cohort studies. BMJ. 2012 Jan 15;346:e7492. doi: 10.1136/bmj.e7492.'}, {'pmid': '26777597', 'type': 'BACKGROUND', 'citation': 'Ma Y, He FJ, Yin Y, Hashem KM, MacGregor GA. Gradual reduction of sugar in soft drinks without substitution as a strategy to reduce overweight, obesity, and type 2 diabetes: a modelling study. Lancet Diabetes Endocrinol. 2016 Feb;4(2):105-14. doi: 10.1016/S2213-8587(15)00477-5. Epub 2016 Jan 7.'}, {'pmid': '24932880', 'type': 'BACKGROUND', 'citation': 'Greenwood DC, Threapleton DE, Evans CE, Cleghorn CL, Nykjaer C, Woodhead C, Burley VJ. Association between sugar-sweetened and artificially sweetened soft drinks and type 2 diabetes: systematic review and dose-response meta-analysis of prospective studies. Br J Nutr. 2014 Sep 14;112(5):725-34. doi: 10.1017/S0007114514001329. Epub 2014 Jun 16.'}, {'pmid': '12949310', 'type': 'BACKGROUND', 'citation': 'Marshall TA, Levy SM, Broffitt B, Warren JJ, Eichenberger-Gilmore JM, Burns TL, Stumbo PJ. Dental caries and beverage consumption in young children. Pediatrics. 2003 Sep;112(3 Pt 1):e184-91. doi: 10.1542/peds.112.3.e184.'}, {'pmid': '26339945', 'type': 'BACKGROUND', 'citation': 'Wilder JR, Kaste LM, Handler A, Chapple-McGruder T, Rankin KM. The association between sugar-sweetened beverages and dental caries among third-grade students in Georgia. J Public Health Dent. 2016 Winter;76(1):76-84. doi: 10.1111/jphd.12116. Epub 2015 Sep 4.'}, {'pmid': '23488503', 'type': 'BACKGROUND', 'citation': 'Basu S, McKee M, Galea G, Stuckler D. Relationship of soft drink consumption to global overweight, obesity, and diabetes: a cross-national analysis of 75 countries. Am J Public Health. 2013 Nov;103(11):2071-7. doi: 10.2105/AJPH.2012.300974. Epub 2013 Mar 14.'}, {'pmid': '26244332', 'type': 'BACKGROUND', 'citation': 'Singh GM, Micha R, Khatibzadeh S, Shi P, Lim S, Andrews KG, Engell RE, Ezzati M, Mozaffarian D; Global Burden of Diseases Nutrition and Chronic Diseases Expert Group (NutriCoDE). Global, Regional, and National Consumption of Sugar-Sweetened Beverages, Fruit Juices, and Milk: A Systematic Assessment of Beverage Intake in 187 Countries. PLoS One. 2015 Aug 5;10(8):e0124845. doi: 10.1371/journal.pone.0124845. eCollection 2015.'}, {'pmid': '26124185', 'type': 'BACKGROUND', 'citation': 'Singh GM, Micha R, Khatibzadeh S, Lim S, Ezzati M, Mozaffarian D; Global Burden of Diseases Nutrition and Chronic Diseases Expert Group (NutriCoDE). Estimated Global, Regional, and National Disease Burdens Related to Sugar-Sweetened Beverage Consumption in 2010. Circulation. 2015 Aug 25;132(8):639-66. doi: 10.1161/CIRCULATIONAHA.114.010636. Epub 2015 Jun 29.'}, {'pmid': '25776039', 'type': 'BACKGROUND', 'citation': 'Reichelt AC, Killcross S, Hambly LD, Morris MJ, Westbrook RF. Impact of adolescent sucrose access on cognitive control, recognition memory, and parvalbumin immunoreactivity. Learn Mem. 2015 Mar 16;22(4):215-24. doi: 10.1101/lm.038000.114. Print 2015 Apr.'}, {'pmid': '27384573', 'type': 'BACKGROUND', 'citation': 'Yu CJ, Du JC, Chiou HC, Feng CC, Chung MY, Yang W, Chen YS, Chien LC, Hwang B, Chen ML. Sugar-Sweetened Beverage Consumption Is Adversely Associated with Childhood Attention Deficit/Hyperactivity Disorder. Int J Environ Res Public Health. 2016 Jul 4;13(7):678. doi: 10.3390/ijerph13070678.'}, {'pmid': '24452237', 'type': 'BACKGROUND', 'citation': 'Mennella JA. Ontogeny of taste preferences: basic biology and implications for health. Am J Clin Nutr. 2014 Mar;99(3):704S-11S. doi: 10.3945/ajcn.113.067694. Epub 2014 Jan 22.'}, {'pmid': '27040694', 'type': 'BACKGROUND', 'citation': 'Muckelbauer R, Gortmaker SL, Libuda L, Kersting M, Clausen K, Adelberger B, Muller-Nordhorn J. Changes in water and sugar-containing beverage consumption and body weight outcomes in children. Br J Nutr. 2016 Jun;115(11):2057-66. doi: 10.1017/S0007114516001136. Epub 2016 Apr 4.'}, {'pmid': '16164589', 'type': 'BACKGROUND', 'citation': 'Puffer S, Torgerson DJ, Watson J. Cluster randomized controlled trials. J Eval Clin Pract. 2005 Oct;11(5):479-83. doi: 10.1111/j.1365-2753.2005.00568.x.'}, {'pmid': '25805783', 'type': 'BACKGROUND', 'citation': 'Ahluwalia N, Dalmasso P, Rasmussen M, Lipsky L, Currie C, Haug E, Kelly C, Damsgaard MT, Due P, Tabak I, Ercan O, Maes L, Aasvee K, Cavallo F. Trends in overweight prevalence among 11-, 13- and 15-year-olds in 25 countries in Europe, Canada and USA from 2002 to 2010. Eur J Public Health. 2015 Apr;25 Suppl 2:28-32. doi: 10.1093/eurpub/ckv016.'}, {'pmid': '20060008', 'type': 'BACKGROUND', 'citation': 'Swithers SE, Martin AA, Davidson TL. High-intensity sweeteners and energy balance. Physiol Behav. 2010 Apr 26;100(1):55-62. doi: 10.1016/j.physbeh.2009.12.021. Epub 2010 Jan 6.'}, {'pmid': '28878034', 'type': 'BACKGROUND', 'citation': 'Johnson EC, Peronnet F, Jansen LT, Capitan-Jimenez C, Adams JD, Guelinckx I, Jimenez L, Mauromoustakos A, Kavouras SA. Validation Testing Demonstrates Efficacy of a 7-Day Fluid Record to Estimate Daily Water Intake in Adult Men and Women When Compared with Total Body Water Turnover Measurement. J Nutr. 2017 Oct;147(10):2001-2007. doi: 10.3945/jn.117.253377. Epub 2017 Sep 6.'}, {'pmid': '19011653', 'type': 'BACKGROUND', 'citation': 'Hagstromer M, Bergman P, De Bourdeaudhuij I, Ortega FB, Ruiz JR, Manios Y, Rey-Lopez JP, Phillipp K, von Berlepsch J, Sjostrom M; HELENA Study Group. Concurrent validity of a modified version of the International Physical Activity Questionnaire (IPAQ-A) in European adolescents: The HELENA Study. Int J Obes (Lond). 2008 Nov;32 Suppl 5:S42-8. doi: 10.1038/ijo.2008.182.'}, {'pmid': '25053894', 'type': 'BACKGROUND', 'citation': 'Zhang S, Paul J, Nantha-Aree M, Buckley N, Shahzad U, Cheng J, DeBeer J, Winemaker M, Wismer D, Punthakee D, Avram V, Thabane L. Empirical comparison of four baseline covariate adjustment methods in analysis of continuous outcomes in randomized controlled trials. Clin Epidemiol. 2014 Jul 14;6:227-35. doi: 10.2147/CLEP.S56554. eCollection 2014.'}, {'pmid': '3032685', 'type': 'BACKGROUND', 'citation': 'Manachini PL, Parini C, Fortina MG, Benazzi L. BliI, a restriction endonuclease from Bacillus licheniformis. FEBS Lett. 1987 Apr 20;214(2):305-7. doi: 10.1016/0014-5793(87)80075-3.'}, {'pmid': '26857624', 'type': 'BACKGROUND', 'citation': 'Grassi E, Evans A, Ranjit N, Pria SD, Messina L. Using a mixed-methods approach to measure impact of a school-based nutrition and media education intervention study on fruit and vegetable intake of Italian children. Public Health Nutr. 2016 Aug;19(11):1952-63. doi: 10.1017/S1368980015003729. Epub 2016 Feb 9.'}], 'seeAlsoLinks': [{'url': 'https://apps.who.int/iris/bitstream/handle/10665/42665/WHO_TRS_916.pdf;jsessionid=D5FE5BA9BEA21640073612235DFE400D?sequence=1', 'label': 'World Health Organization (WHO). Diet, nutrition and the prevention of chronic diseases: report of a Joint WHO/FAO Expert Consultation'}, {'url': 'https://www.who.int/nutrition/publications/guidelines/sugars_intake/en/', 'label': 'Sugars intake for adults and children'}, {'url': 'https://www.efsa.europa.eu/de/efsajournal/pub/1459', 'label': 'Scientific Opinion on Dietary Reference Values for water'}, {'url': 'https://link.springer.com/article/10.1007/s11205-005-1607-6', 'label': 'The Family Affluence Scale as a Measure of National Wealth: Validation of an Adolescent Self-Report Measure'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of changes in the range of drinks offered in vending machines in schools on the sugar intake of pupils via drinks.', 'detailedDescription': 'Children and adolescents consume a considerable amount of liquid in the form of sugary drinks. A high sugar diet associated not only with the increase in overweight children, but also with type II diabetes, cardiovascular disease and cancer.\n\nIn many schools, cold drink vending machines with different fillings are available offering various sugary drinks.\n\nParticipating schools will be randomised in a ratio of 1:1:1 into three groups. In one intervention group, the vending machines will be re-equipped to contain 60% drinks containing a maximum of 6.7g sugar/100ml, 20% drinks containing more than 6.7g sugar/100ml and 20% water. In the second intervention group, the vending machines offer 80% water, 20% products with a maximum of 6.7g sugar/100ml. In the control group, the range of products offered by the vending machines remains unchanged. Information of the students drinking habits, total fluid intake and sugar intake in the form of food and drinks will be collected. In addition, data such as body height, body weight, physical activity and socio-democratic or socio-economic data will be accumulated. The sales figures of the drinks in the vending machines will be recorded and information about the surroundings of the schools (fast food chains, supermarkets, etc.) will be collected.\n\nThe survey of students and data collection will be repeated three times. In a sub-study, demographic data and the frequency of consumption of sugared beverages and water are collected from 2 focus groups. In addition, participants will complete a questionnaire on general attitudes towards sugary drinks or water, obstacles to and incentives for reducing sugar consumption by liquids or increasing water consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students in one of the recruited schools\n* Appropriate knowledge of the German language\n\nExclusion Criteria:\n\n* No signed consent of parent and of child'}, 'identificationModule': {'nctId': 'NCT04165304', 'briefTitle': 'Impact on Drinking Behaviour in Sixth-grade Students Through Changing the School Environment', 'organization': {'class': 'OTHER', 'fullName': 'Special Institute for Preventive Cardiology And Nutrition'}, 'officialTitle': 'Impact on Drinking Behaviour in Sixth-grade Students Through Changing the School Environment', 'orgStudyIdInfo': {'id': 'Version 1.4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'the range of products offered by the vending machines remains unchanged'}, {'type': 'OTHER', 'label': 'Intervention group 1', 'description': 'vending machines will be re-equipped to contain 60% drinks containing a maximum of 6.7g sugar/100ml, 20% drinks containing more than 6.7g sugar/100ml and 20% water', 'interventionNames': ['Dietary Supplement: sugar reduction']}, {'type': 'OTHER', 'label': 'Intervention group 2', 'description': 'In the second intervention group, the vending machines offer 80% water and 20% products with a maximum of 6.7g sugar/100ml.', 'interventionNames': ['Dietary Supplement: sugar reduction']}], 'interventions': [{'name': 'sugar reduction', 'type': 'DIETARY_SUPPLEMENT', 'description': 'sugar reduction in the offered drinks', 'armGroupLabels': ['Intervention group 1', 'Intervention group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Sankt Veit an der Glan', 'state': 'Carinthia', 'country': 'Austria', 'facility': 'NMS St. Veit/Glan', 'geoPoint': {'lat': 46.76806, 'lon': 14.36028}}, {'zip': '9800', 'city': 'Spittal an der Drau', 'state': 'Carinthia', 'country': 'Austria', 'facility': 'NMS II Spittal/Drau', 'geoPoint': {'lat': 46.8, 'lon': 13.5}}, {'zip': '2243', 'city': 'Matzen', 'state': 'Gänserndorf', 'country': 'Austria', 'facility': 'Sport-Mittelschule Matzen-Raggendorf', 'geoPoint': {'lat': 48.4, 'lon': 16.7}}, {'zip': '2540', 'city': 'Bad Vöslau', 'state': 'Lower Austria', 'country': 'Austria', 'facility': 'Gymnasium Bad Vöslau/Gainfard', 'geoPoint': {'lat': 47.96533, 'lon': 16.21359}}, {'zip': '2821', 'city': 'Lanzenkirchen', 'state': 'Lower Austria', 'country': 'Austria', 'facility': 'NMS Lanzenkirchen', 'geoPoint': {'lat': 47.73621, 'lon': 16.21985}}, {'zip': '2700', 'city': 'Wiener Neustadt', 'state': 'Lower Austria', 'country': 'Austria', 'facility': 'BG/BRG Zehnergasse', 'geoPoint': {'lat': 47.80485, 'lon': 16.23196}}, {'zip': '1230', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Bischöfliches Gymnasium Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8940', 'city': 'Liezen', 'state': 'Styria', 'country': 'Austria', 'facility': 'NMS Liezen', 'geoPoint': {'lat': 47.56667, 'lon': 14.23333}}, {'zip': '4600', 'city': 'Wels', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'BG/BRG Wels', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'zip': '1020', 'city': 'Vienna', 'country': 'Austria', 'facility': 'GRG II Zirkusgasse', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1060', 'city': 'Vienna', 'country': 'Austria', 'facility': 'BRG Marchettigasse', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1110', 'city': 'Vienna', 'country': 'Austria', 'facility': 'GRG Gottschalkgasse', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1180', 'city': 'Vienna', 'country': 'Austria', 'facility': 'GWIKU 18 Haizingergasse', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1220', 'city': 'Vienna', 'country': 'Austria', 'facility': 'LWS Donaustadt', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1230', 'city': 'Vienna', 'country': 'Austria', 'facility': 'GRG 23', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Special Institute for Preventive Cardiology And Nutrition', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danone Global Research & Innovation Center', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}