Impact on Drinking Behaviour in Sixth-grade Students Through Changing the School Environment
9 kwietnia 2020 zaktualizowane przez: Special Institute for Preventive Cardiology And Nutrition
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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
In many schools, cold drink vending machines with different fillings are available offering various sugary drinks.
Participating 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.
The 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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
431
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Vienna, Austria, 1020
- GRG II Zirkusgasse
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Vienna, Austria, 1060
- BRG Marchettigasse
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Vienna, Austria, 1110
- GRG Gottschalkgasse
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Vienna, Austria, 1180
- GWIKU 18 Haizingergasse
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Vienna, Austria, 1220
- LWS Donaustadt
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Vienna, Austria, 1230
- GRG 23
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Carinthia
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Spittal An Der Drau, Carinthia, Austria, 9800
- NMS II Spittal/Drau
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St. Veit an der Glan, Carinthia, Austria, 9300
- NMS St. Veit/Glan
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Gänserndorf
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Matzen, Gänserndorf, Austria, 2243
- Sport-Mittelschule Matzen-Raggendorf
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Lower Austria
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Bad Vöslau, Lower Austria, Austria, 2540
- Gymnasium Bad Vöslau/Gainfard
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Lanzenkirchen, Lower Austria, Austria, 2821
- NMS Lanzenkirchen
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Wr. Neustadt, Lower Austria, Austria, 2700
- BG/BRG Zehnergasse
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Styria
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Graz, Styria, Austria, 1230
- Bischöfliches Gymnasium Graz
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Liezen, Styria, Austria, 8940
- NMS Liezen
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Upper Austria
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Wels, Upper Austria, Austria, 4600
- BG/BRG Wels
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
11 lat do 13 lat (Dziecko)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Students in one of the recruited schools
- Appropriate knowledge of the German language
Exclusion Criteria:
- No signed consent of parent and of child
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Brak interwencji: control
the range of products offered by the vending machines remains unchanged
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Inny: Intervention group 1
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
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sugar reduction in the offered drinks
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Inny: Intervention group 2
In the second intervention group, the vending machines offer 80% water and 20% products with a maximum of 6.7g sugar/100ml.
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sugar reduction in the offered drinks
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Consumption of mean liquid free sugar intake per week (g) by using the 7-day fluid record
Ramy czasowe: 1 week
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self report of fluid consumption
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1 week
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Absolute (mL) and relative (%) contribution of each fluid intake category to total fluid intake by using the 7-day fluid record
Ramy czasowe: 1 week
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self report of fluid consumption, the measure presents only one outcome "fluid intake", which will be reported in "ml" and "%".
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1 week
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Water intake by using the 7-day fluid record with the proportion of children meeting the EFSA adequate intake for water from fluids
Ramy czasowe: 1 week
|
self report of fluid consumption
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1 week
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Consumption of free sugar from food by 24-h dietary recall
Ramy czasowe: 24 hours
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self report of food consumption
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24 hours
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Body weight and Body-Mass-Index (BMI) by using body weight and height
Ramy czasowe: Start, 3-4 months, 7-8 months
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Measured with a calibrated body scale in light clothes and without shoes
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Start, 3-4 months, 7-8 months
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Abdominal girth
Ramy czasowe: Start, 3-4 months, 7-8 months
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inelastic tape
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Start, 3-4 months, 7-8 months
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Physical activity
Ramy czasowe: Start, 3-4 months, 7-8 months
|
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
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Start, 3-4 months, 7-8 months
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Socio-demographic and socioeconomic factors
Ramy czasowe: after 7-8 months
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questionnaire, scale title "socio-demographic and socio-econimoc status", scale minimum is "0", scale maximum is "3", higher scores mean a better outcome
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after 7-8 months
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Sales data (frequencies of beverages) of the vending machine and school cafeteria operators
Ramy czasowe: through study completion, an average of 8 month
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Interview
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through study completion, an average of 8 month
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: PLoS One. 2019 Mar 27;14(3):e0214344.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Przydatne linki
- World Health Organization (WHO). Diet, nutrition and the prevention of chronic diseases: report of a Joint WHO/FAO Expert Consultation
- Sugars intake for adults and children
- Scientific Opinion on Dietary Reference Values for water
- The Family Affluence Scale as a Measure of National Wealth: Validation of an Adolescent Self-Report Measure
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
13 listopada 2019
Zakończenie podstawowe (Rzeczywisty)
30 marca 2020
Ukończenie studiów (Rzeczywisty)
30 marca 2020
Daty rejestracji na studia
Pierwszy przesłany
11 listopada 2019
Pierwszy przesłany, który spełnia kryteria kontroli jakości
14 listopada 2019
Pierwszy wysłany (Rzeczywisty)
15 listopada 2019
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
13 kwietnia 2020
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 kwietnia 2020
Ostatnia weryfikacja
1 listopada 2019
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Version 1.4
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Niezdecydowany
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .