Students of the 6. GradeNCT04165304
Impact on Drinking Behaviour in Sixth-grade Students Through Changing the School Environment
A study testing sugar reduction in people with Students of the 6. Grade, run by Special Institute for Preventive Cardiology And Nutrition at 15 sites in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Students of the 6. Grade
- What is being tested?
- sugar reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 15 sitesAustria
- Study dates
- 13 Nov 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students in one of the recruited schools
- Appropriate knowledge of the German language
Who cannot join
- No signed consent of parent and of child
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Austria15 sites
Gymnasium Bad Vöslau/Gainfard
Bad Vöslau, Lower Austria, 2540
Bischöfliches Gymnasium Graz
Graz, Styria, 1230
NMS Lanzenkirchen
Lanzenkirchen, Lower Austria, 2821
NMS Liezen
Liezen, Styria, 8940
Sport-Mittelschule Matzen-Raggendorf
Matzen, Gänserndorf, 2243
NMS St. Veit/Glan
Sankt Veit an der Glan, Carinthia, 9300
NMS II Spittal/Drau
Spittal an der Drau, Carinthia, 9800
GRG II Zirkusgasse
Vienna, 1020
BRG Marchettigasse
Vienna, 1060
GRG Gottschalkgasse
Vienna, 1110
GWIKU 18 Haizingergasse
Vienna, 1180
LWS Donaustadt
Vienna, 1220
GRG 23
Vienna, 1230
BG/BRG Wels
Wels, Upper Austria, 4600
BG/BRG Zehnergasse
Wiener Neustadt, Lower Austria, 2700
About this study
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.
Read the detailed description
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.
- Conditions
- Students of the 6. Grade
- Being tested
- sugar reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugar reductionDietary supplement
sugar reduction in the offered drinks
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | the range of products offered by the vending machines remains unchanged |
| Intervention group 1 | Other | 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 Receives: Dietary Supplement: sugar reduction |
| Intervention group 2 | Other | In the second intervention group, the vending machines offer 80% water and 20% products with a maximum of 6.7g sugar/100ml. Receives: Dietary Supplement: sugar reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of mean liquid free sugar intake per week (g) by using the 7-day fluid record
self report of fluid consumption
Measured: 1 week
Secondary outcomes (8)
Absolute (mL) and relative (%) contribution of each fluid intake category to total fluid intake by using the 7-day fluid record
self report of fluid consumption, the measure presents only one outcome "fluid intake", which will be reported in "ml" and "%".
Measured: 1 week
Water intake by using the 7-day fluid record with the proportion of children meeting the EFSA adequate intake for water from fluids
self report of fluid consumption
Measured: 1 week
Consumption of free sugar from food by 24-h dietary recall
self report of food consumption
Measured: 24 hours
Body weight and Body-Mass-Index (BMI) by using body weight and height
Measured with a calibrated body scale in light clothes and without shoes
Measured: Start, 3-4 months, 7-8 months
Abdominal girth
inelastic tape
Measured: Start, 3-4 months, 7-8 months
Physical activity
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
Measured: Start, 3-4 months, 7-8 months
Socio-demographic and socioeconomic factors
questionnaire, scale title "socio-demographic and socio-econimoc status", scale minimum is "0", scale maximum is "3", higher scores mean a better outcome
Measured: after 7-8 months
Sales data (frequencies of beverages) of the vending machine and school cafeteria operators
Interview
Measured: through study completion, an average of 8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start13 Nov 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Why it stopped: Since schools are closed due to the current corona virus situation, the study cannot be continued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Students of the 6. GradeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Special Institute for Preventive Cardiology And Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165304
- Sponsor's protocol ID
- Version 1.4
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2019
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20646222Duffey 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.
PubMed 27367719McGuire 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.
PubMed 22332062Han 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.
PubMed 23260723Luger 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.
PubMed 29237159Malik 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.
PubMed 23966427Te 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.
PubMed 23321486Ma 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.
PubMed 26777597Greenwood 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.
PubMed 24932880Marshall 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.
PubMed 12949310Wilder 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.
PubMed 26339945Basu 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.
PubMed 23488503Singh 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.
PubMed 26244332Singh 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.
PubMed 26124185Reichelt 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.
PubMed 25776039
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Drinking Behaviour in Sixth-grade Students Through Changing the School Environment
- ClinicalTrials.gov ID
- NCT04165304
- Acronym / sponsor ID
- Version 1.4
- Conditions
- Students of the 6. Grade
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Since schools are closed due to the current corona virus situation, the study cannot be continued.
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Special Institute for Preventive Cardiology And NutritionUniversity, hospital or other
- Collaborators
- Danone Global Research & Innovation Center
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –the range of products offered by the vending machines remains unchanged |
| Intervention group 1 | Other | Dietary Supplement: sugar reductionvending 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 |
| Intervention group 2 | Other | Dietary Supplement: sugar reductionIn the second intervention group, the vending machines offer 80% water and 20% products with a maximum of 6.7g sugar/100ml. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Students in one of the recruited schools
- Appropriate knowledge of the German language
Key exclusion criteria (1 listed)
- No signed consent of parent and of child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sugar reductionsugar reduction in the offered drinks | Dietary supplement | Intervention group 1, Intervention group 2 |
Primary outcome
Consumption of mean liquid free sugar intake per week (g) by using the 7-day fluid record
Time frame: 1 week
self report of fluid consumption
8 secondary outcomes
Absolute (mL) and relative (%) contribution of each fluid intake category to total fluid intake by using the 7-day fluid record
Time frame: 1 week
Water intake by using the 7-day fluid record with the proportion of children meeting the EFSA adequate intake for water from fluids
Time frame: 1 week
Consumption of free sugar from food by 24-h dietary recall
Time frame: 24 hours
Body weight and Body-Mass-Index (BMI) by using body weight and height
Time frame: Start, 3-4 months, 7-8 months
Abdominal girth
Time frame: Start, 3-4 months, 7-8 months
Physical activity
Time frame: Start, 3-4 months, 7-8 months
Socio-demographic and socioeconomic factors
Time frame: after 7-8 months
Sales data (frequencies of beverages) of the vending machine and school cafeteria operators
Time frame: through study completion, an average of 8 month
Results and safety
The study was stopped early (reason given: Since schools are closed due to the current corona virus situation, the study cannot be continued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Background: PubMed 20646222Popkin 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.
- Background: PubMed 27367719Duffey 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.
- Background: PubMed 22332062McGuire 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.
- Background: PubMed 23260723Han 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.
- Background: PubMed 29237159Luger 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.
- Background: PubMed 23966427Malik 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.
- Background: PubMed 23321486Te 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.
- Background: PubMed 26777597Ma 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.
- Background: PubMed 24932880Greenwood 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.
- Background: PubMed 12949310Marshall 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.
- Background: PubMed 26339945Wilder 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.
- Background: PubMed 23488503Basu 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.
- World Health Organization (WHO). Diet, nutrition and the prevention of chronic diseases: report of a Joint WHO/FAO Expert ConsultationLink provided by the sponsor.
- Sugars intake for adults and childrenLink provided by the sponsor.
- Scientific Opinion on Dietary Reference Values for waterLink provided by the sponsor.
- The Family Affluence Scale as a Measure of National Wealth: Validation of an Adolescent Self-Report MeasureLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sugar reduction in people with Students of the 6. Grade, run by Special Institute for Preventive Cardiology And Nutrition at 15 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Since schools are closed due to the current corona virus situation, the study cannot be continued.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption of mean liquid free sugar intake per week (g) by using the 7-day fluid record (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04165304, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.