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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04165304
Other study ID # Version 1.4
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 13, 2019
Est. completion date March 30, 2020

Study information

Verified date November 2019
Source Special Institute for Preventive Cardiology And Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 431
Est. completion date March 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 13 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
sugar reduction
sugar reduction in the offered drinks

Locations

Country Name City State
Austria Gymnasium Bad Vöslau/Gainfard Bad Vöslau Lower Austria
Austria Bischöfliches Gymnasium Graz Graz Styria
Austria NMS Lanzenkirchen Lanzenkirchen Lower Austria
Austria NMS Liezen Liezen Styria
Austria Sport-Mittelschule Matzen-Raggendorf Matzen Gänserndorf
Austria NMS II Spittal/Drau Spittal An Der Drau Carinthia
Austria NMS St. Veit/Glan St. Veit an der Glan Carinthia
Austria BRG Marchettigasse Vienna
Austria GRG 23 Vienna
Austria GRG Gottschalkgasse Vienna
Austria GRG II Zirkusgasse Vienna
Austria GWIKU 18 Haizingergasse Vienna
Austria LWS Donaustadt Vienna
Austria BG/BRG Wels Wels Upper Austria
Austria BG/BRG Zehnergasse Wr. Neustadt Lower Austria

Sponsors (2)

Lead Sponsor Collaborator
Special Institute for Preventive Cardiology And Nutrition Danone Research

Country where clinical trial is conducted

Austria, 

References & Publications (26)

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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. — View Citation

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* Note: There are 26 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Consumption of mean liquid free sugar intake per week (g) by using the 7-day fluid record self report of fluid consumption 1 week
Secondary 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 "%". 1 week
Secondary 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 1 week
Secondary Consumption of free sugar from food by 24-h dietary recall self report of food consumption 24 hours
Secondary 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 Start, 3-4 months, 7-8 months
Secondary Abdominal girth inelastic tape Start, 3-4 months, 7-8 months
Secondary 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 Start, 3-4 months, 7-8 months
Secondary 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 after 7-8 months
Secondary Sales data (frequencies of beverages) of the vending machine and school cafeteria operators Interview through study completion, an average of 8 month