Impact on Drinking Behaviour in Sixth-grade Students Through Changing the School Environment

Students of the 6. Grade Clinical Trial

Official title:

Impact on Drinking Behaviour in Sixth-grade Students Through Changing the School Environment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04165304
• Other study ID #: Version 1.4
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Drinking Behavior
• Students of the 6. Grade

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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* Note: There are 26 references in all — Click 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

External Links

•   Reducing consumption of sugar-sweetened beverages to reduce the risk of childhood overweight and obesity
•   Scientific Opinion on Dietary Reference Values for water
•   Sugars intake for adults and children
•   The Family Affluence Scale as a Measure of National Wealth: Validation of an Adolescent Self-Report Measure
•   World Health Organization (WHO). Diet, nutrition and the prevention of chronic diseases: report of a Joint WHO/FAO Expert Consultation