Clinical trial NCT04165304: Impact on Drinking Behaviour in Sixth-grade Students Through Changing the School Environment
Official title: Impact on Drinking Behaviour in Sixth-grade Students Through Changing the School Environment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Students of the 6. Grade
Lead sponsor: Special Institute for Preventive Cardiology And Nutrition
Sponsor class: OTHER
Collaborators: name: Danone Global Research & Innovation Center
First posted: 2019-11-15
Enrollment: 431
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Consumption of mean liquid free sugar intake per week (g) by using the 7-day fluid record
timeFrame: 1 week
Secondary outcomes:
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
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
measure: Consumption of free sugar from food by 24-h dietary recall
timeFrame: 24 hours
measure: Body weight and Body-Mass-Index (BMI) by using body weight and height
timeFrame: Start, 3-4 months, 7-8 months
measure: Abdominal girth
timeFrame: Start, 3-4 months, 7-8 months
measure: Physical activity
timeFrame: Start, 3-4 months, 7-8 months
measure: Socio-demographic and socioeconomic factors
timeFrame: after 7-8 months
measure: Sales data (frequencies of beverages) of the vending machine and school cafeteria operators
timeFrame: through study completion, an average of 8 month
Other outcomes:
Locations:
city: Spittal An Der Drau
country: Austria
facility: NMS II Spittal/Drau
state: Carinthia
city: St. Veit an der Glan
country: Austria
facility: NMS St. Veit/Glan
state: Carinthia
city: Matzen
country: Austria
facility: Sport-Mittelschule Matzen-Raggendorf
state: Gänserndorf
city: Bad Vöslau
country: Austria
facility: Gymnasium Bad Vöslau/Gainfard
state: Lower Austria
city: Lanzenkirchen
country: Austria
facility: NMS Lanzenkirchen
state: Lower Austria
city: Wr. Neustadt
country: Austria
facility: BG/BRG Zehnergasse
state: Lower Austria
city: Graz
country: Austria
facility: Bischöfliches Gymnasium Graz
state: Styria
city: Liezen
country: Austria
facility: NMS Liezen
state: Styria
city: Wels
country: Austria
facility: BG/BRG Wels
state: Upper Austria
city: Vienna
country: Austria
facility: GRG II Zirkusgasse
city: Vienna
country: Austria
facility: BRG Marchettigasse
city: Vienna
country: Austria
facility: GRG Gottschalkgasse
city: Vienna
country: Austria
facility: GWIKU 18 Haizingergasse
city: Vienna
country: Austria
facility: LWS Donaustadt
city: Vienna
country: Austria
facility: GRG 23
Study officials:
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