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

Study Overview
=================
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.

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

Conditions
-----------------
Students of the 6. Grade

Intervention / Treatment
-----------------
* Dietary Supplement: sugar reduction


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>the range of products offered by the vending machines remains unchanged | |
| Other: Intervention group 1<br>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 | Dietary Supplement: sugar reduction<br>* sugar reduction in the offered drinks<br>|
| Other: Intervention group 2<br>In the second intervention group, the vending machines offer 80% water and 20% products with a maximum of 6.7g sugar/100ml. | Dietary Supplement: sugar reduction<br>* sugar reduction in the offered drinks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Consumption of free sugar from food by 24-h dietary recall | self report of food consumption | 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 | Start, 3-4 months, 7-8 months | 
| Abdominal girth | inelastic tape | 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 | 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 | after 7-8 months | 
| Sales data (frequencies of beverages) of the vending machine and school cafeteria operators | Interview | through study completion, an average of 8 month |