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

April 9, 2020 updated by: Special Institute for Preventive Cardiology And Nutrition
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

431

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1020
        • GRG II Zirkusgasse
      • Vienna, Austria, 1060
        • BRG Marchettigasse
      • Vienna, Austria, 1110
        • GRG Gottschalkgasse
      • Vienna, Austria, 1180
        • GWIKU 18 Haizingergasse
      • Vienna, Austria, 1220
        • LWS Donaustadt
      • Vienna, Austria, 1230
        • GRG 23
    • Carinthia
      • Spittal An Der Drau, Carinthia, Austria, 9800
        • NMS II Spittal/Drau
      • St. Veit an der Glan, Carinthia, Austria, 9300
        • NMS St. Veit/Glan
    • Gänserndorf
      • Matzen, Gänserndorf, Austria, 2243
        • Sport-Mittelschule Matzen-Raggendorf
    • Lower Austria
      • Bad Vöslau, Lower Austria, Austria, 2540
        • Gymnasium Bad Vöslau/Gainfard
      • Lanzenkirchen, Lower Austria, Austria, 2821
        • NMS Lanzenkirchen
      • Wr. Neustadt, Lower Austria, Austria, 2700
        • BG/BRG Zehnergasse
    • Styria
      • Graz, Styria, Austria, 1230
        • Bischöfliches Gymnasium Graz
      • Liezen, Styria, Austria, 8940
        • NMS Liezen
    • Upper Austria
      • Wels, Upper Austria, Austria, 4600
        • BG/BRG Wels

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
the range of products offered by the vending machines remains unchanged
Other: Intervention group 1
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
sugar reduction in the offered drinks
Other: Intervention group 2
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
sugar reduction in the offered drinks

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
Time Frame: 1 week
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
Time Frame: 1 week
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
Time Frame: 1 week
self report of fluid consumption
1 week
Consumption of free sugar from food by 24-h dietary recall
Time Frame: 24 hours
self report of food consumption
24 hours
Body weight and Body-Mass-Index (BMI) by using body weight and height
Time Frame: Start, 3-4 months, 7-8 months
Measured with a calibrated body scale in light clothes and without shoes
Start, 3-4 months, 7-8 months
Abdominal girth
Time Frame: Start, 3-4 months, 7-8 months
inelastic tape
Start, 3-4 months, 7-8 months
Physical activity
Time Frame: Start, 3-4 months, 7-8 months
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
Time Frame: after 7-8 months
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
Time Frame: through study completion, an average of 8 month
Interview
through study completion, an average of 8 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Special Institute for Preventive Cardiology And Nutrition

Collaborators

Danone Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2019

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 1.4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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