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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04165304
Recruitment Status : Terminated (Since schools are closed due to the current corona virus situation, the study cannot be continued.)
First Posted : November 15, 2019
Last Update Posted : April 13, 2020
Sponsor:
Collaborator:
Danone Research
Information provided by (Responsible Party):
Special Institute for Preventive Cardiology And Nutrition

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.

Condition or disease Intervention/treatment Phase
Students of the 6. Grade Dietary Supplement: sugar reduction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 431 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact on Drinking Behaviour in Sixth-grade Students Through Changing the School Environment
Actual Study Start Date : November 13, 2019
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : March 30, 2020

Arm Intervention/treatment
No Intervention: control
the range of products offered by the vending machines remains unchanged
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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 "%".

  2. 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

  3. Consumption of free sugar from food by 24-h dietary recall [ Time Frame: 24 hours ]
    self report of food consumption

  4. 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

  5. Abdominal girth [ Time Frame: Start, 3-4 months, 7-8 months ]
    inelastic tape

  6. 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

  7. 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

  8. Sales data (frequencies of beverages) of the vending machine and school cafeteria operators [ Time Frame: through study completion, an average of 8 month ]
    Interview



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165304


Locations
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Austria
NMS II Spittal/Drau
Spittal An Der Drau, Carinthia, Austria, 9800
NMS St. Veit/Glan
St. Veit an der Glan, Carinthia, Austria, 9300
Sport-Mittelschule Matzen-Raggendorf
Matzen, Gänserndorf, Austria, 2243
Gymnasium Bad Vöslau/Gainfard
Bad Vöslau, Lower Austria, Austria, 2540
NMS Lanzenkirchen
Lanzenkirchen, Lower Austria, Austria, 2821
BG/BRG Zehnergasse
Wr. Neustadt, Lower Austria, Austria, 2700
Bischöfliches Gymnasium Graz
Graz, Styria, Austria, 1230
NMS Liezen
Liezen, Styria, Austria, 8940
BG/BRG Wels
Wels, Upper Austria, Austria, 4600
GRG II Zirkusgasse
Vienna, Austria, 1020
BRG Marchettigasse
Vienna, Austria, 1060
GRG Gottschalkgasse
Vienna, Austria, 1110
GWIKU 18 Haizingergasse
Vienna, Austria, 1180
LWS Donaustadt
Vienna, Austria, 1220
GRG 23
Vienna, Austria, 1230
Sponsors and Collaborators
Special Institute for Preventive Cardiology And Nutrition
Danone Research
Additional Information:
Publications:

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Responsible Party: Special Institute for Preventive Cardiology And Nutrition
ClinicalTrials.gov Identifier: NCT04165304    
Other Study ID Numbers: Version 1.4
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drinking Behavior