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

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ClinicalTrials.gov Identifier: NCT04165304
Recruitment Status : Recruiting
First Posted : November 15, 2019
Last Update Posted : November 15, 2019
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)
Estimated Enrollment : 664 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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

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



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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


Contacts
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Contact: Manuel Schätzer, PhD +43 (0) 664 13 82 258 m.schaetzer@sipcan.at
Contact: Magdalena Pilz, PhD +43 (0) 664 889 886 46 m.pilz@sipcan.at

Locations
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Austria
Sport-Mittelschule Matzen-Raggendorf Recruiting
Matzen, Gänserndorf, Austria, 2243
Contact: Hofer         
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     History of Changes
Other Study ID Numbers: Version 1.4
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: November 15, 2019
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