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

Primary Purpose

Students of the 6. Grade

Status
Terminated
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
sugar reduction
Sponsored by
Special Institute for Preventive Cardiology And Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Students of the 6. Grade

Eligibility Criteria

11 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NMS II Spittal/Drau
  • NMS St. Veit/Glan
  • Sport-Mittelschule Matzen-Raggendorf
  • Gymnasium Bad Vöslau/Gainfard
  • NMS Lanzenkirchen
  • BG/BRG Zehnergasse
  • Bischöfliches Gymnasium Graz
  • NMS Liezen
  • BG/BRG Wels
  • GRG II Zirkusgasse
  • BRG Marchettigasse
  • GRG Gottschalkgasse
  • GWIKU 18 Haizingergasse
  • LWS Donaustadt
  • GRG 23

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Other

Other

Arm Label

control

Intervention group 1

Intervention group 2

Arm Description

the range of products offered by the vending machines remains unchanged

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 and 20% products with a maximum of 6.7g sugar/100ml.

Outcomes

Primary Outcome Measures

Consumption of mean liquid free sugar intake per week (g) by using the 7-day fluid record
self report of fluid consumption

Secondary Outcome Measures

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 "%".
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
Consumption of free sugar from food by 24-h dietary recall
self report of food consumption
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
Abdominal girth
inelastic tape
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
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
Sales data (frequencies of beverages) of the vending machine and school cafeteria operators
Interview

Full Information

First Posted
November 11, 2019
Last Updated
April 9, 2020
Sponsor
Special Institute for Preventive Cardiology And Nutrition
Collaborators
Danone Research
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1. Study Identification

Unique Protocol Identification Number
NCT04165304
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Since schools are closed due to the current corona virus situation, the study cannot be continued.
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Special Institute for Preventive Cardiology And Nutrition
Collaborators
Danone Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Students of the 6. Grade

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
431 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
the range of products offered by the vending machines remains unchanged
Arm Title
Intervention group 1
Arm Type
Other
Arm Description
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
Arm Title
Intervention group 2
Arm Type
Other
Arm Description
In the second intervention group, the vending machines offer 80% water and 20% products with a maximum of 6.7g sugar/100ml.
Intervention Type
Dietary Supplement
Intervention Name(s)
sugar reduction
Intervention Description
sugar reduction in the offered drinks
Primary Outcome Measure Information:
Title
Consumption of mean liquid free sugar intake per week (g) by using the 7-day fluid record
Description
self report of fluid consumption
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Absolute (mL) and relative (%) contribution of each fluid intake category to total fluid intake by using the 7-day fluid record
Description
self report of fluid consumption, the measure presents only one outcome "fluid intake", which will be reported in "ml" and "%".
Time Frame
1 week
Title
Water intake by using the 7-day fluid record with the proportion of children meeting the EFSA adequate intake for water from fluids
Description
self report of fluid consumption
Time Frame
1 week
Title
Consumption of free sugar from food by 24-h dietary recall
Description
self report of food consumption
Time Frame
24 hours
Title
Body weight and Body-Mass-Index (BMI) by using body weight and height
Description
Measured with a calibrated body scale in light clothes and without shoes
Time Frame
Start, 3-4 months, 7-8 months
Title
Abdominal girth
Description
inelastic tape
Time Frame
Start, 3-4 months, 7-8 months
Title
Physical activity
Description
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
Time Frame
Start, 3-4 months, 7-8 months
Title
Socio-demographic and socioeconomic factors
Description
questionnaire, scale title "socio-demographic and socio-econimoc status", scale minimum is "0", scale maximum is "3", higher scores mean a better outcome
Time Frame
after 7-8 months
Title
Sales data (frequencies of beverages) of the vending machine and school cafeteria operators
Description
Interview
Time Frame
through study completion, an average of 8 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
NMS II Spittal/Drau
City
Spittal An Der Drau
State/Province
Carinthia
ZIP/Postal Code
9800
Country
Austria
Facility Name
NMS St. Veit/Glan
City
St. Veit an der Glan
State/Province
Carinthia
ZIP/Postal Code
9300
Country
Austria
Facility Name
Sport-Mittelschule Matzen-Raggendorf
City
Matzen
State/Province
Gänserndorf
ZIP/Postal Code
2243
Country
Austria
Facility Name
Gymnasium Bad Vöslau/Gainfard
City
Bad Vöslau
State/Province
Lower Austria
ZIP/Postal Code
2540
Country
Austria
Facility Name
NMS Lanzenkirchen
City
Lanzenkirchen
State/Province
Lower Austria
ZIP/Postal Code
2821
Country
Austria
Facility Name
BG/BRG Zehnergasse
City
Wr. Neustadt
State/Province
Lower Austria
ZIP/Postal Code
2700
Country
Austria
Facility Name
Bischöfliches Gymnasium Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
1230
Country
Austria
Facility Name
NMS Liezen
City
Liezen
State/Province
Styria
ZIP/Postal Code
8940
Country
Austria
Facility Name
BG/BRG Wels
City
Wels
State/Province
Upper Austria
ZIP/Postal Code
4600
Country
Austria
Facility Name
GRG II Zirkusgasse
City
Vienna
ZIP/Postal Code
1020
Country
Austria
Facility Name
BRG Marchettigasse
City
Vienna
ZIP/Postal Code
1060
Country
Austria
Facility Name
GRG Gottschalkgasse
City
Vienna
ZIP/Postal Code
1110
Country
Austria
Facility Name
GWIKU 18 Haizingergasse
City
Vienna
ZIP/Postal Code
1180
Country
Austria
Facility Name
LWS Donaustadt
City
Vienna
ZIP/Postal Code
1220
Country
Austria
Facility Name
GRG 23
City
Vienna
ZIP/Postal Code
1230
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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The Family Affluence Scale as a Measure of National Wealth: Validation of an Adolescent Self-Report Measure

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

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