NCT04165304

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
431

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

15 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

November 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

April 13, 2020

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

November 11, 2019

Last Update Submit

April 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Absolute (mL) and relative (%) contribution of each fluid intake category to total fluid intake by using the 7-day fluid record

    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

    1 week

  • Consumption of free sugar from food by 24-h dietary recall

    24 hours

  • Body weight and Body-Mass-Index (BMI) by using body weight and height

    Start, 3-4 months, 7-8 months

  • Abdominal girth

    Start, 3-4 months, 7-8 months

  • +3 more secondary outcomes

Study Arms (3)

control

NO INTERVENTION

the range of products offered by the vending machines remains unchanged

Intervention group 1

OTHER

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

Intervention group 2

OTHER

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

Interventions

sugar reductionDIETARY_SUPPLEMENT

sugar reduction in the offered drinks

Intervention group 1Intervention group 2

Eligibility Criteria

Age11 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Students in one of the recruited schools
  • Appropriate knowledge of the German language

You may not qualify if:

  • No signed consent of parent and of child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

NMS St. Veit/Glan

Sankt Veit an der Glan, Carinthia, 9300, Austria

Location

NMS II Spittal/Drau

Spittal an der Drau, Carinthia, 9800, Austria

Location

Sport-Mittelschule Matzen-Raggendorf

Matzen, Gänserndorf, 2243, Austria

Location

Gymnasium Bad Vöslau/Gainfard

Bad Vöslau, Lower Austria, 2540, Austria

Location

NMS Lanzenkirchen

Lanzenkirchen, Lower Austria, 2821, Austria

Location

BG/BRG Zehnergasse

Wiener Neustadt, Lower Austria, 2700, Austria

Location

Bischöfliches Gymnasium Graz

Graz, Styria, 1230, Austria

Location

NMS Liezen

Liezen, Styria, 8940, Austria

Location

BG/BRG Wels

Wels, Upper Austria, 4600, Austria

Location

GRG II Zirkusgasse

Vienna, 1020, Austria

Location

BRG Marchettigasse

Vienna, 1060, Austria

Location

GRG Gottschalkgasse

Vienna, 1110, Austria

Location

GWIKU 18 Haizingergasse

Vienna, 1180, Austria

Location

LWS Donaustadt

Vienna, 1220, Austria

Location

GRG 23

Vienna, 1230, Austria

Location

Related Publications (26)

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Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 15, 2019

Study Start

November 13, 2019

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

April 13, 2020

Record last verified: 2019-11

Locations