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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03852173
Other study ID # H2NOE-Wasserschule
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 7, 2018
Est. completion date July 13, 2020

Study information

Verified date September 2021
Source Danube University Krems
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this controlled intervention study is to evaluate the effectiveness of a school-based intervention aiming at increasing the water consumption in elementary school children. The intervention schools received refillable water bottles and drying racks for all school children as well as educational material. The focus of the intervention is the promotion of drinking tap water.


Description:

This pilot project, called "H2NOE-Wasserschulen" (Water Schools in Lower Austria), aims to increase the water consumption of school children in elementary schools, to raise awareness of water drinking in children, parents and school teachers and to promote water drinking in Lower Austria in general. By increasing the consumption of water, the consumption of sugar-sweetened beverages may decrease and in the long run may have a positive impact on children's body weight and tooth status. All intervention schools receive refillable water bottles for each school child and drying racks for each classroom. Furthermore, in each school an information session for all school teachers is held and the teachers receive prepared educational material. The control schools do not receive the water bottles nor the educational material. For the study, the investigators recruited 22 intervention schools and 32 control schools. Outcomes will be measured by paper and pencil questionnaires of school children at third grade of participating elementary schools in Lower Austria and with online questionnaires of teachers at baseline, at the end of the intervention (after one school year/June 2019) and at the one-year follow-up (after two school years/June 2020). For process evaluation outcomes, the investigators will carry out focus group discussions with a subsample of school children and teachers and include questions in the respective questionnaires for school children, teachers and school headmasters. Parents will have the possibility to give feedback online.


Recruitment information / eligibility

Status Completed
Enrollment 1485
Est. completion date July 13, 2020
Est. primary completion date July 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility For the intervention schools: Inclusion criteria: - elementary school in Niederösterreich (Upper Austria, a province of Austria) - no juice provided with the school milk programme For the school children taking part in the survey: Inclusion criteria: - school children in third class of elementary school (at baseline) - written declaration of consent by a parent/guardian

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Wasserschulen
Schools receive following materials and trainings: one training sessions for teachers (at the beginning of the intervention) refillable water bottles for each school student drying rack for water bottles for each classroom educational material for each class and for school events informational material for parents

Locations

Country Name City State
Austria Lower Austrian Health and Social Fund St. Pölten

Sponsors (3)

Lead Sponsor Collaborator
Danube University Krems Lower Austrian Health and Social Fund, Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Griebler U, Titscher V, Weber M, Affengruber L. Evaluation of the 'H2NOE Water Schools' programme to promote water consumption in elementary school children - a non-randomised controlled cluster trial. Public Health Nutr. 2021 Aug 13:1-24. doi: 10.1017/S1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in water consumption of school children (from baseline to post-intervention and follow-up) consumption of tap water, in number of glasses (with 1 glass defined as 200 mL) per day/ during school time (self-report) baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
Primary Change of attitude of school children towards drinking water (from baseline to post-intervention and follow-up) preference for water and sugar-sweetened beverages (measured as agreement to various statements regarding water and sugar-sweetened beverage consumption with 5 likert-scale answer categories: yes, that's right; yes, mostly; no, mostly not; no, not true; I don't know) baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
Secondary Change in beverage consumption of school children (from baseline to post-intervention and follow-up) consumption of tap water, mineral water, fruit- and herbal tea, milk and cacao, soft drinks (lemonade, cola and iced tea), juice and juice with water; in number of glasses (with 1 glass defined as 200 mL) for the last 24h baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
Secondary Change in food consumption of school children (from baseline to post-intervention and follow-up) consumption of fruit and berries; vegetables (raw or cooked); sweets, chocolate or ice-cream; soft drinks (lemonade, cola and iced tea); fast food (french fries, chicken nuggets, pizza, McDonald's, sausages); salty snacks (crisps, popcorn, salted pretzel sticks); frequency of consumption during a normal week, when thinking of the last weeks baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
Secondary Change in breakfast consumption of school children (from baseline to post-intervention and follow-up) frequency of eating breakfast during school days and on the weekend baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
Secondary Parameters of process evaluation (implementation dose) frequency of addressing the topic water during regular lessons, implementation of classroom rules for water drinking, extent of water bottle use of school children; by online questionnaire (all teachers from intervention schools); extent of water bottle use, by paper and pencil questionnaire (all school children from intervention schools); number of interventional material distributed in school; by online questionnaire (all headmasters from intervention schools) end of intervention (after one school year, 9 months)
Secondary Parameters of process evaluation (implementation fidelity) implementation of classroom rules for water drinking; extent of information for parents; by online questionnaire (all teachers from intervention schools) end of intervention (after one school year, 9 months)
Secondary Parameters of process evaluation (implementation reach) proportion of classes that implemented the intervention, information about intervention on the school homepage, number of interventional material distributed in school; by online questionnaire (all headmasters from intervention schools); extent of information for parents; by online questionnaire (all teachers from intervention schools) end of intervention (after one school year, 9 months)
Secondary Parameters of process evaluation (acceptance) focus group discussions with a subset of school children, teachers and school headmasters end of intervention (after one school year, 9 months)
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