- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03852173
Effects of a School-based Intervention to Increase the Water Consumption in Elementary School Children (H2NOE)
Process and Outcome Evaluation of an Intervention to Increase the Water Consumption of Elementary School Children in Lower Austria - a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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St. Pölten, Austria, 3100
- Lower Austrian Health and Social Fund
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group "Wasserschulen"
Schools receive refillable drinking bottles for all school children and drying racks for each classroom.
Schools receive special project educational material and informational material and one training session for teachers.
The intervention will be implemented during one school year (2018/2019), but schools can use the material and bottles also after ending of the intervention period.
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Schools receive following materials and trainings:
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NO_INTERVENTION: Control group
No intervention (usual education).
Schools do not receive any project material.
Schools got the information that they are part of a study on drinking and eating habits of third grade elementary school children.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in water consumption of school children (from baseline to post-intervention and follow-up)
Time Frame: baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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consumption of tap water, in number of glasses (with 1 glass defined as 200 mL) per day/ during school time (self-report)
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baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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Change of attitude of school children towards drinking water (from baseline to post-intervention and follow-up)
Time Frame: baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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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)
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baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in beverage consumption of school children (from baseline to post-intervention and follow-up)
Time Frame: baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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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
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baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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Change in food consumption of school children (from baseline to post-intervention and follow-up)
Time Frame: baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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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
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baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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Change in breakfast consumption of school children (from baseline to post-intervention and follow-up)
Time Frame: baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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frequency of eating breakfast during school days and on the weekend
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baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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Parameters of process evaluation (implementation dose)
Time Frame: end of intervention (after one school year, 9 months)
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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)
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end of intervention (after one school year, 9 months)
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Parameters of process evaluation (implementation fidelity)
Time Frame: end of intervention (after one school year, 9 months)
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implementation of classroom rules for water drinking; extent of information for parents; by online questionnaire (all teachers from intervention schools)
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end of intervention (after one school year, 9 months)
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Parameters of process evaluation (implementation reach)
Time Frame: end of intervention (after one school year, 9 months)
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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)
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end of intervention (after one school year, 9 months)
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Parameters of process evaluation (acceptance)
Time Frame: end of intervention (after one school year, 9 months)
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focus group discussions with a subset of school children, teachers and school headmasters
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end of intervention (after one school year, 9 months)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ursula Griebler, PhD, MPH, Danube University Krems
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2NOE-Wasserschule
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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