Water ConsumptionH2NOENCT03852173
Effects of a School-based Intervention to Increase the Water Consumption in Elementary School Children
A study testing Wasserschulen in people with Water Consumption and Drinking Behavior, run by Danube University Krems at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Water Consumption, Drinking Behavior
- What is being tested?
- Wasserschulen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,485 participants
- Where
- 1 siteAustria
- Study dates
- 7 Jun 2018to 13 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
- school children in third class of elementary school (at baseline)
- written declaration of consent by a parent/guardian
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Process and Outcome Evaluation of an Intervention to Increase the Water Consumption of Elementary School Children in Lower Austria - a Pilot Study
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.
Read the 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.
- Conditions
- Water Consumption, Drinking Behavior
- Being tested
- Wasserschulen
- Keywords
- Child, Health promotion, longitudinal studies, Surveys and Questionnaires, beverages, Water/administration & dosage, Austria, Program evaluation, Students/statistics & numerical data, Food Preferences, Follow-Up Studies, school setting, behavioural change
- Medical subject headings
- Drinking Behavior, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WasserschulenBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group "Wasserschulen" | Experimental | 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. Receives: Behavioral: Wasserschulen |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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)
Measured: baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
Secondary outcomes (7)
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
Measured: baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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
Measured: baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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
Measured: baseline, end of intervention (after one school year, 9 months), follow-up (after two school years, 21 months)
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)
Measured: end of intervention (after one school year, 9 months)
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)
Measured: end of intervention (after one school year, 9 months)
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)
Measured: end of intervention (after one school year, 9 months)
Parameters of process evaluation (acceptance)
focus group discussions with a subset of school children, teachers and school headmasters
Measured: end of intervention (after one school year, 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start7 Jun 2018
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Water ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention versus no intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danube University Krems
- Sponsor type
- University, hospital or other
- Collaborators
- Lower Austrian Health and Social Fund, Medical University of Vienna
- Responsible party
- Principal investigator, Ursula Griebler, Danube University Krems
- Investigators
- Ursula Griebler, PhD, MPH, Principal investigator, Danube University Krems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852173
- Sponsor's protocol ID
- H2NOE-Wasserschule
- Acronym
- H2NOE
- Status last verified
- Sep 2021
- First submitted
- 19 Feb 2019
- Last updated
- 13 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Griebler U, Titscher V, Weber M, Affengruber L. Evaluation of the 'H2NOE Water Schools' programme to promote water consumption in elementary schoolchildren: a non-randomised controlled cluster trial. Public Health Nutr. 2022 Jan;25(1):159-169. doi: 10.1017/S1368980021003438. Epub 2021 Aug 13.
PubMed 34384513
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Process and Outcome Evaluation of an Intervention to Increase the Water Consumption of Elementary School Children in Lower Austria - a Pilot Study
- ClinicalTrials.gov ID
- NCT03852173
- Acronym / sponsor ID
- H2NOE / H2NOE-Wasserschule
- Conditions
- Water Consumption, Drinking Behavior
- Keywords
- Child, Health promotion, longitudinal studies, Surveys and Questionnaires, beverages, Water/administration & dosage, Austria, Program evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,485 participants (actual)
- Lead sponsor
- Danube University KremsUniversity, hospital or other
- Collaborators
- Lower Austrian Health and Social Fund, Medical University of Vienna
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention versus no intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention group "Wasserschulen" | Experimental | Behavioral: WasserschulenSchools 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. |
| Control group | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- elementary school in Niederösterreich (Upper Austria, a province of Austria)
- no juice provided with the school milk programme
- school children in third class of elementary school (at baseline)
- written declaration of consent by a parent/guardian
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WasserschulenSchools 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 | Behavioural | Intervention group "Wasserschulen" |
Primary outcome
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)
consumption of tap water, in number of glasses (with 1 glass defined as 200 mL) per day/ during school time (self-report)
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)
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)
7 secondary outcomes
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)
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)
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)
Parameters of process evaluation (implementation dose)
Time frame: end of intervention (after one school year, 9 months)
Parameters of process evaluation (implementation fidelity)
Time frame: end of intervention (after one school year, 9 months)
Parameters of process evaluation (implementation reach)
Time frame: end of intervention (after one school year, 9 months)
Parameters of process evaluation (acceptance)
Time frame: end of intervention (after one school year, 9 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Results publication: PubMed 34384513Griebler U, Titscher V, Weber M, Affengruber L. Evaluation of the 'H2NOE Water Schools' programme to promote water consumption in elementary schoolchildren: a non-randomised controlled cluster trial. Public Health Nutr. 2022 Jan;25(1):159-169. doi: 10.1017/S1368980021003438. Epub 2021 Aug 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ursula Griebler, PhD, MPH principal investigator
Danube University Krems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wasserschulen in people with Water Consumption and Drinking Behavior, run by Danube University Krems at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03852173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.