OverweighttrinkfitNCT00554294
Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
A study testing environmental and behavioral change in people with Overweight, run by Research Institute of Child Nutrition, Dortmund.
Trial summary
A major goal in public health is to find effective, feasible and simple programs for overweight prevention among children. This controlled intervention study evaluates a simple environmental and behavioral modification for its efficacy in preventing overweight of children in the school setting. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- environmental and behavioral change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,950 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children in 2nd and 3rd grade of selected elementary schools
Who cannot join
- parental consent
About this study
A major goal in public health is to find effective, feasible and simple programs for overweight prevention among children. This controlled intervention study evaluates a simple environmental and behavioral modification for its efficacy in preventing overweight of children in the school setting. The intervention strategy focuses solely on the promotion of drinking tap water. The study was conducted in 32 elementary schools including about 3000 children in two German cities over 1 school year.
Read the detailed description
Soft drinks and other caloric beverages are supposed to be involved in the development of overweight and obesity in children. The intervention strategy of our study was to promote water consumption by facilitating access to tap water in schools assuming a concomitant decrease in caloric soft drinks at least at school. The environmental modification of installing a water dispenser at school and delivering a special bottle to each child in the intervention schools was supported by a few educational lessons. These lessons were held by the class teachers who received a prepared 6-hour curriculum dealing with the importance of water for the body and of water intake. For the study 17 randomly selected schools were assigned to the intervention group, 15 schools to the control group that did not receive any intervention. Body weight and height to calculate BMI as primary outcome were assessed at baseline and after the intervention period of 1 school year. As secondary outcome drinking and physical activity habits were evaluated at baseline and after the intervention. The water flow of the dispenser was measured at regular intervals. In addition, data of process evaluation was collected to measure acceptance and feasibility of the intervention in the school setting.
To analyze the efficacy of this primarily environmental and behavioral intervention, incidence and prevalence was compared between intervention and control group.
- Conditions
- Overweight
- Being tested
- environmental and behavioral change
- Keywords
- children, primary prevention, environmental change, behavioural change, school setting, changing of drinking habits, promotion of drinking tap water
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
environmental and behavioral changeBehavioural
In intervention schools a water dispenser was installed and children received water bottles as environmental intervention. Children also received a 6-hour-curriculum about the importance of water for the body that were held by the teachers.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control schools had school curriculum as usual and did not receive environmental intervention. |
| Intervention group | Experimental | Intervention schools received water dispensers, drinking bottles and lessons as intervention. Receives: Behavioral: environmental and behavioral change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overweight
Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)
Measured: one school year
Secondary outcomes (4)
Intake of Drinks
Measured: one school year
Physical Activity and Inactivity
Measured: one school year
Water Flow of the Water Dispensers
Measured: one school year
Parameters of Process Evaluation (Acceptance, Feasibility)
Measured: 1,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startApr 2006
- Primary completionJun 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute of Child Nutrition, Dortmund
- Sponsor type
- University, hospital or other
- Investigators
- Mathilde Kersting, PhD, Principal investigator, Research Insitute of Child Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554294
- Sponsor's protocol ID
- 05HS026
- Acronym
- trinkfit
- Status last verified
- May 2009
- First submitted
- 5 Nov 2007
- Last updated
- 16 Jul 2009
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Promotion and provision of drinking water in schools for overweight prevention: randomized, controlled cluster trial. Pediatrics. 2009 Apr;123(4):e661-7. doi: 10.1542/peds.2008-2186.
PubMed 19336356Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Immigrational background affects the effectiveness of a school-based overweight prevention program promoting water consumption. Obesity (Silver Spring). 2010 Mar;18(3):528-34. doi: 10.1038/oby.2009.270. Epub 2009 Aug 27.
PubMed 19713953
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Water Consumption for Prevention of Overweight in School Children in a Controlled Intervention Trial
- ClinicalTrials.gov ID
- NCT00554294
- Acronym / sponsor ID
- trinkfit / 05HS026
- Conditions
- Overweight
- Keywords
- children, primary prevention, environmental change, behavioural change, school setting, changing of drinking habits, promotion of drinking tap water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,950 participants (actual)
- Lead sponsor
- Research Institute of Child Nutrition, DortmundUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Nov 2007 (estimated)
- Results
- Posted 16 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A major goal in public health is to find effective, feasible and simple programs for overweight prevention among children. This controlled intervention study evaluates a simple environmental and behavioral modification for its efficacy in preventing overweight of children in the school setting. The intervention strategy focuses solely on the promotion of drinking tap water. The study was conducted in 32 elementary schools including about 3000 children in two German cities over 1 school year.
Detailed description
Soft drinks and other caloric beverages are supposed to be involved in the development of overweight and obesity in children. The intervention strategy of our study was to promote water consumption by facilitating access to tap water in schools assuming a concomitant decrease in caloric soft drinks at least at school. The environmental modification of installing a water dispenser at school and delivering a special bottle to each child in the intervention schools was supported by a few educational lessons. These lessons were held by the class teachers who received a prepared 6-hour curriculum dealing with the importance of water for the body and of water intake. For the study 17 randomly selected schools were assigned to the intervention group, 15 schools to the control group that did not receive any intervention. Body weight and height to calculate BMI as primary outcome were assessed at baseline and after the intervention period of 1 school year. As secondary outcome drinking and physical activity habits were evaluated at baseline and after the intervention. The water flow of the dispenser was measured at regular intervals. In addition, data of process evaluation was collected to measure acceptance and feasibility of the intervention in the school setting.
To analyze the efficacy of this primarily environmental and behavioral intervention, incidence and prevalence was compared between intervention and control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control schools had school curriculum as usual and did not receive environmental intervention. |
| Intervention group | Experimental | Behavioral: environmental and behavioral changeIntervention schools received water dispensers, drinking bottles and lessons as intervention. |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children in 2nd and 3rd grade of selected elementary schools
Key exclusion criteria (1 listed)
- parental consent
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 |
|---|---|---|
| environmental and behavioral changeIn intervention schools a water dispenser was installed and children received water bottles as environmental intervention. Children also received a 6-hour-curriculum about the importance of water for the body that were held by the teachers. | Behavioural | Intervention group |
Primary outcome
Overweight
Time frame: one school year
Prevalence of overweight defined acording to the criteria of the International Obesity Task Force (IOTF)
4 secondary outcomes
Intake of Drinks
Time frame: one school year
Physical Activity and Inactivity
Time frame: one school year
Water Flow of the Water Dispensers
Time frame: one school year
Parameters of Process Evaluation (Acceptance, Feasibility)
Time frame: 1,5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19336356Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Promotion and provision of drinking water in schools for overweight prevention: randomized, controlled cluster trial. Pediatrics. 2009 Apr;123(4):e661-7. doi: 10.1542/peds.2008-2186.
- Derived from this study: PubMed 19713953Muckelbauer R, Libuda L, Clausen K, Toschke AM, Reinehr T, Kersting M. Immigrational background affects the effectiveness of a school-based overweight prevention program promoting water consumption. Obesity (Silver Spring). 2010 Mar;18(3):528-34. doi: 10.1038/oby.2009.270. Epub 2009 Aug 27.
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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.
Mathilde Kersting, PhD principal investigator
Research Insitute of Child Nutrition
Questions about this trial
What is this clinical trial studying?
A study testing environmental and behavioral change in people with Overweight, run by Research Institute of Child Nutrition, Dortmund.
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 1 inclusion and 1 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 16 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 16 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overweight (time frame: one school year). 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 NCT00554294, which also lists 2 linked publications.
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 16 Jul 2009.