EatingNCT00530153
School Intervention Study of Nutrition, Wellbeing and Dental Health
A study testing dietary counseling and xylitol in people with Eating and Oral Health, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
The purpose of this study is to evaluate the effects of an intervention programme on dietary intake and dental health of 8th grade students. Read more about this study
- Who is it for?
- Ages 13 to 14 years
- Conditions the study is for
- Eating, Oral Health
- What is being tested?
- dietary counseling and xylitol
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 769 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2007to May 2008
- 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 13 to 14 years
- All sexes
- Child
Who may be able to join
- 7th grade students from the participating schools, written informed consent both from the student and the parent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effects of an intervention programme on dietary intake and dental health of 8th grade students.
- Conditions
- Eating, Oral Health
- Being tested
- dietary counseling, xylitol
- Keywords
- Eating, Food Habits, Adolescent, Dental Research
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary counselingBehavioural
Various activities and materials for teachers, students, parents and school catering personnel aiming at increasing their awareness and knowledge of good nutrition.
xylitolDietary supplement
Delivery of xylitol lozenges (about 1 g xylitol/student/school day) and guidance on tooth brushing.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary intake (eg. sugar, fibre). The presence of active initial caries lesions.
Secondary outcomes (1)
Nutritional quality of school meals and snacks. Laser fluorescence values of the occlusal surfaces of permanent molar and premolar teeth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startApr 2007
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EatingStudies 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
- 769 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- University of Oulu, Department of dental health, Sitra, the Finnish Innovation Fund
- Investigators
- Pirjo Pietinen, Ph. D, Principal investigator, National Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530153
- Sponsor's protocol ID
- KTL 369-3
- Status last verified
- Sep 2009
- First submitted
- 14 Sep 2007
- Last updated
- 30 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Intervention Study of Nutrition, Wellbeing and Dental Health
- ClinicalTrials.gov ID
- NCT00530153
- Acronym / sponsor ID
- KTL 369-3
- Conditions
- Eating, Oral Health
- Keywords
- Eating, Food Habits, Adolescent, Dental Research
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 769 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- University of Oulu, Department of dental health, Sitra, the Finnish Innovation Fund
- Study start
- Apr 2007
- Study completion
- May 2008 (estimated)
- First posted
- 17 Sep 2007 (estimated)
- 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 study is to evaluate the effects of an intervention programme on dietary intake and dental health of 8th grade students.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 13 to 14 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- 7th grade students from the participating schools, written informed consent both from the student and the parent
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 |
|---|---|---|
| dietary counselingVarious activities and materials for teachers, students, parents and school catering personnel aiming at increasing their awareness and knowledge of good nutrition. | Behavioural | – |
| xylitolDelivery of xylitol lozenges (about 1 g xylitol/student/school day) and guidance on tooth brushing. | Dietary supplement | – |
Primary outcome
Dietary intake (eg. sugar, fibre). The presence of active initial caries lesions.
1 secondary outcome
Nutritional quality of school meals and snacks. Laser fluorescence values of the occlusal surfaces of permanent molar and premolar teeth.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2009.
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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.
Pirjo Pietinen, Ph. D principal investigator
National Public Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary counseling and xylitol in people with Eating and Oral Health, run by Finnish Institute for Health and Welfare at 1 site in Finland.
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 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: status not confirmed, as of the sponsor's last update on 30 Sep 2009. 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 Finland. 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?
Results are not available in the source record.
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?
Dietary intake (eg. sugar, fibre). The presence of active initial caries lesions.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2009.