School Intervention Study of Nutrition, Wellbeing and Den... | NCT00530153

Studies
School Intervention Study of Nutrition, Wellbeing and Dental Health

NCT00530153

Sponsor

Finnish Institute for Health and Welfare

Status

Unknown status

Last Update Posted

Sep 30, 2009Estimated

Enrollment

769Actual

Phase

Not Applicable

Conditions

Eating
Oral Health

Interventions

dietary counseling
xylitol

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Not provided

Completion Date

May 2008Estimated

First Submitted Date

Sep 14, 2007

First Submission Date that Met QC Criteria

Sep 14, 2007

First Posted Date

Sep 17, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2009

Last Update Posted Date

Sep 30, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Finnish Institute for Health and WelfareOTHER_GOV

Collaborators

Name	Class
University of Oulu, Department of dental health	OTHER
Sitra, the Finnish Innovation Fund	OTHER

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

769Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dietary counseling	Behavioral	Various activities and materials for teachers, students, parents and school catering personnel aiming at increasing their awareness and knowledge of good nutrition.
xylitol	Dietary Supplement	Delivery of xylitol lozenges (about 1 g xylitol/student/school day) and guidance on tooth brushing.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dietary intake (eg. sugar, fibre). The presence of active initial caries lesions.

Secondary Outcomes

Measure	Description	Time Frame
Nutritional quality of school meals and snacks. Laser fluorescence values of the occlusal surfaces of permanent molar and premolar teeth.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

7th grade students from the participating schools, written informed consent both from the student and the parent

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pirjo Pietinen, Ph. D	National Public Health Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Public Health Institute		Helsinki		00300	Finland

Condition Browse Module

MeSH Terms

ID	Term
D005247	Feeding Behavior

Ancestor Terms

ID	Term
D001522	Behavior, Animal
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015596	Nutrition Assessment
D014993	Xylitol

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided