Children Behavior About NutritionNUTRI-STATNCT02890420
Nutritional Status Of Under-Six Children: Epidemiology Study (NUTRI-STAT)
An observational study of Children Behavior About Nutrition, run by Centre Hospitalier Régional Metz-Thionville.
Trial summary
This study permit to evaluate the characteristics of children in third year of preschool, during a year, in 16 schools in Thionville (north-eastern France) by the way of the annual medical visit.The aim of the study is to describe the nutritional status of children under-six years of age: underweight, overweight, and… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Children Behavior About Nutrition
- How many people
- 262 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jul 2015
- Phase
- Observational
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children in third year of preschool in one of the 16 schools in Thionville, Lorraine, FRANCE
Who may be able to join
- third year of preschool in Thionville
- information of the legal responsibles
Who cannot join
- opposition of the legal responsible for gathering data
About this study
This study permit to evaluate the characteristics of children in third year of preschool, during a year, in 16 schools in Thionville (north-eastern France) by the way of the annual medical visit.The aim of the study is to describe the nutritional status of children under-six years of age: underweight, overweight, and obesity considering the sex. .
Read the detailed description
For several decades the eating behavior has been changing. That note is obviously more true for children, with the arrival of new recipes, not really healthier for all. This study permit to evaluate the characteristics of children in third year of preschool, during a year, in 16 schools in Thionville (north-eastern France) by the way of the annual medical visit. The aim of the research is to estimate the healthy weight corresponding with a height considering the gender.
- Conditions
- Children Behavior About Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Female children | Female children in third year of preschool in Thionville (north-eastern France) | |
| Male children | Male children in third year of preschool in Thionville (north-eastern France) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index of children
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Behavior About NutritionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre CUNY, MD, Principal investigator, CHR Metz-Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890420
- Sponsor's protocol ID
- 2014-01Obs-CHRMT
- Acronym
- NUTRI-STAT
- Status last verified
- Aug 2016
- First submitted
- 29 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status Of Under-Six Children: Epidemiology Study (NUTRI-STAT)
- ClinicalTrials.gov ID
- NCT02890420
- Acronym / sponsor ID
- NUTRI-STAT / 2014-01Obs-CHRMT
- Conditions
- Children Behavior About Nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 7 Sep 2016 (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.
This study permit to evaluate the characteristics of children in third year of preschool, during a year, in 16 schools in Thionville (north-eastern France) by the way of the annual medical visit.The aim of the study is to describe the nutritional status of children under-six years of age: underweight, overweight, and obesity considering the sex. .
Detailed description
For several decades the eating behavior has been changing. That note is obviously more true for children, with the arrival of new recipes, not really healthier for all. This study permit to evaluate the characteristics of children in third year of preschool, during a year, in 16 schools in Thionville (north-eastern France) by the way of the annual medical visit. The aim of the research is to estimate the healthy weight corresponding with a height considering the gender.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female children | – | –Female children in third year of preschool in Thionville (north-eastern France) |
| Male children | – | –Male children in third year of preschool in Thionville (north-eastern France) |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children in third year of preschool in one of the 16 schools in Thionville, Lorraine, FRANCE
Key inclusion criteria (2 listed)
- third year of preschool in Thionville
- information of the legal responsibles
Key exclusion criteria (1 listed)
- opposition of the legal responsible for gathering data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body mass index of children
Time frame: 1 year
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 7 Sep 2016.
- Individual participant dataSharing planned: No
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.
Pierre CUNY, MD principal investigator
CHR Metz-Thionville
Questions about this trial
What is this clinical trial studying?
An observational study of Children Behavior About Nutrition, run by Centre Hospitalier Régional Metz-Thionville.
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 2 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 7 Sep 2016. 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?
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?
Body mass index of children (time frame: 1 year). 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 7 Sep 2016.