NCT03342092

Brief Summary

This study aims to assess different methods for early adiposity rebound determination at the age of 4/5 years old according to current medical screening criteria in schools, and to assess their prognostic value for obesity amongst 11 years old pre-adolescents according to the known risk factors.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
868

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

3.2 years

First QC Date

November 7, 2017

Last Update Submit

November 9, 2017

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

  • Body mass index of 11 years old pre-adolescents

    Composite outcome based on height and weight

    month 22

Study Arms (1)

Questionnaire

Questionnaires distributed to the families 15 days before child's medical consultation

Other: Questionnaire

Interventions

QuestionnaireOTHER

Questionnaires distributed to the families 15 days before child's medical consultation + anthropometric measures and data collected from the personal interview with school nurse

Questionnaire

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children initially enrolled in two successive surveys of build evolution and overweight determinants among a children cohort (both surveys representing the first time of the cohort), conducted in 2008.

You may qualify if:

  • Boys and girls born between 1st July 2003 and 30th June 2004
  • Attending school in Haute-Saône
  • Enrolled in the 2008 cohort survey

You may not qualify if:

  • Children whose parents refused to take part in this cohort study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Stéphanie Pasteur, MD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2017

First Posted

November 14, 2017

Study Start

September 24, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)