Clinical trial NCT05121090: Lille Study for Childhood Health Promotion
Official title: Prevention of Child Obesity: an Interventional Study of a Personalized Multidisciplinary Care Efficacy in Children of Primary School
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Overweight, Infant
Overweight and Obesity
Overweight, Childhood
Keywords: Paediatric overweight and obesity
Childhood obesity
Personalized prevention and medicine
Educational program
Genetic of obesity
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: National Center for Precision Diabetic Medicine,PreciDIAB
name: PrevSanté MEL
name: APESAL
name: National Research Agency, France
name: European Union
name: Hauts-de-France Regional Council
name: University of Lille Nord de France
name: Groupement des Hôpitaux de l'Institut Catholique de Lille
First posted: 2021-11-16
Enrollment: 460
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children from the first year of primary school in Lille City

Brief summary: Obesity could be avoided but once declared it become a chronic disease with numerous health complications, including cardiovascular and metabolic diseases, cancers, and finally a loss of life expectancy. Considering that after the age of 6 years old, half of the obese children will become obese adults, the WHO has been declared childhood obesity prevention as a health priority area. Large-scale prevention of obesity is challenging and it would be more efficient to proceed to early identification of high risks children to implement personalized prevention.

The ELIPSE study main objective is to evaluate the efficacy of personalized multidisciplinary care to reduce the BMI of overweight or obese children. A 2 years educational program will be evaluated at short and longer terms (after a 12 months follow-up), and its benefits will also be assessed based on comparison with a historical control group.

Along with efficacy evaluation, scientific objectives were designed to investigate clinical, genetic, social, and behavioural risk factors and to analyse potential correlations between these factors and a predisposition to overweight or obesity. Moreover, advanced analyses will be performed to decipher the impact of diverse risk profiles on the efficacy of the educational program.

The motive of the ELIPSE study is to promote the health and well-being of children and their families to tackle the health burden represented by childhood overweight and obesity. Combined with innovative scientific objectives, this study ambitions to develop more efficient and more personalized preventive care methods.


Eligibility criteria: Inclusion Criteria:

* Children from the first year of primary school in Lille City
* Overweight or obese children as defined by the IOTF and/or with at least one of the following risk factors: 1) early adiposity rebound (before 6 years old), 2) an upward crossing of major percentiles on the BMI curve (after 6 years old).
* Children whose legal tutor(s) is(are) able to understand the enlightened information.
* Children whose legal tutor(s) has(ve) signed the free and informed consent.

Exclusion Criteria:

* Refusal from children or their tutors to participate in the study.
* Impossibility to participate in the study in its totality.
* Pathology known to impact the BMI: follow-up care for eating behaviour problems, endocrine disorders (hypercorticism, hypothyroidism, growth factor deficiency, hypothalamic-hypophysis lesions), genetic disorders (Prader Willi syndrome, Bardet-Biedl syndrome), drugs that affect body weight (antidepressant, neuroleptics, corticoids).
* Previous participation in a similar educational program.

Primary outcomes:
measure: Changes in BMI Z-score
timeFrame: At the end of the educational program, an average of 2 years after inclusion
Secondary outcomes:
measure: BMI Z-score between children included in the study and a historical control group
timeFrame: At the end of the educational program, an average of 2 years after inclusion
measure: Changes in BMI Z-score.
timeFrame: At the end of the educational program follow-up, an average of 3 years after inclusion
measure: Correlation between clinical and environmental variables and changes in BMI Z-score
timeFrame: At the end of the educational program, an average of 2 years after inclusion
measure: Impact of polygenic risk scores of obesity on changes in BMI Z-score
timeFrame: Through study completion, an average of 3 years after inclusion
measure: Impact of rare pathogenic mutations causing obesity on changes in BMI Z-score.
timeFrame: Through study completion, an average of 3 years after inclusion
Other outcomes:
Locations:
Study officials:
affiliation: Lille Catholic University
name: Louise Montagne, MD
role: PRINCIPAL_INVESTIGATOR
References: