Lille Study for Childhood Health Promotion

NCT05121090 | Active Not Recruiting

• 2 other identifiers: 2020_432020-A02217-32
• Study Type: observational
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight, Infant; Overweight and Obesity; Overweight, Childhood

Keywords

Paediatric overweight and obesity; Childhood obesity; Personalized prevention and medicine; Educational program; Genetic of obesity

Outcome Measures

Primary Outcomes (1)

• Changes in BMI Z-score

  The objective is to estimate the mean variation of the BMI Z-score between the inclusion and the end of the educational program, after 2 years. Body mass index z score is based on previous results, estimate that the BMI Z-score will be decreased by 0.3 +/- 0.6 SD.

  At the end of the educational program, an average of 2 years after inclusion

Secondary Outcomes (5)

• BMI Z-score between children included in the study and a historical control group

  At the end of the educational program, an average of 2 years after inclusion

• Changes in BMI Z-score.

  At the end of the educational program follow-up, an average of 3 years after inclusion

• Correlation between clinical and environmental variables and changes in BMI Z-score

  At the end of the educational program, an average of 2 years after inclusion

• Impact of polygenic risk scores of obesity on changes in BMI Z-score

  Through study completion, an average of 3 years after inclusion

• Impact of rare pathogenic mutations causing obesity on changes in BMI Z-score.

  Through study completion, an average of 3 years after inclusion

Interventions

Educational program BEHAVIORAL

The educational program is based on dietary, physical activity, psychology, and sophrology approaches dispensed by health care professionals. Evaluations will consist of anthropometric measurements (height, weight, body mass index), behavioural questionnaires, and basic physical tests (handgrip, squats, balance, …). Optionally, a saliva collection will be proposed to obtain the DNA required for genetic analyses.

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children from the first year of primary school in Lille City

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• National Center for Precision Diabetic Medicine,PreciDIAB: collaborator
• PrevSanté MEL: collaborator
• APESAL: collaborator
• National Research Agency, France: collaborator
• European Union: collaborator
• Hauts-de-France Regional Council: collaborator
• University of Lille Nord de France: collaborator
• Groupement des Hôpitaux de l'Institut Catholique de Lille: collaborator

Study Sites (1)

Association PrevSanté MEL

Lille, 59000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Pediatric Obesity; Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Louise Montagne, MD

  Lille Catholic University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: November 16, 2021
• Study Start: January 19, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

FR (1)