Lille Study for Childhood Health Promotion

NCT ID: NCT05121090

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 460 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2026-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Educational program

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Precision Diabetic Medicine,PreciDIAB

UNKNOWN

Sponsor Role: collaborator

PrevSanté MEL

UNKNOWN

Sponsor Role: collaborator

APESAL

UNKNOWN

Sponsor Role: collaborator

National Research Agency, France

OTHER

Sponsor Role: collaborator

European Union

OTHER

Sponsor Role: collaborator

Hauts-de-France Regional Council

UNKNOWN

Sponsor Role: collaborator

University of Lille Nord de France

OTHER

Sponsor Role: collaborator

Groupement des Hôpitaux de l'Institut Catholique de Lille

UNKNOWN

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louise Montagne, MD

Role: PRINCIPAL_INVESTIGATOR

Lille Catholic University

Central Contacts

Matthias Vandesquille, PhD

Role: CONTACT

matthias.vandesquille@univ-lille.fr

03 20 97 42 56 ext. +33

Louise Montagne, MD

Role: CONTACT

elipse@precidiab.org

Other Identifiers

2020-A02217-32

Identifier Type: OTHER

Identifier Source: secondary_id

2020_43

Identifier Type: -

Identifier Source: org_study_id