Clinical trial

Lille Study for Childhood Health Promotion

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05121090

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age5 Years to 6 Years

SexAll

Healthy volunteersAccepted

ConditionOverweight, Infant, Overweight and Obesity, Overweight, Childhood

Full registry 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.

Treatments and study arms

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.

Primary outcomes

Changes in BMI Z-scoreAt the end of the educational program, an average of 2 years after inclusion

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Association PrevSanté MEL🇫🇷 Lille, France

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