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Active, Not Recruiting

NCT Number: NCT05121090

Lille Study for Childhood Health Promotion

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Overweight, Infant Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Overweight, Childhood Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Association PrevSanté MEL

Lille, 59000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Changes in BMI Z-score

    Time frame: At 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.

Secondary outcomes

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

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

    At the end of the educational program (2 years after inclusion), BMI Z-scores of children who completed the study will be compared to those of a historical control group composed of children of similar ages who did not benefit from an educational program

  2. Changes in BMI Z-score.

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

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

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

    The objective is to study the statistical relationship between the BMI Z-score and clinical and environmental variables: birth weight (kg), mother's BMI (kg/m^2), gestationnel diabetes, parental weight loss surgery, number of child(ren) in the family, socioeconomic status evaluated by the parents socio-professional category (french indices), smoking during pregrancy)

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

    Time frame: Through study completion, an average of 3 years after inclusion

    A multi-variants analysis will be performed using DNA chips to identify loci associated with an increase of the BMI to obtained a polygenic risk score. This score will then be included as a variable for the analyses of the secondary outcome

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

    Time frame: Through study completion, an average of 3 years after inclusion

    A whole-exome sequencing will be performed, followed by the identification of rare mutations involved in obesity or novel genes

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

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

Registry information

Official study title

Prevention of Child Obesity: an Interventional Study of a Personalized Multidisciplinary Care Efficacy in Children of Primary School

Acronym: ELIPSE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Nov 16, 2021
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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