Overweight, InfantELIPSENCT05121090
Lille Study for Childhood Health Promotion
An observational study of Overweight, Infant and Overweight and Obesity, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Infant, Overweight and Obesity, Overweight, Childhood
- What is being tested?
- Educational program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 460 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2022to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children from the first year of primary school in Lille City
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Child Obesity: an Interventional Study of a Personalized Multidisciplinary Care Efficacy in Children of Primary School
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.
Read more
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.
- Being tested
- Educational program
- Keywords
- Paediatric overweight and obesity, Childhood obesity, Personalized prevention and medicine, Educational program, Genetic of obesity
- Medical subject headings
- Pediatric Obesity, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (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
Measured: At the end of the educational program, an average of 2 years after inclusion
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 follow-up, 3 years after inclusion.
Measured: 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
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)
Measured: 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
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
Measured: Through study completion, an average of 3 years after inclusion
Impact of rare pathogenic mutations causing obesity on changes in BMI Z-score.
A whole-exome sequencing will be performed, followed by the identification of rare mutations involved in obesity or novel genes
Measured: Through study completion, an average of 3 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start19 Jan 2022
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight, InfantStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Precision Diabetic Medicine,PreciDIAB, PrevSanté MEL, APESAL, National Research Agency, France, European Union, Hauts-de-France Regional Council, University of Lille Nord de France, Groupement des Hôpitaux de l'Institut Catholique de Lille
- Responsible party
- Sponsor
- Investigators
- Louise Montagne, MD, Principal investigator, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121090
- Sponsor's protocol ID
- 2020_43
- Other IDs
- 2020-A02217-32
- Acronym
- ELIPSE
- Status last verified
- Apr 2026
- First submitted
- 23 Sep 2021
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Child Obesity: an Interventional Study of a Personalized Multidisciplinary Care Efficacy in Children of Primary School
- ClinicalTrials.gov ID
- NCT05121090
- Acronym / sponsor ID
- ELIPSE / 2020_43
- Keywords
- Paediatric overweight and obesity, Childhood obesity, Personalized prevention and medicine, Educational program, Genetic of obesity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- National Center for Precision Diabetic Medicine,PreciDIAB, PrevSanté MEL, APESAL, National Research Agency, France, European Union, Hauts-de-France Regional Council, University of Lille Nord de France, Groupement des Hôpitaux de l'Institut Catholique de Lille
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children from the first year of primary school in Lille City
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational programThe 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. | Behavioural | – |
Primary outcome
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.
5 secondary outcomes
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
Changes in BMI Z-score.
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 3 years after inclusion
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Montagne, MD principal investigator
Lille Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight, Infant and Overweight and Obesity, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in BMI Z-score (time frame: At the end of the educational program, an average of 2 years after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.