Overweight, ChildhoodLTRNCT04360083
Long-term Assessment of Rhône RéPPOP Care for Overweight and Obese Children.
An observational study of Overweight, Childhood and Pediatric Obesity, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Childhood obesity is a major public health issue since it is a risk factor of adulthood obesity, cardiovascular disease, psychological disorders, and other chronic conditions. RéPPOP is a two year personalized pathway for multidisciplinary care for overweight and obese children, close to patients' homes. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Overweight, Childhood, Pediatric Obesity
- What is being tested?
- Collected data from Rhône RéPPOP database and telephonic questionnaire
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2021to 7 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Overweight and obese children included in RéPPOP care programs between 2007 and 2010
Who may be able to join
- All overweight and obese children included in RéPPOP care programs from 01/01/07 to 31/12/10
Who cannot join
- Refusal to respond to the telephonic questionnaire
- Subjects who withdraw their consent to participate in the study
- Subjects aged under 12 years
Trial locations and contacts
1 site in 1 country.
About this study
Childhood obesity is a major public health issue since it is a risk factor of adulthood obesity, cardiovascular disease, psychological disorders, and other chronic conditions.
RéPPOP is a two year personalized pathway for multidisciplinary care for overweight and obese children, close to patients' homes.
Read more
Short and medium-term assessments of Rhône RéPPOP care for overweight and obese children show encouraging results. Long-term assessment is needed to confirm these results.
The present study aims to assess the long-term efficiency of Rhône RéPPOP care for overweight and obese children by comparing BMI Z-scores at the start and the end of RéPPOP care to the current BMI. This data will be collected through a telephonic questionnaire by the scientific manager.
The study's secondary objectives are to evaluate patients and their families' lifestyle changes and to improve RéPPOP practices.
- Conditions
- Overweight, Childhood, Pediatric Obesity
- Being tested
- Collected data from Rhône RéPPOP database, telephonic questionnaire
- Keywords
- Pediatric Obesity, Overweight, Childhood
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collected data from Rhône RéPPOP databaseOther
BMI Z-scores at the start and the end of RéPPOP care programs.
telephonic questionnaireOther
Collected data though the telephonic questionnaire : current declared BMI Z-score.
| Study group | Role | What they receive |
|---|---|---|
| Overweight and obese children | Overweight and obese children included in RéPPOP care programs between 2007 and 2010. Receives: Other: Collected data from Rhône RéPPOP database; Other: telephonic questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of BMI Z-scores at the start and the end of RéPPOP care programs to the current BMI Z score.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start15 Feb 2021
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight, ChildhoodStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc NICOLINO, MD, Principal investigator, Hospices Civils de Lyon, Endocrino-pediatric service, HFME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360083
- Sponsor's protocol ID
- 69HCL19_0285
- Other IDs
- 2020-A00787-32
- Acronym
- LTR
- Status last verified
- Mar 2023
- First submitted
- 22 Apr 2020
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Assessment of Rhône RéPPOP Care for Overweight and Obese Children.
- ClinicalTrials.gov ID
- NCT04360083
- Acronym / sponsor ID
- LTR / 69HCL19_0285
- Conditions
- Overweight, Childhood, Pediatric Obesity
- Keywords
- Pediatric Obesity, Overweight, Childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 24 Apr 2020 (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.
Childhood obesity is a major public health issue since it is a risk factor of adulthood obesity, cardiovascular disease, psychological disorders, and other chronic conditions.
RéPPOP is a two year personalized pathway for multidisciplinary care for overweight and obese children, close to patients' homes.
Short and medium-term assessments of Rhône RéPPOP care for overweight and obese children show encouraging results. Long-term assessment is needed to confirm these results.
The present study aims to assess the long-term efficiency of Rhône RéPPOP care for overweight and obese children by comparing BMI Z-scores at the start and the end of RéPPOP care to the current BMI. This data will be collected through a telephonic questionnaire by the scientific manager.
The study's secondary objectives are to evaluate patients and their families' lifestyle changes and to improve RéPPOP practices.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overweight and obese children | – | Other: Collected data from Rhône RéPPOP database, Other: telephonic questionnaireOverweight and obese children included in RéPPOP care programs between 2007 and 2010. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Overweight and obese children included in RéPPOP care programs between 2007 and 2010
Key inclusion criteria (1 listed)
- All overweight and obese children included in RéPPOP care programs from 01/01/07 to 31/12/10
Key exclusion criteria (3 listed)
- Refusal to respond to the telephonic questionnaire
- Subjects who withdraw their consent to participate in the study
- Subjects aged under 12 years
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 |
|---|---|---|
| Collected data from Rhône RéPPOP databaseBMI Z-scores at the start and the end of RéPPOP care programs. | Other | Overweight and obese children |
| telephonic questionnaireCollected data though the telephonic questionnaire : current declared BMI Z-score. | Other | Overweight and obese children |
Primary outcome
Comparison of BMI Z-scores at the start and the end of RéPPOP care programs to the current BMI Z score.
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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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.
Marc NICOLINO, MD principal investigator
Hospices Civils de Lyon, Endocrino-pediatric service, HFME
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, Childhood and Pediatric Obesity, run by Hospices Civils de Lyon 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 9 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of BMI Z-scores at the start and the end of RéPPOP care programs to the current BMI Z score. (time frame: Day 0). 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 9 Mar 2023.