Long-term Assessment of Rhône RéPPOP Care for Overweight... | NCT04360083

Studies
Long-term Assessment of Rhône RéPPOP Care for Overweight and Obese Children.

NCT04360083

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Mar 9, 2023Actual

Enrollment

106Actual

Phase

Not provided

Conditions

Overweight, Childhood
Pediatric Obesity

Interventions

Collected data from Rhône RéPPOP database
telephonic questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A00787-32	Other Identifier	ID-RCB

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2021Actual

Primary Completion Date

Dec 7, 2021Actual

Completion Date

Dec 7, 2021Actual

First Submitted Date

Apr 22, 2020

First Submission Date that Met QC Criteria

Apr 22, 2020

First Posted Date

Apr 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2023

Last Update Posted Date

Mar 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Overweight and obese children		Overweight and obese children included in RéPPOP care programs between 2007 and 2010.	Other: Collected data from Rhône RéPPOP database Other: telephonic questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collected data from Rhône RéPPOP database	Other	BMI Z-scores at the start and the end of RéPPOP care programs.	Overweight and obese children

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of BMI Z-scores at the start and the end of RéPPOP care programs to the current BMI Z score.		Day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- All overweight and obese children included in RéPPOP care programs from 01/01/07 to 31/12/10

Exclusion Criteria:

Refusal to respond to the telephonic questionnaire
Subjects who withdraw their consent to participate in the study
Subjects aged under 12 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Overweight and obese children included in RéPPOP care programs between 2007 and 2010

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc NICOLINO, MD	Hospices Civils de Lyon, Endocrino-pediatric service, HFME	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospices civils de Lyon, Endocrino-pediatric service		Bron		69500	France

Condition Browse Module

MeSH Terms

ID	Term
D063766	Pediatric Obesity

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided