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Impact of an Effort Rehabilitation Program for Overweight/Obese Children/Teens on Quality of Life and Wellbeing (PRESEVAL)

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Eurofit Tests of Physical Fitness (Eurofit)
Child Health Questionnaire (CHQ)
Effort rehabilitation program
Sponsored by
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pediatric Obesity focused on measuring teens, effort rehabilitation, quality of life, wellbeing, physical skills assessment

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI > 97 percentile
  • at least one of the following symptoms :

    • respiratory functional signs
    • orthopedic complications
    • sleep apnea
    • cardiovascular complications
    • metabolic syndrome

Exclusion Criteria:

  • lack of motivation
  • uncontrolled psychological issue
  • ambulatory care more appropriate to treat the same issues
  • any related psychiatric pathology likely to worsen with weight loss
  • patient or family not committed to therapeutics program
  • psychological inability to deal with separation
  • behavior disorders making collective activity impossible

Sites / Locations

  • GHRMSA

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Effort rehabilitation program

Arm Description

An effort rehabilitation program designed for obese and overweight children or teens : 13 weekly sessions of 1hour30 then 1 session 2 months, 6 months and 12 months later. This program is part of the routine practice of the Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse. Child Health Questionnaire (CHQ) of quality of life are completed by parents and children on the 1st and the 13th session, then 3 more times : 2, 6 and 12 months after the 13th session. Eurofit tests of Physical Fitness performed on the 1st and the 13th session, then 3 more times : 2, 6 and 12 months after the 13th session.

Outcomes

Primary Outcome Measures

Evolution in the score of the Child Health Questionnaire (CHQ) of quality of life

Secondary Outcome Measures

Appetency to physical activity assessed with the evolution of the amount of time spent weekly in a physical activity
Aerobic and physical capacities assessed with the Eurofit tests results

Full Information

First Posted
June 20, 2016
Last Updated
August 20, 2019
Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
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1. Study Identification

Unique Protocol Identification Number
NCT02821637
Brief Title
Impact of an Effort Rehabilitation Program for Overweight/Obese Children/Teens on Quality of Life and Wellbeing
Acronym
PRESEVAL
Official Title
Impact of an Effort Rehabilitation Program for Overweight or Obese Children and Teens on Quality of Life and Wellbeing: A French Monocentric Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 14, 2015 (Actual)
Primary Completion Date
May 22, 2017 (Actual)
Study Completion Date
May 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Obese and overweight children or teens can join the Prevention and Care of Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse. Those patients who are no longer able to exercize because of their physical condition start an effort rehabilitation program at the Organization. The study will evaluate the impact of this rehabilitation program on quality of life and appetency to physical activity for these children and teens.
Detailed Description
Because of a National Obesity Plan (2010-2013) initiated by the French government in charge of health, the Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse was created in 2011. This Organization is in charge of children or teens with: severe or growing obesity associated with respiratory, osteo-articular metabolic complications comorbidities worsened by obesity The Organization and the Physical Medicine and Rehabilitation department of the Mulhouse Hospital have worked together to create an effort rehabilitation program for obese or overweight children. The program, aiming movement rehabilitation, is based on reinforcement and endurance activities in a playful atmosphere and in an important motivational dimension. A medical examination is performed before the first session to confirm the patient's ability to follow an effort rehabilitation program. Each session is supervised by a teacher of adapted physical activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
teens, effort rehabilitation, quality of life, wellbeing, physical skills assessment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effort rehabilitation program
Arm Type
Other
Arm Description
An effort rehabilitation program designed for obese and overweight children or teens : 13 weekly sessions of 1hour30 then 1 session 2 months, 6 months and 12 months later. This program is part of the routine practice of the Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse. Child Health Questionnaire (CHQ) of quality of life are completed by parents and children on the 1st and the 13th session, then 3 more times : 2, 6 and 12 months after the 13th session. Eurofit tests of Physical Fitness performed on the 1st and the 13th session, then 3 more times : 2, 6 and 12 months after the 13th session.
Intervention Type
Other
Intervention Name(s)
Eurofit Tests of Physical Fitness (Eurofit)
Intervention Description
Eurofit tests are a physical skills assessment. For the study, tests performed on the 1st and the 13th session of the program, then 3 more times : 2 months, 6 months and 12 months after the 13th weekly session.
Intervention Type
Behavioral
Intervention Name(s)
Child Health Questionnaire (CHQ)
Intervention Description
The CHQ is a questionnaire about quality of life. The CHQ children form (CHQ-CF87) and the CHQ parent form (CHQ-PF50) are completed each time the Eurofit tests are performed : at the 1st and 13th weekly session then 2 months, 6 months and 12 months later.
Intervention Type
Other
Intervention Name(s)
Effort rehabilitation program
Intervention Description
Part of the routine practice of the Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse, the program consists in 13 sessions of 1hour30 of adapted physical activity. The physical activity in this program use cycles of games where rules are adapted to the overweight or obese children. The activities are performed in a playful atmosphere, for example using creative games like tchoukball or peteca, with each session aiming a specific objective each time.
Primary Outcome Measure Information:
Title
Evolution in the score of the Child Health Questionnaire (CHQ) of quality of life
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Appetency to physical activity assessed with the evolution of the amount of time spent weekly in a physical activity
Time Frame
Through study completion, an average of 1 year
Title
Aerobic and physical capacities assessed with the Eurofit tests results
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI > 97 percentile at least one of the following symptoms : respiratory functional signs orthopedic complications sleep apnea cardiovascular complications metabolic syndrome Exclusion Criteria: lack of motivation uncontrolled psychological issue ambulatory care more appropriate to treat the same issues any related psychiatric pathology likely to worsen with weight loss patient or family not committed to therapeutics program psychological inability to deal with separation behavior disorders making collective activity impossible
Facility Information:
Facility Name
GHRMSA
City
Mulhouse
ZIP/Postal Code
68100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15294008
Citation
Fulton JE, Garg M, Galuska DA, Rattay KT, Caspersen CJ. Public health and clinical recommendations for physical activity and physical fitness: special focus on overweight youth. Sports Med. 2004;34(9):581-99. doi: 10.2165/00007256-200434090-00003.
Results Reference
background
Citation
Bar-or O. Médecine du Sport chez l'enfant. Principes physiologiques et applications cliniques. Paris : Masson ; 1987
Results Reference
background
Links:
URL
http://www.enfant-encyclopedie.com/Pages/PDF/Cardon-van_Cauwenberghe-de_BourdeaudhuijFRxp1.pdf
Description
Publication from Department of Movement and Sports Sciences, Ghent University, BELGIUM about physical activity for babies and toddlers
URL
http://social-sante.gouv.fr/IMG/pdf/Plan_Obesite_2010_2013.pdf
Description
French Obesity Plan 2010-2013
URL
http://www.has-sante.fr/portail/upload/docs/application/pdf/2012-09/overweight_and_obesity_in_children_and_adolescents_-_quick_reference_guide.pdf
Description
English version of the National Health Authority (French acronym : HAS) listing recommendations for overweight or obese children
URL
http://link.springer.com/article/10.1007%2Fs11659-012-0303-6#page-1
Description
French article about obesity, type 2 diabetes and Adapted Physical Activity
URL
https://www.coe.int/t/dg4/epas/resources/texts/Rec(87)9_en.pdf
Description
English version - Recommendations on the eurofit tests of physical fitness

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Impact of an Effort Rehabilitation Program for Overweight/Obese Children/Teens on Quality of Life and Wellbeing

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