Clinical trial NCT02821637: Impact of an Effort Rehabilitation Program for Overweight/Obese Children/Teens on Quality of Life and Wellbeing
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
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: teens
effort rehabilitation
quality of life
wellbeing
physical skills assessment
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 47
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Evolution in the score of the Child Health Questionnaire (CHQ) of quality of life
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Appetency to physical activity assessed with the evolution of the amount of time spent weekly in a physical activity
timeFrame: Through study completion, an average of 1 year
measure: Aerobic and physical capacities assessed with the Eurofit tests results
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: GHRMSA
Study officials:
References:
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.
citation: Bar-or O. Médecine du Sport chez l'enfant. Principes physiologiques et applications cliniques. Paris : Masson ; 1987