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

Pediatric Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821637
• Other study ID #: 754
• Secondary ID: 2014-A01695-42
• Status: Completed
• Phase: N/A
• Start date: January 14, 2015
• Est. completion date: May 22, 2017

Study information

• Verified date: July 2017
• Source: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 22, 2017
• Est. primary completion date: May 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Pediatric Obesity

Intervention

Other:
• Eurofit Tests of Physical Fitness (Eurofit)
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.

Behavioral:
• Child Health Questionnaire (CHQ)
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.

Other:
• Effort rehabilitation program
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.

Locations

Country	Name	City	State
France	GHRMSA	Mulhouse

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

References & Publications (2)

Bar-or O. Médecine du Sport chez l'enfant. Principes physiologiques et applications cliniques. Paris : Masson ; 1987

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution in the score of the Child Health Questionnaire (CHQ) of quality of life		Through study completion, an average of 1 year
Secondary	Appetency to physical activity assessed with the evolution of the amount of time spent weekly in a physical activity		Through study completion, an average of 1 year
Secondary	Aerobic and physical capacities assessed with the Eurofit tests results		Through study completion, an average of 1 year

External Links

•   English version - Recommendations on the eurofit tests of physical fitness
•   English version of the National Health Authority (French acronym : HAS) listing recommendations for overweight or obese children
•   French article about obesity, type 2 diabetes and Adapted Physical Activity
•   French Obesity Plan 2010-2013
•   Publication from Department of Movement and Sports Sciences, Ghent University, BELGIUM about physical activity for babies and toddlers