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

August 20, 2019 updated by: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Impact of an Effort Rehabilitation Program for Overweight or Obese Children and Teens on Quality of Life and Wellbeing: A French Monocentric Prospective Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Mulhouse, France, 68100
        • GHRMSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Effort rehabilitation program

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evolution in the score of the Child Health Questionnaire (CHQ) of quality of life
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Through study completion, an average of 1 year
Aerobic and physical capacities assessed with the Eurofit tests results
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2015

Primary Completion (Actual)

May 22, 2017

Study Completion (Actual)

May 22, 2017

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 754
  • 2014-A01695-42 (Other Identifier: France: Agence Nationale de Sécurité du Médicament et des produits de santé)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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