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Completed

NCT Number: NCT02821637

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

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.

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Key information

Conditions

Pediatric Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHRMSA

Mulhouse, 68100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eurofit Tests of Physical Fitness (Eurofit)

Other

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.

Child Health Questionnaire (CHQ)

Behavioral

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.

Effort rehabilitation program

Other

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 outcomes

  1. 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 outcomes

  1. 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

  2. Aerobic and physical capacities assessed with the Eurofit tests results

    Time frame: Through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Other

Registry information

Official study 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

Acronym: PRESEVAL

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 1, 2016
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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