NCT02821637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2017

Completed
Last Updated

November 20, 2025

Status Verified

July 1, 2017

Enrollment Period

2.4 years

First QC Date

June 20, 2016

Last Update Submit

November 17, 2025

Conditions

Keywords

teenseffort rehabilitationquality of lifewellbeingphysical skills assessment

Outcome Measures

Primary Outcomes (1)

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

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • 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

  • Aerobic and physical capacities assessed with the Eurofit tests results

    Through study completion, an average of 1 year

Study Arms (1)

Effort rehabilitation program

OTHER

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)Behavioral: Child Health Questionnaire (CHQ)Other: Effort rehabilitation program

Interventions

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.

Effort rehabilitation program

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

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.

Effort rehabilitation program

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • BMI \> 97 percentile
  • at least one of the following symptoms :
  • respiratory functional signs
  • orthopedic complications
  • sleep apnea
  • cardiovascular complications
  • metabolic syndrome

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GHRMSA

Mulhouse, 68100, France

Location

Related Links

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

July 1, 2016

Study Start

January 14, 2015

Primary Completion

May 22, 2017

Study Completion

May 22, 2017

Last Updated

November 20, 2025

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations