Pediatric ObesityPRESEVALNCT02821637
Impact of an Effort Rehabilitation Program for Overweight/Obese Children/Teens on Quality of Life and Wellbeing
A study testing Eurofit Tests of Physical Fitness (Eurofit), Child Health Questionnaire (CHQ) and Effort rehabilitation program in people with Pediatric Obesity, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Eurofit Tests of Physical Fitness (Eurofit), Child Health Questionnaire (CHQ) and Effort rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2015to 22 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI > 97 percentile
- at least one of the following symptoms :
- respiratory functional signs
- orthopedic complications
- sleep apnea
- cardiovascular complications
- metabolic syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pediatric Obesity
- Being tested
- Eurofit Tests of Physical Fitness (Eurofit), Child Health Questionnaire (CHQ), Effort rehabilitation program
- Keywords
- teens, effort rehabilitation, quality of life, wellbeing, physical skills assessment
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Behavioural
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Eurofit Tests of Physical Fitness (Eurofit); Behavioral: Child Health Questionnaire (CHQ); Other: Effort rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution in the score of the Child Health Questionnaire (CHQ) of quality of life
Measured: 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
Measured: Through study completion, an average of 1 year
Aerobic and physical capacities assessed with the Eurofit tests results
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start14 Jan 2015
- Primary completion22 May 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821637
- Sponsor's protocol ID
- GHRMSA 754
- Other IDs
- 2014-A01695-42
- Acronym
- PRESEVAL
- Status last verified
- Jul 2017
- First submitted
- 20 Jun 2016
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02821637
- Acronym / sponsor ID
- PRESEVAL / GHRMSA 754
- Conditions
- Pediatric Obesity
- Keywords
- teens, effort rehabilitation, quality of life, wellbeing, physical skills assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 14 Jan 2015 (actual)
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effort rehabilitation program | Other | Other: Eurofit Tests of Physical Fitness (Eurofit), Behavioral: Child Health Questionnaire (CHQ), Other: Effort rehabilitation programAn 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. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- BMI > 97 percentile
- at least one of the following symptoms :
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Effort rehabilitation program |
| 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. | Behavioural | Effort rehabilitation program |
| Effort rehabilitation programPart 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. | Other | Effort rehabilitation program |
Primary outcome
Evolution in the score of the Child Health Questionnaire (CHQ) of quality of life
Time frame: Through study completion, an average of 1 year
2 secondary outcomes
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
Aerobic and physical capacities assessed with the Eurofit tests results
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eurofit Tests of Physical Fitness (Eurofit), Child Health Questionnaire (CHQ) and Effort rehabilitation program in people with Pediatric Obesity, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution in the score of the Child Health Questionnaire (CHQ) of quality of life (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.