ObesityQOL-ADOBNCT02417909
Overweight, Quality of Life and Psychological Difficulties in Teenagers
An observational study of Obesity, run by Lille Catholic University.
Trial summary
Obesity is a major public heath issue. It may have various impacts on a patient's life by causing psychological problems, altering a patient's quality of life,etc. These led to the investigators' hypothesis which is examining the psychological dimensions of a teenager suffering for obesity. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- questionnaires about quality of life
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Jul 2015
- Phase
- Observational
- 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 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Two categories of teenagers will be included : obese teenagers and average weighted volonteers
Who may be able to join
- Patients aged between 11 and 16 years old at the moment of enrollment.
- Body Mass Index between the 1st and 2nd degree of the obesity zone (over the 97th percentile curve regarding corpulence curves of the Plan National Nutrition Santé (PNNS) based on the gender (boys/girls))
- The teenagers have an appointment in the pediatric unit of the Saint Vincent de Paul Hospital for an examination regarding excess weight
- Patients aged between 11 and 16 years old at the moment of enrollment
- Body Mass Index located between the 3rd and the 97th percentile on the corpulence curves of the PNNS
- The teenagers and their parents have replied to and advertisement of the trial
Who cannot join
- Body Mass Index over the 97th percentile curve on the corpulence curves of the PNNS
- Handicapped teenagers
- Body Mass Index over the 97th percentile curve or under the 3rd percentile curve on the corpulence curves of the PNNS
- Handicapped, asthmatic, obese or diabetic teenagers
About this study
Official title: Quality of Life and Psychological Difficulties in Relation With the Weight of Teenagers
Obesity is a major public heath issue. It may have various impacts on a patient's life by causing psychological problems, altering a patient's quality of life,etc. These led to the investigators' hypothesis which is examining the psychological dimensions of a teenager suffering for obesity.
Read the detailed description
There are two groups in this study : healthy volunteers and teenagers suffering from obesity.
Patients and healthy volunteers will come to the nutrition clinic center Naturalpha where the patient will complete a questionnaire. The included patients will also complete a questionnaire privately (without the presence of the parents), they will also be weighted and measured.
No further tests or questionnaires will be given after the enrollment day.
- Conditions
- Obesity
- Being tested
- questionnaires about quality of life
- Keywords
- Obesity, quality of life, teenagers, psychological impact
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires about quality of lifeOther
all teenagers included in the trial and their parents must complete the questionnaires given of them the day of enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | This group is composed of healthy teenagers that volunteered to participate in the trial and that will answer questionnaires about quality of life. Parents will anwser questionnaires too. Receives: Other: questionnaires about quality of life | |
| Obese teenagers | This group is composed of obese teenagers that have been recruited to participate in the trial and that will answer different questionnaires quality of life. Parents will anwser questionnaires too. Receives: Other: questionnaires about quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the quality of life of obese and average weighted teenagers
patients are weighted, measured and are asked to complete quality of life questionnaires. The parents are also asked to complete a questionnaire.
The questionnaires answered by the teenagers are KIDSCREEN; CES-D; STAI-C; PJNA; EPADV; EPCDV and EQRI, they will be analysed along with the questionnaires completed by the parents, inorder to compare the quality of life of obese and average weighted teenagers.
Measured: day of enrollment
Secondary outcomes (5)
Compare psychopathologic symptoms (depression, anxiety and social anxiety) in both populations
Patients are asked to complete quality of life questionnaires. The parents are also asked to complete a questionnaire.
Measured: day of enrollement
Compare the satisfaction of the needs described in the theory of auto-determination in both populations
Patients are asked to complete quality of life questionnaires. The parents are also asked to complete a questionnaire.
Measured: day fo enrollment
Explore the link between endured stigmatisation and self esteem for obese teenagers
Patients are asked to complete quality of life questionnaires. The parents are also asked to complete a questionnaire.
Measured: day of enrollment
Explore the effect of the support of the needs described in the auto-determination theory and their link to endured stigmatisation, quality of life and self esteem, for obese teenagers.
Patients are asked to complete quality of life questionnaires. The parents are also asked to complete a questionnaire.
Measured: day of enrollment
Explore the possible links between the measured concepts
Patients are asked to complete quality of life questionnaires. The parents are also asked to complete a questionnaire. These questionnaires will then be analysed in order to check for possible links between the secondary outcome measures wirtten above.
Measured: day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startJul 2011
- Primary completionJan 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gronnier Pascale, MD, Principal investigator, Groupment des Hôpitaux de l'Institut Catholique de LilleGueorguieva Iva, MD, Principal investigator, Centre Hospitalier Universitaire de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417909
- Sponsor's protocol ID
- RC-P0011
- Acronym
- QOL-ADOB
- Status last verified
- May 2015
- First submitted
- 13 Apr 2015
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Psychological Difficulties in Relation With the Weight of Teenagers
- ClinicalTrials.gov ID
- NCT02417909
- Acronym / sponsor ID
- QOL-ADOB / RC-P0011
- Conditions
- Obesity
- Keywords
- Obesity, quality of life, teenagers, psychological impact
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Apr 2015 (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.
Obesity is a major public heath issue. It may have various impacts on a patient's life by causing psychological problems, altering a patient's quality of life,etc. These led to the investigators' hypothesis which is examining the psychological dimensions of a teenager suffering for obesity.
Detailed description
There are two groups in this study : healthy volunteers and teenagers suffering from obesity.
Patients and healthy volunteers will come to the nutrition clinic center Naturalpha where the patient will complete a questionnaire. The included patients will also complete a questionnaire privately (without the presence of the parents), they will also be weighted and measured.
No further tests or questionnaires will be given after the enrollment day.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: questionnaires about quality of lifeThis group is composed of healthy teenagers that volunteered to participate in the trial and that will answer questionnaires about quality of life. Parents will anwser questionnaires too. |
| Obese teenagers | – | Other: questionnaires about quality of lifeThis group is composed of obese teenagers that have been recruited to participate in the trial and that will answer different questionnaires quality of life. Parents will anwser questionnaires too. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Two categories of teenagers will be included : obese teenagers and average weighted volonteers
Key inclusion criteria (6 listed)
- Patients aged between 11 and 16 years old at the moment of enrollment.
- Body Mass Index between the 1st and 2nd degree of the obesity zone (over the 97th percentile curve regarding corpulence curves of the Plan National Nutrition Santé (PNNS) based on the gender (boys/girls))
- The teenagers have an appointment in the pediatric unit of the Saint Vincent de Paul Hospital for an examination regarding excess weight
- Patients aged between 11 and 16 years old at the moment of enrollment
- Body Mass Index located between the 3rd and the 97th percentile on the corpulence curves of the PNNS
Key exclusion criteria (4 listed)
- Body Mass Index over the 97th percentile curve on the corpulence curves of the PNNS
- Handicapped teenagers
- Body Mass Index over the 97th percentile curve or under the 3rd percentile curve on the corpulence curves of the PNNS
- Handicapped, asthmatic, obese or diabetic teenagers
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 |
|---|---|---|
| questionnaires about quality of lifeall teenagers included in the trial and their parents must complete the questionnaires given of them the day of enrollment. | Other | Healthy volunteers, Obese teenagers |
Primary outcome
Compare the quality of life of obese and average weighted teenagers
Time frame: day of enrollment
patients are weighted, measured and are asked to complete quality of life questionnaires. The parents are also asked to complete a questionnaire. The questionnaires answered by the teenagers are KIDSCREEN; CES-D; STAI-C; PJNA; EPADV; EPCDV and EQRI, they will be analysed along with the questionnaires completed by the parents, inorder to compare the quality of life of obese and average weighted teenagers.
5 secondary outcomes
Compare psychopathologic symptoms (depression, anxiety and social anxiety) in both populations
Time frame: day of enrollement
Compare the satisfaction of the needs described in the theory of auto-determination in both populations
Time frame: day fo enrollment
Explore the link between endured stigmatisation and self esteem for obese teenagers
Time frame: day of enrollment
Explore the effect of the support of the needs described in the auto-determination theory and their link to endured stigmatisation, quality of life and self esteem, for obese teenagers.
Time frame: day of enrollment
Explore the possible links between the measured concepts
Time frame: day of enrollment
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 5 Aug 2015.
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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.
Gronnier Pascale, MD principal investigator
Groupment des Hôpitaux de l'Institut Catholique de Lille
Gueorguieva Iva, MD principal investigator
Centre Hospitalier Universitaire de Lille
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Lille Catholic University.
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 6 inclusion and 4 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 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Compare the quality of life of obese and average weighted teenagers (time frame: day of enrollment). 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 5 Aug 2015.