ObesityYESNCT01625325
Identification and Characterization of Youth With Extreme Obesity
An observational study of Obesity and Extreme Obesity, run by Prof. Dr. Martin Wabitsch at 5 sites in Germany.
Trial summary
While obese and extremely obese youth are at increased risk of health complications, especially the extremely obese group rarely seek medical care. One of the underlying reasons might be the lack of adequate treatment options. Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Extreme Obesity
- How many people
- 429 participants
- Where
- 5 sitesGermany
- Study dates
- Jul 2012to Dec 2014
- 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 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects will be recruited from the general population through different healthcare- and non healthcare settings to ascertain the inclusion of treatment-seeking and non treatment-seeking individuals. Healthcare settings include university based obesity clinics, physician offices and health insurance agencies. Non-healthcare settings include schools, job centers, and employment agencies.
Who may be able to join
- BMI ≥30kg/m2
- sufficient German language skills
Who cannot join
- none
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Ambulatory Obesity Program, Charité University, Berlin
Berlin, 13353
Vestische Kinderklinik, University of Witten/Herdecke
Datteln
University Duisburg-Essen
Essen, 45147
University Hospital Leipzig
Leipzig, 04103
Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic
Ulm, 89075
About this study
Official title: Medical and Psychosocial Implications of Adolescent Extreme Obesity - Acceptance and Effects of Structured Care Study, Subproject 1
While obese and extremely obese youth are at increased risk of health complications, especially the extremely obese group rarely seek medical care. One of the underlying reasons might be the lack of adequate treatment options. This study is a subproject of the "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care study", short: "Youth with Extreme obesity Study (YES)", which aims at improving the medical care and social support structures for youth with obesity and extreme obesity in Germany. In this subproject, information on the causes and consequences of extreme obesity will be gathered via questionnaires and medical examinations.
Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years (initially up to 21 years) are eligible to participate. Participants will be asked to complete a series of questionnaires on their general health, psychosocial situation and wellbeing in 2-3 sessions. They will be offered a thorough medical examination comprising a general check-up, a fasting blood draw and oral glucose tolerance test, a focused orthopaedic examination, a sleep apnea screening, and an ultrasound of the liver. The aim of the study is to elicit the acceptance of diagnostic and therapeutic procedures, and to assess the frequency of co-morbidities in obese and extremely obese youth. This knowledge will optimize medical treatment and support options. Interested participants will be invited to participate in further steps of YES, which entail medical care and psycho-social support.
Read the detailed description
In this multicenter study, we aim to recruit adolescents from various medical and non-medical settings and examine their acceptance of diagnostic and subsequent treatment procedures. We will compare the prevalence rates and severity of co-morbidities between adolescents with extreme obesity (BMI ≥35kg/m2)and those with less severe obesity (BMI 30-34.9kg/m2). This project is part of the "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care study", short: "Youth with extreme obesity Study (YES)", which also comprises a randomized controlled trial to investigate a novel intervention targeted at improving quality of life and social functioning of extremely obese adolescents, a structured prospective evaluation of adolescent bariatric surgery, and economic assessments of the financial burden of extreme adolescent obesity on the healthcare system.
Based on the current state of knowledge, we have formulated the following hypotheses in regards to baseline characteristics:
- The prevalence of somatic, psychiatric and psycho-social co-morbidities is higher, and health related quality of life is lower in extremely obese youth compared to the control group.
- The prevalence of somatic co-morbidities is equal in treatment-seeking and non treatment-seeking youth.
- The prevalence of psychiatric co-morbidities is higher and health related quality of life is lower in treatment-seeking compared to non treatment-seeking youth.
- The acceptance of diagnostic and therapeutic procedures is lower in extremely obese youth compared to the control group.
- The acceptance of diagnostic and therapeutic procedures is lower in non treatment-seeking- compared to treatment-seeking youth.
- Socio-economic status, intelligence and educational status are predictors of treatment seeking behaviour and of the acceptance of diagnostic and therapeutic procedures.
The five participating university centers are distributed across 4 geographic regions in the North (Berlin), in the West (Essen/Datteln), in the East (Leipzig) and in the South (Ulm) of Germany, and will therefore render data that are representative of Germany as a whole. We will recruit a total of 600 adolescents age 14 to 24.9 years (initial age 21 years, changed in an amendment in February 2013) with extreme obesity (BMI ≥ 35 kg/m2) and 600 adolescents with obesity (BMI 30-34.9 kg/m2) over a 24 months period. Baseline assessments include an array of standardized questionnaires and validated instruments to assess health, psycho-social situation, psychiatric co-morbidities and health related quality of life (in the amendment in February 2013, the scope of psychosocial questions was reduced), as well as a physical examination, laboratory tests, liver ultrasound, and screenings for orthopedic co-morbidities and sleep apnea. Subjects who participate in the baseline examination will be invited to participate in the subsequent components of YES.
The project will reveal comorbidity rates and psycho-social situation, and demonstrate the acceptance and outcomes of a structured healthcare program for adolescents with extreme obesity. The planned subsequent longitudinal study will provide unique information on the medical and psychosocial development of adolescents with extreme obesity in Germany.
- Conditions
- Obesity, Extreme Obesity
- Keywords
- obesity, adiposity, psychosocial, healthcare, co-morbidities, low key intervention, quality of life
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| extremely obese | BMI ≥35kg/m2 | |
| obese | BMI 30-34.9kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects that participate in the fasting blood draw
Subjects will be offered a diagnostic blood draw. The percentage of subjects that undergo this blood draw will be calculated.
Measured: baseline
Secondary outcomes (10)
Predictors of the acceptance of the diagnostic procedures
Measured: baseline
Prevalence of obesity associated psychiatric co-morbidities
Co-morbidities will be assessed via validated patient questionnaires.
Measured: baseline
Percentage of patients that accept treatment of somatic co-morbidities
Appropriate medical treatment of the diagnosed somatic co-morbidities will be offered to all subjects. The percentage of subjects who initiate such therapy will be calculated.
Measured: baselin
Predictors of acceptance of treatment of co-morbidities
Measured: baseline
Health related quality of life
assessed by validated questionnaire EQ5D
Measured: baseline
Socio-economic status
Assessed by standardized questionnaire.
Measured: baseline
Prevalence of obesity associated somatic co-morbidities
Co-morbidities will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires.
Measured: baseline
Percentage of patients that accept treatment of psychiatric co-morbidities
Appropriate medical treatment of the diagnosed psychiatric co-morbidities will be offered to all subjects. The percentage of subjects who initiate such therapy will be calculated.
Measured: baseline
Percentage of subjects that initiate a standardized low key intervention
All subjects will be offered the participation in a low key intervention as described in subproject two. The percentage of patients that accept and initiate this intervention will be calculated.
Measured: baseline
Percentage of subjects that participate in diagnostic procedures.
Subjects will be offered a diagnostic liver ultrasound, sleep apnea screening, orthopedic screening, and an array of questionnaires to assess somatic- and psychiatric co-morbidities, psycho-social situation and health related quality of life. The percentage of subjects that comply with these diagnostic procedures beyond the initial visit will be calculated.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Martin Wabitsch
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witten/Herdecke, Charite University, Berlin, Germany, University of Leipzig, Universität Duisburg-Essen
- Responsible party
- Sponsor-investigator, Prof. Dr. Martin Wabitsch, University of Ulm
- Investigators
- Martin Wabitsch, Prof. Dr. med., Study chair, University of UlmSusanna Wiegand, Dr. med., Principal investigator, Charite University, Berlin, GermanyThomas Reinehr, Prof. Dr. med., Principal investigator, University of Witten/HerdeckeJohannes Hebebrand, Prof. Dr. med., Principal investigator, Universität Duisburg-EssenWieland Kiess, Prof. Dr. med., Principal investigator, University of LeipzigReinhard Holl, Prof. Dr. med., Principal investigator, University of UlmAnja Moss, Dr. biol. hum., Study director, University of UlmBelinda S Lennerz, Dr. med., Study director, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625325
- Sponsor's protocol ID
- U1111-1131-4384a
- Other IDs
- DRKS00004172, 01GI1120A
- Acronym
- YES
- Status last verified
- Jun 2018
- First submitted
- 19 Jun 2012
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Felix J, Stark R, Teuner C, Leidl R, Lennerz B, Brandt S, von Schnurbein J, Moss A, Bollow E, Sergeyev E, Muhlig Y, Wiegand S, Holl RW, Reinehr T, Kiess W, Scherag A, Hebebrand J, Wabitsch M, Holle R. Health related quality of life associated with extreme obesity in adolescents - results from the baseline evaluation of the YES-study. Health Qual Life Outcomes. 2020 Mar 5;18(1):58. doi: 10.1186/s12955-020-01309-z.
PubMed 32138734Wabitsch M, Moss A, Reinehr T, Wiegand S, Kiess W, Scherag A, Holl R, Holle R, Hebebrand J. Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care, short: Youth with Extreme Obesity Study (YES). BMC Public Health. 2013 Aug 29;13:789. doi: 10.1186/1471-2458-13-789.
PubMed 23987123
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical and Psychosocial Implications of Adolescent Extreme Obesity - Acceptance and Effects of Structured Care Study, Subproject 1
- ClinicalTrials.gov ID
- NCT01625325
- Acronym / sponsor ID
- YES / U1111-1131-4384a
- Conditions
- Obesity, Extreme Obesity
- Keywords
- obesity, adiposity, psychosocial, healthcare, co-morbidities, low key intervention, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Prof. Dr. Martin WabitschUniversity, hospital or other
- Collaborators
- University of Witten/Herdecke, Charite University, Berlin, Germany, University of Leipzig, Universität Duisburg-Essen
- Study start
- Jul 2012 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Jun 2012 (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.
While obese and extremely obese youth are at increased risk of health complications, especially the extremely obese group rarely seek medical care. One of the underlying reasons might be the lack of adequate treatment options. This study is a subproject of the "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care study", short: "Youth with Extreme obesity Study (YES)", which aims at improving the medical care and social support structures for youth with obesity and extreme obesity in Germany. In this subproject, information on the causes and consequences of extreme obesity will be gathered via questionnaires and medical examinations.
Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and 24.9 years (initially up to 21 years) are eligible to participate. Participants will be asked to complete a series of questionnaires on their general health, psychosocial situation and wellbeing in 2-3 sessions. They will be offered a thorough medical examination comprising a general check-up, a fasting blood draw and oral glucose tolerance test, a focused orthopaedic examination, a sleep apnea screening, and an ultrasound of the liver. The aim of the study is to elicit the acceptance of diagnostic and therapeutic procedures, and to assess the frequency of co-morbidities in obese and extremely obese youth. This knowledge will optimize medical treatment and support options. Interested participants will be invited to participate in further steps of YES, which entail medical care and psycho-social support.
Detailed description
In this multicenter study, we aim to recruit adolescents from various medical and non-medical settings and examine their acceptance of diagnostic and subsequent treatment procedures. We will compare the prevalence rates and severity of co-morbidities between adolescents with extreme obesity (BMI ≥35kg/m2)and those with less severe obesity (BMI 30-34.9kg/m2). This project is part of the "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care study", short: "Youth with extreme obesity Study (YES)", which also comprises a randomized controlled trial to investigate a novel intervention targeted at improving quality of life and social functioning of extremely obese adolescents, a structured prospective evaluation of adolescent bariatric surgery, and economic assessments of the financial burden of extreme adolescent obesity on the healthcare system.
Based on the current state of knowledge, we have formulated the following hypotheses in regards to baseline characteristics:
- The prevalence of somatic, psychiatric and psycho-social co-morbidities is higher, and health related quality of life is lower in extremely obese youth compared to the control group.
- The prevalence of somatic co-morbidities is equal in treatment-seeking and non treatment-seeking youth.
- The prevalence of psychiatric co-morbidities is higher and health related quality of life is lower in treatment-seeking compared to non treatment-seeking youth.
- The acceptance of diagnostic and therapeutic procedures is lower in extremely obese youth compared to the control group.
- The acceptance of diagnostic and therapeutic procedures is lower in non treatment-seeking- compared to treatment-seeking youth.
- Socio-economic status, intelligence and educational status are predictors of treatment seeking behaviour and of the acceptance of diagnostic and therapeutic procedures.
The five participating university centers are distributed across 4 geographic regions in the North (Berlin), in the West (Essen/Datteln), in the East (Leipzig) and in the South (Ulm) of Germany, and will therefore render data that are representative of Germany as a whole. We will recruit a total of 600 adolescents age 14 to 24.9 years (initial age 21 years, changed in an amendment in February 2013) with extreme obesity (BMI ≥ 35 kg/m2) and 600 adolescents with obesity (BMI 30-34.9 kg/m2) over a 24 months period. Baseline assessments include an array of standardized questionnaires and validated instruments to assess health, psycho-social situation, psychiatric co-morbidities and health related quality of life (in the amendment in February 2013, the scope of psychosocial questions was reduced), as well as a physical examination, laboratory tests, liver ultrasound, and screenings for orthopedic co-morbidities and sleep apnea. Subjects who participate in the baseline examination will be invited to participate in the subsequent components of YES.
The project will reveal comorbidity rates and psycho-social situation, and demonstrate the acceptance and outcomes of a structured healthcare program for adolescents with extreme obesity. The planned subsequent longitudinal study will provide unique information on the medical and psychosocial development of adolescents with extreme obesity in Germany.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extremely obese | – | –BMI ≥35kg/m2 |
| obese | – | –BMI 30-34.9kg/m2 |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects will be recruited from the general population through different healthcare- and non healthcare settings to ascertain the inclusion of treatment-seeking and non treatment-seeking individuals. Healthcare settings include university based obesity clinics, physician offices and health insurance agencies. Non-healthcare settings include schools, job centers, and employment agencies.
Key inclusion criteria (2 listed)
- BMI ≥30kg/m2
- sufficient German language skills
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of subjects that participate in the fasting blood draw
Time frame: baseline
Subjects will be offered a diagnostic blood draw. The percentage of subjects that undergo this blood draw will be calculated.
10 secondary outcomes
Predictors of the acceptance of the diagnostic procedures
Time frame: baseline
Prevalence of obesity associated psychiatric co-morbidities
Time frame: baseline
Percentage of patients that accept treatment of somatic co-morbidities
Time frame: baselin
Predictors of acceptance of treatment of co-morbidities
Time frame: baseline
Health related quality of life
Time frame: baseline
Socio-economic status
Time frame: baseline
Prevalence of obesity associated somatic co-morbidities
Time frame: baseline
Percentage of patients that accept treatment of psychiatric co-morbidities
Time frame: baseline
Percentage of subjects that initiate a standardized low key intervention
Time frame: baseline
Percentage of subjects that participate in diagnostic procedures.
Time frame: baseline
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 13 Jun 2018.
- Derived from this study: PubMed 32138734Felix J, Stark R, Teuner C, Leidl R, Lennerz B, Brandt S, von Schnurbein J, Moss A, Bollow E, Sergeyev E, Muhlig Y, Wiegand S, Holl RW, Reinehr T, Kiess W, Scherag A, Hebebrand J, Wabitsch M, Holle R. Health related quality of life associated with extreme obesity in adolescents - results from the baseline evaluation of the YES-study. Health Qual Life Outcomes. 2020 Mar 5;18(1):58. doi: 10.1186/s12955-020-01309-z.
- Derived from this study: PubMed 23987123Wabitsch M, Moss A, Reinehr T, Wiegand S, Kiess W, Scherag A, Holl R, Holle R, Hebebrand J. Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care, short: Youth with Extreme Obesity Study (YES). BMC Public Health. 2013 Aug 29;13:789. doi: 10.1186/1471-2458-13-789.
- study homepageLink provided by the sponsor.
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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.
Martin Wabitsch, Prof. Dr. med. study chair
University of Ulm
Susanna Wiegand, Dr. med. principal investigator
Charite University, Berlin, Germany
Thomas Reinehr, Prof. Dr. med. principal investigator
University of Witten/Herdecke
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Extreme Obesity, run by Prof. Dr. Martin Wabitsch at 5 sites in Germany.
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 2 inclusion and 1 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 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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?
Percentage of subjects that participate in the fasting blood draw (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01625325, which also lists 2 linked publications.
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 13 Jun 2018.