ObesityYESNCT01662271
Course of Obesity and Extreme Obesity in Adolescents
An observational study of Obesity and Extreme Obesity, run by Prof. Dr. Martin Wabitsch at 5 sites in Germany.
Trial summary
The rate of adolescent extreme obesity is rapidly rising, and impacting quality of life, psychosocial situation, and health of the affected youth. However, as few of these adolescents seek medical care, little is known about the longitudinal course of adolescent extreme obesity. 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 Jul 2023
- 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 listed.
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: Course of Obesity and Extreme Obesity in Adolescents, in the Context of Different Treatment Options - a Longitudinal Prospective Observation Study
The rate of adolescent extreme obesity is rapidly rising, and impacting quality of life, psychosocial situation, and health of the affected youth. However, as few of these adolescents seek medical care, little is known about the longitudinal course of adolescent extreme obesity.
In this study, the investigators aim to provide structured care for adolescents with obesity and extreme obesity over a prolonged period of time, and to gain information on the course of obesity and the success of different treatment options. The study is a subproject of the "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care", 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. 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 have a physical check-up every 12 months (initially every 6 months), complete questionnaires on their health, socioeconomic status and wellbeing, and are offered blood test and diagnostic procedures to assess comorbidities. Participants are offered support and guidance for social and vocational integration. The study will evaluate and inform treatment and support options for adolescents with extreme obesity.
Read the detailed description
Little is known about the longitudinal course of adolescent extreme obesity. In this multicenter study, the investigators aim to enroll adolescents with extreme obesity (BMI ≥ 35kg/m2) in a 9 year longitudinal, prospective observation that will reveal information on the course of obesity and the success of different treatment options. Adolescents with more moderate degrees of obesity (BMI 30-34,9kg/m2) will serve as a control group. The project builds on the Consortium "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care", short: "Youth with extreme obesity Study (YES)", which comprises the recruitment and characterization of obese youth from different healthcare- and non healthcare settings, 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, the investigators have formulated the following a priori hypotheses in regards to the longitudinal observation study:
- Youth with extreme obesity (BMI ≥ 35kg/m2) achieve lower adherence with the structured care program compared to adolescents with more moderate degrees of obesity (BMI 30-34,9kg/m2).
- Youth with extreme obesity (BMI ≥ 35kg/m2) are less likely to achieve and sustain weight loss over a prolonged period of time, compared to adolescents with more moderate degrees of obesity (BMI 30-34,9kg/m2).
- Youth with extreme obesity (BMI ≥ 35kg/m2) are harder to integrate in the job market compared to youth with more moderate degrees of obesity (BMI 30-34,9kg/m2).
- Youth with extreme obesity (BMI ≥ 35kg/m2) have higher incidence and severity of co-morbidities compared to youth with more moderate degrees of obesity (BMI 30-34,9kg/m2).
The investigators aim to recruit a total of 600 adolescents age 14 to 24.9 years (initial age up to 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. 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. Adolescent will be examined annually (initially examinations were biannually, this was changed in an amendment in December 2014), and testing will include an array of standardized questionnaires and validated instruments to assess health, psycho-social situation, psychiatric co-morbidities and health related quality of life, as well as a physical examination, laboratory tests, and screenings for orthopedic co-morbidities and sleep apnea. Participants are offered support and guidance in regards to social and vocational integration with the aim of improving self esteem and social functioning. Data will be entered in an extended version of the "German National Register for Longitudinal Research on Childhood Obesity". We will perform sub-analyses based on the treatment options these youths have followed The project will reveal the acceptance and outcomes of a structured healthcare program for adolescents with extreme obesity and 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, youth with extreme obesity, weight loss
- Medical subject headings
- Obesity, Obesity, Morbid, Weight Loss
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 |
|---|---|---|
| adolescents with extreme obesity | BMI ≥35kg/m2 | |
| adolescents with obesity | BMI 30-34.9kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence with structured care
The percentage of subjects that comply with the structured follow up program will be calculated once a year.
Measured: 12 months after subject inclusion
Secondary outcomes (12)
percentage of subjects that can be integrated into the job-market or into an apprenticeship training position
The percentage of subjects who can be integrated into the job-market or into an apprenticeship training position will be determined via standardized questionnaire (modified after KIGGS and TeenLABS).
Measured: every 12 months for 9 years
percentage of subjects that undergo the recommended diagnostic procedures
Medically appropriate diagnostic procedures will be recommended to the patients, and the percentage of subjects that undergo the recommended diagnostic procedures will be documented.
Measured: every 12 months for 9 years
changes in somatic co-morbidities
Incidences and changes of somatic co-morbidities will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires (modified after KIGGS and TeenLABS).
Measured: every 12 months for 9 years
changes in psychiatric co-morbidities
Incidences and changes of psychiatric co-morbidities will be assessed via validated patient questionnaires once a year.
Measured: every 12 months for 9 years
compliance with treatment of somatic co-morbidities
Appropriate treatment of the diagnosed somatic co-morbidities will be offered to all subjects. The percentage of subjects who comply with such therapy will be assessed via standardized questionnaire (modified after KIGGS and TeenLABS).
Measured: every 12 months for 9 years
compliance with treatment of psychiatric co-morbidities
Appropriate treatment of the diagnosed psychiatric co-morbidities will be offered to all subjects. The percentage of subjects who comply with such therapy will be assessed via standardized questionnaire (modified after KIGGS and TeenLABS).
Measured: every 12 months for 9 years
changes in health related quality of life
Assessed via validated questionnaires (EQ5D, DISABKIDS).
Measured: every 12 months for 9 years
changes in socio-economic status
Assessed via standardized questionnaires (modified after KIGGS and TeenLABS).
Measured: every 12 months for 9 years
incidence of extreme obesity
The incidence of extreme obesity (BMI ≥35kg/m2) will be determined in the group of adolescents with moderate obesity (BMI 30-34.9kg/m2).
Measured: every 12 months for 9 years
changes in BMI-SDS
Height and weight will be measured with standardized instruments and BMI-SDS will be calculated.
Measured: every 12 months for 9 years
predictors of the above outcomes
Psycho-social, psychiatric, and medical variables will be assessed via standardized physical examination, laboratory and apparative tests, standardized patient questionnaires (modified after KIGGS and TeenLABS), and validated psychiatric instruments once a year, and correlation with the outcome variable will be assessed via multiple regression analyses.
Measured: every 12 months for 9 years
adherence with structured care
The percentage of subjects that comply with the structured follow up program will be calculated once a year.
Measured: every 12 months from 2-9 years post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2023
- Study completionJul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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, Helmholtz Zentrum München
- 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 Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662271
- Sponsor's protocol ID
- U1111-1131-4384e
- Other IDs
- DRKS00004172, 01GI1120A
- Acronym
- YES
- Status last verified
- May 2024
- First submitted
- 20 Jul 2012
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wabitsch 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Course of Obesity and Extreme Obesity in Adolescents, in the Context of Different Treatment Options - a Longitudinal Prospective Observation Study
- ClinicalTrials.gov ID
- NCT01662271
- Acronym / sponsor ID
- YES / U1111-1131-4384e
- Conditions
- Obesity, Extreme Obesity
- Keywords
- obesity, adiposity, psychosocial, healthcare, co-morbidities, youth with extreme obesity, weight loss
- 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, Helmholtz Zentrum München
- Study start
- Jul 2012 (actual)
- Primary completion
- Jul 2023 (actual)
- Study completion
- Jul 2023 (actual)
- First posted
- 10 Aug 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.
The rate of adolescent extreme obesity is rapidly rising, and impacting quality of life, psychosocial situation, and health of the affected youth. However, as few of these adolescents seek medical care, little is known about the longitudinal course of adolescent extreme obesity.
In this study, the investigators aim to provide structured care for adolescents with obesity and extreme obesity over a prolonged period of time, and to gain information on the course of obesity and the success of different treatment options. The study is a subproject of the "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care", 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. 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 have a physical check-up every 12 months (initially every 6 months), complete questionnaires on their health, socioeconomic status and wellbeing, and are offered blood test and diagnostic procedures to assess comorbidities. Participants are offered support and guidance for social and vocational integration. The study will evaluate and inform treatment and support options for adolescents with extreme obesity.
Detailed description
Little is known about the longitudinal course of adolescent extreme obesity. In this multicenter study, the investigators aim to enroll adolescents with extreme obesity (BMI ≥ 35kg/m2) in a 9 year longitudinal, prospective observation that will reveal information on the course of obesity and the success of different treatment options. Adolescents with more moderate degrees of obesity (BMI 30-34,9kg/m2) will serve as a control group. The project builds on the Consortium "Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care", short: "Youth with extreme obesity Study (YES)", which comprises the recruitment and characterization of obese youth from different healthcare- and non healthcare settings, 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, the investigators have formulated the following a priori hypotheses in regards to the longitudinal observation study:
- Youth with extreme obesity (BMI ≥ 35kg/m2) achieve lower adherence with the structured care program compared to adolescents with more moderate degrees of obesity (BMI 30-34,9kg/m2).
- Youth with extreme obesity (BMI ≥ 35kg/m2) are less likely to achieve and sustain weight loss over a prolonged period of time, compared to adolescents with more moderate degrees of obesity (BMI 30-34,9kg/m2).
- Youth with extreme obesity (BMI ≥ 35kg/m2) are harder to integrate in the job market compared to youth with more moderate degrees of obesity (BMI 30-34,9kg/m2).
- Youth with extreme obesity (BMI ≥ 35kg/m2) have higher incidence and severity of co-morbidities compared to youth with more moderate degrees of obesity (BMI 30-34,9kg/m2).
The investigators aim to recruit a total of 600 adolescents age 14 to 24.9 years (initial age up to 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. 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. Adolescent will be examined annually (initially examinations were biannually, this was changed in an amendment in December 2014), and testing will include an array of standardized questionnaires and validated instruments to assess health, psycho-social situation, psychiatric co-morbidities and health related quality of life, as well as a physical examination, laboratory tests, and screenings for orthopedic co-morbidities and sleep apnea. Participants are offered support and guidance in regards to social and vocational integration with the aim of improving self esteem and social functioning. Data will be entered in an extended version of the "German National Register for Longitudinal Research on Childhood Obesity". We will perform sub-analyses based on the treatment options these youths have followed The project will reveal the acceptance and outcomes of a structured healthcare program for adolescents with extreme obesity and 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 |
|---|---|---|
| adolescents with extreme obesity | – | –BMI ≥35kg/m2 |
| adolescents with obesity | – | –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 (0 listed)
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
adherence with structured care
Time frame: 12 months after subject inclusion
The percentage of subjects that comply with the structured follow up program will be calculated once a year.
12 secondary outcomes
percentage of subjects that can be integrated into the job-market or into an apprenticeship training position
Time frame: every 12 months for 9 years
percentage of subjects that undergo the recommended diagnostic procedures
Time frame: every 12 months for 9 years
changes in somatic co-morbidities
Time frame: every 12 months for 9 years
changes in psychiatric co-morbidities
Time frame: every 12 months for 9 years
compliance with treatment of somatic co-morbidities
Time frame: every 12 months for 9 years
compliance with treatment of psychiatric co-morbidities
Time frame: every 12 months for 9 years
changes in health related quality of life
Time frame: every 12 months for 9 years
changes in socio-economic status
Time frame: every 12 months for 9 years
incidence of extreme obesity
Time frame: every 12 months for 9 years
changes in BMI-SDS
Time frame: every 12 months for 9 years
predictors of the above outcomes
Time frame: every 12 months for 9 years
adherence with structured care
Time frame: every 12 months from 2-9 years post 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 8 May 2024.
- 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 0 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 8 May 2024. 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?
adherence with structured care (time frame: 12 months after subject inclusion). 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 NCT01662271, which also lists 1 linked publication.
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 8 May 2024.