Identification and Characterization of Youth With Extreme Obesity (YES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Ulm
Sponsor:
Collaborators:
University of Witten/Herdecke
Charite University, Berlin, Germany
University of Leipzig
Universität Duisburg-Essen
Information provided by (Responsible Party):
Prof. Dr. Martin Wabitsch, University of Ulm
ClinicalTrials.gov Identifier:
NCT01625325
First received: June 19, 2012
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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 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.


Condition
Obesity
Extreme Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medical and Psychosocial Implications of Adolescent Extreme Obesity - Acceptance and Effects of Structured Care Study, Subproject 1

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Percentage of subjects that participate in the fasting blood draw [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Subjects will be offered a diagnostic blood draw. The percentage of subjects that undergo this blood draw will be calculated.


Secondary Outcome Measures:
  • Predictors of the acceptance of the diagnostic procedures [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Prevalence of obesity associated psychiatric co-morbidities [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Co-morbidities will be assessed via validated patient questionnaires.

  • Percentage of patients that accept treatment of somatic co-morbidities [ Time Frame: baselin ] [ Designated as safety issue: No ]
    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.

  • Predictors of acceptance of treatment of co-morbidities [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: baseline ] [ Designated as safety issue: No ]
    assessed by validated questionnaire EQ5D

  • Socio-economic status [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Assessed by standardized questionnaire.

  • Prevalence of obesity associated somatic co-morbidities [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Co-morbidities will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires.

  • Percentage of patients that accept treatment of psychiatric co-morbidities [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Percentage of subjects that initiate a standardized low key intervention [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Percentage of subjects that participate in diagnostic procedures. [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Sanples of fasting plasma, serum, DNA, and urine will be retained.


Estimated Enrollment: 1200
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
extremely obese
BMI ≥35kg/m2
obese
BMI 30-34.9kg/m2

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:

  1. 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.
  2. The prevalence of somatic co-morbidities is equal in treatment-seeking and non treatment-seeking youth.
  3. 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.
  4. The acceptance of diagnostic and therapeutic procedures is lower in extremely obese youth compared to the control group.
  5. The acceptance of diagnostic and therapeutic procedures is lower in non treatment-seeking- compared to treatment-seeking youth.
  6. 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 21 years 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, 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.

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • BMI ≥30kg/m2
  • sufficient German language skills

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625325

Contacts
Contact: Anja Moss, Dr. biol. hum. +49 731 500 57401 ja-studie@uni-ulm.de
Contact: Belinda S Lennerz, Dr. med. +49 731 500 5740 ja-studie@uni-ulm.de

Locations
Germany
Ambulatory Obesity Program, Charité University, Berlin Recruiting
Berlin, Germany, 13353
Contact: Annika Bickenbach, Dr.med.    +49 30 450 566 889    babeluga@charite.de   
Principal Investigator: Susanna Wiegand, Dr. med.         
Sub-Investigator: Annika Bickenbach, Dr. med.         
Vestische Kinderklinik, University of Witten/Herdecke Recruiting
Datteln, Germany
Contact: Anke Schaefer    +49 2363 975 349    A.Schaefer@kinderklinik-datteln.de   
Principal Investigator: Thomas Reinehr, Prof. Dr. med.         
Sub-Investigator: Barbara Wolters, D. med.         
University Duisburg-Essen Recruiting
Essen, Germany, 45147
Contact: Johannes Hebebrand, Prof. Dr.med.    +49 201 8707 466    ja-studie@uni-due.de   
Principal Investigator: Johannes Hebebrand, Prof. Dr.med.         
Sub-Investigator: André Scherag, Dr. rer. physiol.         
Sub-Investigator: Claudia Ose         
Sub-Investigator: Yvonne Mühlig, Dipl. Psych.         
University Hospital Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Madlen Neef    +49 341 9726000    Madlen.Neef@medizin.uni-leipzig.de   
Principal Investigator: Wieland Kiess, Prof. Dr. med.         
Sub-Investigator: Madlen Neef         
Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic Recruiting
Ulm, Germany, 89075
Contact: Anja S Moss, Dr. biol. hum.    +49 7031 500 57401    ja-studie@uni-ulm.de   
Contact: Belinda Lennerz, Dr. med.    +49 7031 500 57401    ja-studie@uni-ulm.de   
Principal Investigator: Martin Wabitsch, Prof. Dr. med.         
Sub-Investigator: Belinda S Lennerz, Dr. med.         
Sub-Investigator: Anja Moss, Dr. hum. biol.         
Sponsors and Collaborators
Prof. Dr. Martin Wabitsch
University of Witten/Herdecke
Charite University, Berlin, Germany
University of Leipzig
Universität Duisburg-Essen
Investigators
Study Chair: Martin Wabitsch, Prof. Dr. med. University of Ulm
Principal Investigator: Susanna Wiegand, Dr. med. Charite University, Berlin, Germany
Principal Investigator: Thomas Reinehr, Prof. Dr. med. University of Witten/Herdecke
Principal Investigator: Johannes Hebebrand, Prof. Dr. med. Universität Duisburg-Essen
Principal Investigator: Wieland Kiess, Prof. Dr. med. University of Leipzig
Principal Investigator: Reinhard Holl, Prof. Dr. med. University of Ulm
Study Director: Anja Moss, Dr. biol. hum. University of Ulm
Study Director: Belinda S Lennerz, Dr. med. University of Ulm
  More Information

Additional Information:
No publications provided by University of Ulm

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Martin Wabitsch, Division Chief Pediatric Endocrinology and Diabetology, University of Ulm
ClinicalTrials.gov Identifier: NCT01625325     History of Changes
Other Study ID Numbers: U1111-1131-4384a, DRKS00004172, 01GI1120A
Study First Received: June 19, 2012
Last Updated: October 22, 2013
Health Authority: Germany: Federal Ministry of Education and Research
Germany: Ethics Commission

Keywords provided by University of Ulm:
obesity, adiposity, psychosocial, healthcare, co-morbidities, low key intervention, quality of life

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014