Course of Obesity and Extreme Obesity in Adolescents (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
Helmholtz Zentrum München
Information provided by (Responsible Party):
Prof. Dr. Martin Wabitsch, University of Ulm
ClinicalTrials.gov Identifier:
NCT01662271
First received: July 20, 2012
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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 21 years are eligible to participate. Participants will have a physical check-up 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.


Condition
Obesity
Extreme Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Course of Obesity and Extreme Obesity in Adolescents, in the Context of Different Treatment Options - a Longitudinal Prospective Observation Study

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • adherence with structured care [ Time Frame: 12 months after subject inclusion ] [ Designated as safety issue: No ]
    The percentage of subjects that comply with the structured follow up program will be calculated once a year.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).

  • percentage of subjects that undergo the recommended diagnostic procedures [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: No ]
    Medically appropriate diagnostic procedures will be recommended to the patients, and the percentage of subjects that undergo the recommended diagnostic procedures will be documented.

  • changes in somatic co-morbidities [ Time Frame: every 12 months for 9 years ] [ Designated as safety issue: No ]
    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).

  • changes in psychiatric co-morbidities [ Time Frame: every 12 months for 9 years ] [ Designated as safety issue: No ]
    Incidences and changes of psychiatric co-morbidities will be assessed via validated patient questionnaires once a year.

  • compliance with treatment of somatic co-morbidities [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: No ]
    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).

  • compliance with treatment of psychiatric co-morbidities [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: No ]
    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).

  • changes in health related quality of life [ Time Frame: every 12 months for 9 years ] [ Designated as safety issue: No ]
    Assessed via validated questionnaires (EQ5D, DISABKIDS).

  • changes in socio-economic status [ Time Frame: every 12 months for 9 years ] [ Designated as safety issue: No ]
    Assessed via standardized questionnaires (modified after KIGGS and TeenLABS).

  • incidence of extreme obesity [ Time Frame: every 12 months for 9 years ] [ Designated as safety issue: No ]
    The incidence of extreme obesity (BMI ≥35kg/m2) will be determined in the group of adolescents with moderate obesity (BMI 30-34.9kg/m2).

  • changes in BMI-SDS [ Time Frame: every 6 months for 9 years ] [ Designated as safety issue: No ]
    Height and weight will be measured with standardized instruments and BMI-SDS will be calculated.

  • predictors of the above outcomes [ Time Frame: every 12 months for 9 years ] [ Designated as safety issue: No ]
    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 vie multiple regression analyses.

  • adherence with structured care [ Time Frame: every 12 months from 2-9 years post enrollment ] [ Designated as safety issue: No ]
    The percentage of subjects that comply with the structured follow up program will be calculated once a year.


Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 600
Study Start Date: July 2012
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts
adolescents with extreme obesity
BMI ≥35kg/m2
adolescents with obesity
BMI 30-34.9kg/m2

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:

  1. 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).
  2. 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).
  3. 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).
  4. 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 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. 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 biannually, 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.

  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
  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: NCT01662271

Contacts
Contact: Anja Moss, Dr. biol. hum. +49 7031 500 57401 ja-studie@uni-ulm.de
Contact: Belinda S Lennerz, Dr. med. +49 7031 500 57401 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
Helmholtz Zentrum München
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
  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: NCT01662271     History of Changes
Other Study ID Numbers: U1111-1131-4384e, DRKS00004172, 01GI1120A
Study First Received: July 20, 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
youth with extreme obesity
weight loss

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

ClinicalTrials.gov processed this record on October 23, 2014