Course of Obesity and Extreme Obesity in Adolescents

NCT01662271 | Completed DMC

• 3 other identifiers: U1111-1131-4384eDRKS0000417201GI1120A
• Study Type: observational
• Target: 429
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Obesity; Extreme Obesity

Keywords

obesity; adiposity; psychosocial; healthcare; co-morbidities; youth with extreme obesity; weight loss

Outcome Measures

Primary Outcomes (1)

• adherence with structured care

  The percentage of subjects that comply with the structured follow up program will be calculated once a year.

  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

  every 12 months for 9 years

• percentage of subjects that undergo the recommended diagnostic procedures

  every 12 months for 9 years

• changes in somatic co-morbidities

  every 12 months for 9 years

• changes in psychiatric co-morbidities

  every 12 months for 9 years

• compliance with treatment of somatic co-morbidities

  every 12 months for 9 years

Study Arms (2)

adolescents with extreme obesity

BMI ≥35kg/m2

adolescents with obesity

BMI 30-34.9kg/m2

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Prof. Dr. Martin Wabitsch: lead
• University of Witten/Herdecke: collaborator
• Charite University, Berlin, Germany: collaborator
• University of Leipzig: collaborator
• Universität Duisburg-Essen: collaborator
• Helmholtz Zentrum München: collaborator

Study Sites (5)

Ambulatory Obesity Program, Charité University, Berlin

Berlin, 13353, Germany

Location

Vestische Kinderklinik, University of Witten/Herdecke

Datteln, Germany

Location

University Duisburg-Essen

Essen, 45147, Germany

Location

University Hospital Leipzig

Leipzig, 04103, Germany

Location

Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic

Ulm, 89075, Germany

Location

Related Publications (1)

• 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.

  PMID: 23987123 DERIVED

Related Links

• study homepage

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Martin Wabitsch, Prof. Dr. med.

  University of Ulm

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Division Chief Pediatric Endocrinology and Diabetology

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: August 10, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

DE (5)