Identification and Characterization of Youth With Extreme Obesity

NCT01625325 | Completed DMC

• 3 other identifiers: U1111-1131-4384aDRKS0000417201GI1120A
• Study Type: observational
• Target: 429
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Obesity; Extreme Obesity

Keywords

obesity, adiposity, psychosocial, healthcare, co-morbidities, low key intervention, quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline

Secondary Outcomes (10)

• Predictors of the acceptance of the diagnostic procedures

  baseline

• Prevalence of obesity associated psychiatric co-morbidities

  baseline

• Percentage of patients that accept treatment of somatic co-morbidities

  baselin

• Predictors of acceptance of treatment of co-morbidities

  baseline

• Health related quality of life

  baseline

Study Arms (2)

extremely obese

BMI ≥35kg/m2

obese

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

You may not qualify if:

• none

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

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 (2)

• 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.

  PMID: 32138734 DERIVED

• 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

Condition Hierarchy (Ancestors)

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

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

• Anja Moss, Dr. biol. hum.

  University of Ulm

  STUDY DIRECTOR

• Belinda S Lennerz, Dr. med.

  University of Ulm

  STUDY DIRECTOR

• Julia von Schnurbein, Dr. med.

  University of Ulm

  STUDY DIRECTOR

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: June 19, 2012
• First Posted: June 21, 2012
• Study Start: July 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 13, 2018

Record last verified: 2018-06

Locations

DE (5)