Identification and Characterization of Youth With Extreme Obesity

NCT ID: NCT01625325

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 429 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-12-31

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.

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 24.9 years (initial age 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. 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 (in the amendment in February 2013, the scope of psychosocial questions was reduced), 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.

Conditions

Obesity; Extreme Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

extremely obese

BMI ≥35kg/m2

No interventions assigned to this group

obese

BMI 30-34.9kg/m2

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Witten/Herdecke

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role: collaborator

Prof. Dr. Martin Wabitsch

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Martin Wabitsch

Division Chief Pediatric Endocrinology and Diabetology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Martin Wabitsch, Prof. Dr. med.

Role: STUDY_CHAIR

University of Ulm

Susanna Wiegand, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Thomas Reinehr, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Witten/Herdecke

Johannes Hebebrand, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universität Duisburg-Essen

Wieland Kiess, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Reinhard Holl, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Anja Moss, Dr. biol. hum.

Role: STUDY_DIRECTOR

University of Ulm

Belinda S Lennerz, Dr. med.

Role: STUDY_DIRECTOR

University of Ulm

Julia von Schnurbein, Dr. med.

Role: STUDY_DIRECTOR

University of Ulm

Locations

Ambulatory Obesity Program, Charité University, Berlin

Berlin, , Germany

Vestische Kinderklinik, University of Witten/Herdecke

Datteln, , Germany

University Duisburg-Essen

Essen, , Germany

University Hospital Leipzig

Leipzig, , Germany

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

Ulm, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 32138734 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23987123 (View on PubMed)

Related Links

http://www.adipositasforschung-ulm.de/index.php?id=69

study homepage

Other Identifiers

DRKS00004172

Identifier Type: REGISTRY

Identifier Source: secondary_id

01GI1120A

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

U1111-1131-4384a

Identifier Type: -

Identifier Source: org_study_id