Course of Obesity and Extreme Obesity in Adolescents

NCT ID: NCT01662271

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 429 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2023-07-31

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.

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 24.9 years (initial age up to 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. 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 annually (initially examinations were biannually, this was changed in an amendment in December 2014), 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.

Conditions

Obesity; Extreme Obesity

Study Design

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

Study Groups

adolescents with extreme obesity

BMI ≥35kg/m2

No interventions assigned to this group

adolescents with obesity

BMI 30-34.9kg/m2

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• 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

Helmholtz Zentrum München

INDUSTRY

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

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

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

U1111-1131-4384e

Identifier Type: -

Identifier Source: org_study_id