NCT01632098

Brief Summary

Obesity is one of the biggest public health challenges today and in the years to come, particularly due to its rising prevalence in children and adolescents. In addition to the increased health risks for each individual, obesity causes a tremendous economic burden on the healthcare system. Here, the investigators will examine the impact of extreme obesity on healthcare utilization, costs, and health related quality of life in adolescents. The 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. 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 complete questionnaires to assess health related quality of life and utilization of healthcare. These questionnaires will be applied at baseline and then every 12 months (initially every 6 months) during health check-ups. As part of the other subprojects of YES, participants will be invited to complete further questionnaires and will be offered a thorough medical examination, medical care and psycho-social support. The investigators expect to provide valid and up-to-date information on costs and health-related quality of life for obese adolescents. This information will help in the planning of useful and cost effective preventive and therapeutic strategies, and improve the medical care and support structures for obese adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
429

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

11 years

First QC Date

June 22, 2012

Last Update Submit

May 7, 2024

Conditions

Keywords

psychosocialhealthcareco-morbiditiesextremely obese adolescents

Outcome Measures

Primary Outcomes (1)

  • Economic burden of extreme obesity in adolescents living in Germany

    Resource utilization and calculate health care cost will be elicited using a standardized patient questionnaire that was developed and tested by the Helmholtz Zentrum München.

    baseline

Secondary Outcomes (3)

  • Health related quality of life associated with extreme obesity in adolescents

    at baseline and every 12 months

  • BMI

    at baseline and every 12 months

  • Changes in economic burden of extreme obesity in adolescents living in Germany

    every 12 months

Study Arms (2)

extremely obese

BMI ≥35kg/m2

obese

BMI 30-34.9kg/m2

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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.

Related Links

MeSH Terms

Conditions

ObesityObesity, Morbid

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Rolf Holle, Prof. Dr.

    Helmholz Center Munich

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 22, 2012

First Posted

June 29, 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