Economic Aspects of Extreme Obesity in Adolescent (YES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Ulm
Sponsor:
Collaborators:
University of Witten/Herdecke
Charite University, Berlin, Germany
University of Leipzig
Universität Duisburg-Essen
Helmholtz Zentrum München
Information provided by (Responsible Party):
Prof. Dr. Martin Wabitsch, University of Ulm
ClinicalTrials.gov Identifier:
NCT01632098
First received: June 22, 2012
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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 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 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.


Condition
Obesity
Extreme Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Medical and Psychosocial Implications of Adolescent Extreme Obesity - Acceptance and Effects of Structured Care Study, Subproject 4

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Economic burden of extreme obesity in adolescents living in Germany [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Health related quality of life associated with extreme obesity in adolescents [ Time Frame: at baseline, 6, 12, 18, 24, 30, and 36 months ] [ Designated as safety issue: Yes ]
    Health related quality of life will be elicited via validated patient questionnairs (EQ5D, DISABKIDS).

  • BMI [ Time Frame: at baseline, 6, 12, 18, 24, 30, and 36 months ] [ Designated as safety issue: No ]
    weight in kg divided by height squared in meters

  • Changes in economic burden of extreme obesity in adolescents living in Germany [ Time Frame: at 6, 12, 18, 24, 30, and 36 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1200
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
extremely obese
BMI ≥35kg/m2
obese
BMI 30-34.9kg/m2

Detailed Description:

Obesity is acknowledged as 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 physical, mental and social health consequences of the obesity epidemic, a major concern that emanates from overweight and obesity is the related economic burden. Here, the investigators will invexamine the impact of extreme obesity (BMI ≥35kg/m2) on healthcare utilization, costs, and health related quality of life in a cohort of adolescents. Adolescents with more moderate obesity (BMI 30-34.9kg/m2)will serve as a control group. 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 comprises the recruitment and characterization of obese (BMI 30-34.9kg/m2) and extremely obese (BMI ≥35kg/m2) 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 a long-term prospective observation study.

Based on the current state of knowledge, the investigators have formulated the following hypotheses in regards to healthcare utilization, costs, and health related quality of life:

  1. Cost induced by utilization of healthcare services of adolescents with extreme obesity (BMI ≥ 35kg/m2) will be significantly higher compared to cost induced by adolescents with obese (BMI 30-34.9kg/m2). In adolescents who undergo bariatric surgery, cost will decrease after the intervention.
  2. Adolescents with extreme obesity (BMI ≥ 35) have significantly lower health related quality of life compared to adolescents with obesity (BMI 30-34.9kg/m2). After specific interventions (psycho-social intervention in subproject 2, bariatric surgery in subproject 3), health related quality of life will increase after the intervention.
  3. The cost of the surgical intervention will be accompanied by strong positive effects (such as relative weight loss and health related quality of life) Therefore bariatric surgery will be cost-effective.
  4. The high costs of bariatric surgery will be amortized by health savings due to decreased utilization of health care services and lower indirect costs in the medium to long term.

A total of 600 adolescents age 14 to 21 years with extreme obesity (BMI ≥ 35 kg/m2) and 600 adolescents with obesity (BMI 30-34.9 kg/m2) will be recruited 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.

Utilization and healthcare costs associated with extreme obesity in adolescents will be assessed via standardized patient questionnaires. Health related quality of life associated with extreme obesity in adolescents will be assessed with validated instruments at baseline and then every 6 months. Cost-effectiveness and cost-utility analyses will be performed.

The investigators expect to provide valid and up-to-date information on healthcare costs and health-related quality of life for this relevant patient group. This information will inform the planning of future preventive and therapeutic strategies.

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632098

Contacts
Contact: Anja Moss, Dr. biol. hum. +49 7031 500 57401 ja-studie@uni-ulm.de
Contact: Belinda S Lennerz, Dr. med. +49 7031 500 57401 ja-studie@uni-ulm.de

Locations
Germany
Ambulatory Obesity Program, Charité University, Berlin Recruiting
Berlin, Germany, 13353
Contact: Annika Bickenbach, Dr.med.    +49 30 450 566 889    babeluga@charite.de   
Principal Investigator: Susanna Wiegand, Dr. med.         
Sub-Investigator: Annika Bickenbach, Dr. med.         
Vestische Kinderklinik, University of Witten/Herdecke Recruiting
Datteln, Germany
Contact: Anke Schaefer    +49 2363 975 349    A.Schaefer@kinderklinik-datteln.de   
Principal Investigator: Thomas Reinehr, Prof. Dr. med.         
Sub-Investigator: Barbara Wolters, D. med.         
University Duisburg-Essen Recruiting
Essen, Germany, 45147
Contact: Johannes Hebebrand, Prof. Dr.med.    +49 201 8707 466    ja-studie@uni-due.de   
Principal Investigator: Johannes Hebebrand, Prof. Dr.med.         
Sub-Investigator: André Scherag, Dr. rer. physiol.         
Sub-Investigator: Claudia Ose         
Sub-Investigator: Yvonne Mühlig, Dipl. Psych.         
University Hospital Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Madlen Neef    +49 341 9726000    Madlen.Neef@medizin.uni-leipzig.de   
Principal Investigator: Wieland Kiess, Prof. Dr. med.         
Sub-Investigator: Madlen Neef         
Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic Recruiting
Ulm, Germany, 89075
Contact: Anja S Moss, Dr. biol. hum.    +49 7031 500 57401    ja-studie@uni-ulm.de   
Contact: Belinda Lennerz, Dr. med.    +49 7031 500 57401    ja-studie@uni-ulm.de   
Principal Investigator: Martin Wabitsch, Prof. Dr. med.         
Sub-Investigator: Belinda S Lennerz, Dr. med.         
Sub-Investigator: Anja Moss, Dr. hum. biol.         
Sponsors and Collaborators
University of Ulm
University of Witten/Herdecke
Charite University, Berlin, Germany
University of Leipzig
Universität Duisburg-Essen
Helmholtz Zentrum München
Investigators
Principal Investigator: 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
Study Chair: Rolf Holle, Prof. Dr. Helmholz Center Munich
  More Information

Additional Information:
No publications provided by University of Ulm

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Martin Wabitsch, Division Chief Pediatric Endocrinology and Diabetology, University of Ulm
ClinicalTrials.gov Identifier: NCT01632098     History of Changes
Other Study ID Numbers: U1111-1131-4384d, DRKS00004197, 01GI1127, U1111-1131-8145
Study First Received: June 22, 2012
Last Updated: October 22, 2013
Health Authority: Germany: Federal Ministry of Education and Research
Germany: Ethics Commission

Keywords provided by University of Ulm:
psychosocial
healthcare
co-morbidities
extremely obese adolescents

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014