Economic Aspects of Extreme Obesity in Adolescent (YES)
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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 |
- 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.
- 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:
- 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.
- 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.
- 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.
- 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 |
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.
Inclusion Criteria:
- BMI ≥30kg/m2
- sufficient German language skills
Exclusion Criteria:
- none
Contacts and Locations| 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 |
| 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: Anke Schaefer | |
| Sub-Investigator: Barbara Wolters, D. med. | |
| Sub-Investigator: Alex Geisel | |
| University Duisburg-Essen | Recruiting |
| Essen, Germany, 45147 | |
| Contact: Johannes Hebebrand, Prof. Dr.med. +49 201 8707 466 johannes.hebebrand@uni-due.de | |
| Principal Investigator: Johannes Hebebrand, Prof. Dr.med. | |
| Sub-Investigator: André Scherag, Dr. rer. physiol. | |
| Sub-Investigator: Claudia Ose | |
| Sub-Investigator: Ulrike Caspar, Dipl. Psych. | |
| University Hospital Leipzig | Recruiting |
| Leipzig, Germany, 04103 | |
| Contact: Annett Witzmann +49 341 9726000 Annett.Witzmann@medizin.uni-leipzig.de | |
| Principal Investigator: Wieland Kiess, Prof. Dr. med. | |
| Sub-Investigator: Annett Witzmann | |
| 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. | |
| 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
| 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: | June 28, 2012 |
| 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 Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013