Obesity, Extreme Obesity
Conditions
Keywords
psychosocial, healthcare, co-morbidities, extremely obese adolescents
Brief summary
The use of bariatric surgery in adolescents is controversial. On one side, bariatric surgery is the only effective treatment to achieve sustained weight loss in adults with extreme obesity. Comorbidities are reversed and mortality is reduced. In adolescents, bariatric surgery is equally effective; however, due to the paucity of long-term data, the long-term effects and risks are unknown. Thus, due to surgical risk and ethical implications, bariatric surgery is considered experimental in Germany. Nevertheless, case volumes are increasing. The aim of this study is to evaluate the benefits and risks of adolescent bariatric surgery in the context of a structured preparation and follow-up program. The study is a subproject of the study Medical and psychosocial implications of adolescent extreme obesity - acceptance and effects of structured care (DRKS00004172). At 5 German university centers (Ulm, Datteln, Berlin, Essen, Leipzig), youth who undergo bariatric surgery and are participants in the overall project will be enrolled in a structured preparation and follow-up program. The program is designed to improve adherence and compliance and will result in comprehensive follow-up data. In addition to the data gathered in the overall project, subjects participating in subproject 3 will undergo assessments pertinent to bariatric surgery, as proposed in the American Teen-LABS study (http://www.cincinnatichildrens.org/ research/divisions/t/teen-labs/default/). Comparison will be made with BMI matched adolescents who participate in the overall project but do not undergo bariatric surgery. In November 2014 recruitment for the overall project was completed. However, patients interested in bariatric surgery will still be recruited until September 2016. There assessment will be the same as for patients recruited earlier. However, in an amendment in December 2014, the frequency of assessment via questionnaire was reduced from biannually to annually. In addition, a travel reimbursement of 30€ for each study visit was implemented.
Interventions
PROCEDUREbariatric surgery
The intervention takes place in the clinical care setting. The decision for surgery is made by a multidisciplinary team, according to the international guidelines and the recommendations of the German working group on obesity (AGA, www.a.g.a.de). The choice of procedure is made on an individual basis taking into consideration patient inherent factors as well as the recommendations of the operating center. Operations are conducted at certified bariatric centers according to the policies of the German working group on bariatric surgery (CAADIP), and in the context of a structured preparation and follow-up program. The program is offered by a multidisciplinary team (pediatrician, endocrinologist, surgeon, dietician, psychologist/psychiatrist, social worker) and comprises preparation for and education about the surgery and expected lifestyle changes, as well as a structured, multidisciplinary follow-up plan. Subjects sign a contract agreeing to adhere to the recommended follow-up schedule.
OTHERconservative care
Subjects will be seen by a trained study physician every 6 months. Stuctured health assessments will be conducted, and individual treatment recommendations will be made based on the patients motivation and ability(e.g. inpatient obesity rehab, exercise, dietary or behavioral intervention etc.)
Sponsors
University of Witten/Herdecke
Charite University, Berlin, Germany
University of Leipzig
Universität Duisburg-Essen
Prof. Dr. Martin Wabitsch
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* BMI ≥ 35 kg/m2 with severe comorbidity or BMI ≥ 40 kg/m2 with relevant comorbidity * completed longitudinal growth * stable social surroundings * exhaustion of conservative treatment * participation in the project Adolescents with extreme Obesity * adequate compliance and adherence
Exclusion criteria
* treatable causative condition * unstable medical, psychosocial or psychiatric comorbidity * alcohol or drug abuse * pregnancy * contraindication for bariatric surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMI change from baseline | 1 year postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adherence with postoperative recommendations on supplements, doctors visits and nutrition | every 12 months for 9 years | Will be assessed via patient questionnaire. |
| hunger, food tolerance, gastrointestinal symptoms, dumping | every 12 months for 9 years | Will be assessed via patient questionnaire. |
| BMI | every 6 months for 9 years | — |
| changes in somatic comorbidity | every 12 months for 9 years | Will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires. |
| changes in psychosocial comorbidity | every 12 months for 9 years | Will be assessed via standardized patient questionnaires. |
| changes in psychiatric comorbidity | every 12 months for 9 years | Will be assessed via standardized psychiatric evaluation and standardized and validated patient questionnaires. |
| vitamin deficiencies | every 6 months for 9 years | Will be assessed via patient questionnaire and laboratory studies. |
| eating behavior | every 12 months for 9 years | Will be assessed via validated questionnaire (EDE-Q). |
| exercise | every 12 months for 9 years | Will be assessed via validated questionnaire (IPAQ). |
| changes in quality of life: SF36 | every 12 months for 9 years | Will be assessed via validated questionnaires (SF36). |
| changes in quality of life: IWQOL | every 12 months for 9 years | Will be assessed via validated questionnaires (IWQOL). |
| schooling, vocation, psychosocial situation, functional impairments | every 12 months for 9 years | Will be assessed via standardized patient questionnaire. |
| peri- und postoperative complications | every 12 months for 9 years | Will be assessed via physician questionnaires. |
Countries
Germany
Outcome results
None listed