An observational study in Obesity and Extreme Obesity, sponsored by Prof. Dr. Martin Wabitsch. Active, not recruiting at 5 sites in Germany. Open to participants aged 14 Years to 24 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Prof. Dr. Martin Wabitsch · Observational
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 66 is below the median of 135 across 1,283 observational studies indexed under Obesity.
Browse Obesity studies →Prof. Dr. Martin Wabitsch is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects will be recruited from a cohort of young adults and adolescents participating in the "Adolescents with extreme Obesity" Study.
Exclusion Criteria:
subjects who participate in the overall project and undergo bariatric surgery
Procedure: bariatric surgery
subjects who participate in the overall project and do not undergo bariatric surgery
Other: conservative care
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.
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.)
BMI change from baseline
Time frame: 1 year postoperative
BMI
Time frame: every 6 months for 9 years
changes in somatic comorbidity
Will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires.
Time frame: every 12 months for 9 years
changes in psychosocial comorbidity
Will be assessed via standardized patient questionnaires.
Time frame: every 12 months for 9 years
changes in psychiatric comorbidity
Will be assessed via standardized psychiatric evaluation and standardized and validated patient questionnaires.
Time frame: every 12 months for 9 years
peri- und postoperative complications
Will be assessed via physician questionnaires.
Time frame: every 12 months for 9 years
vitamin deficiencies
Will be assessed via patient questionnaire and laboratory studies.
Time frame: every 6 months for 9 years
adherence with postoperative recommendations on supplements, doctors visits and nutrition
Will be assessed via patient questionnaire.
Time frame: every 12 months for 9 years
hunger, food tolerance, gastrointestinal symptoms, dumping
Will be assessed via patient questionnaire.
Time frame: every 12 months for 9 years
eating behavior
Will be assessed via validated questionnaire (EDE-Q).
Time frame: every 12 months for 9 years
exercise
Will be assessed via validated questionnaire (IPAQ).
Time frame: every 12 months for 9 years
changes in quality of life: SF36
Will be assessed via validated questionnaires (SF36).
Time frame: every 12 months for 9 years
changes in quality of life: IWQOL
Will be assessed via validated questionnaires (IWQOL).
Time frame: every 12 months for 9 years
schooling, vocation, psychosocial situation, functional impairments
Will be assessed via standardized patient questionnaire.
Time frame: every 12 months for 9 years
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Prof. Dr. Martin Wabitsch