Weight Loss Surgery in Adolescents With Extreme Obesity (YES)

May 18, 2022 updated by: Prof. Dr. Martin Wabitsch

Effectiveness and Safety of Weight Loss Surgery in Adolescents With Extreme Obesity Within a Structured Pre- and Post-surgery Treatment Program, Subproject 3

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.

Study Overview

Status

Active, not recruiting

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 13353
        • Ambulatory Obesity Program, Charité University, Berlin
      • Datteln, Germany
        • Vestische Kinderklinik, University of Witten/Herdecke
      • Essen, Germany, 45147
        • University Duisburg-Essen
      • Leipzig, Germany, 04103
        • University Hospital Leipzig
      • Ulm, Germany, 89075
        • Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be recruited from a cohort of young adults and adolescents participating in the "Adolescents with extreme Obesity" Study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
bariatric surgery group
subjects who participate in the overall project and undergo bariatric 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.
conservative care group
subjects who participate in the overall project and do not undergo bariatric surgery
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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BMI change from baseline
Time Frame: 1 year postoperative
1 year postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: every 6 months for 9 years
every 6 months for 9 years
changes in somatic comorbidity
Time Frame: every 12 months for 9 years
Will be assessed via standardized physical examination, laboratory and apparative tests, and standardized patient questionnaires.
every 12 months for 9 years
changes in psychosocial comorbidity
Time Frame: every 12 months for 9 years
Will be assessed via standardized patient questionnaires.
every 12 months for 9 years
changes in psychiatric comorbidity
Time Frame: every 12 months for 9 years
Will be assessed via standardized psychiatric evaluation and standardized and validated patient questionnaires.
every 12 months for 9 years
peri- und postoperative complications
Time Frame: every 12 months for 9 years
Will be assessed via physician questionnaires.
every 12 months for 9 years
vitamin deficiencies
Time Frame: every 6 months for 9 years
Will be assessed via patient questionnaire and laboratory studies.
every 6 months for 9 years
adherence with postoperative recommendations on supplements, doctors visits and nutrition
Time Frame: every 12 months for 9 years
Will be assessed via patient questionnaire.
every 12 months for 9 years
hunger, food tolerance, gastrointestinal symptoms, dumping
Time Frame: every 12 months for 9 years
Will be assessed via patient questionnaire.
every 12 months for 9 years
eating behavior
Time Frame: every 12 months for 9 years
Will be assessed via validated questionnaire (EDE-Q).
every 12 months for 9 years
exercise
Time Frame: every 12 months for 9 years
Will be assessed via validated questionnaire (IPAQ).
every 12 months for 9 years
changes in quality of life: SF36
Time Frame: every 12 months for 9 years
Will be assessed via validated questionnaires (SF36).
every 12 months for 9 years
changes in quality of life: IWQOL
Time Frame: every 12 months for 9 years
Will be assessed via validated questionnaires (IWQOL).
every 12 months for 9 years
schooling, vocation, psychosocial situation, functional impairments
Time Frame: every 12 months for 9 years
Will be assessed via standardized patient questionnaire.
every 12 months for 9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Martin Wabitsch, Prof. Dr. med., University of Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

April 1, 2018

Study Completion (Anticipated)

January 1, 2028

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • U1111-1131-4384c
  • DRKS00004172 (Registry Identifier: Deutsches Register Klinischer Studien)
  • 01GI1120A (Other Grant/Funding Number: Bundesministerium für Bildung und Forschung)
  • U1111-1131-8145 (OTHER: overall project: Medical & psychosoc. implications of adolescent extr. obesity, acceptance & effects of structured care)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on bariatric surgery

3
Subscribe