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NCT Number: NCT02062164

Weight Loss Surgery in Adolescents With Extreme Obesity

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity Body Weight Extreme Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ambulatory Obesity Program, Charité University, Berlin, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

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

Other

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.)

Primary outcomes

  1. BMI change from baseline

    Time frame: 1 year postoperative

Secondary outcomes

  1. BMI

    Time frame: every 6 months for 9 years

  2. 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.

  3. changes in psychosocial comorbidity

    Time frame: every 12 months for 9 years

    Will be assessed via standardized patient questionnaires.

  4. 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.

  5. peri- und postoperative complications

    Time frame: every 12 months for 9 years

    Will be assessed via physician questionnaires.

  6. vitamin deficiencies

    Time frame: every 6 months for 9 years

    Will be assessed via patient questionnaire and laboratory studies.

  7. adherence with postoperative recommendations on supplements, doctors visits and nutrition

    Time frame: every 12 months for 9 years

    Will be assessed via patient questionnaire.

  8. hunger, food tolerance, gastrointestinal symptoms, dumping

    Time frame: every 12 months for 9 years

    Will be assessed via patient questionnaire.

  9. eating behavior

    Time frame: every 12 months for 9 years

    Will be assessed via validated questionnaire (EDE-Q).

  10. exercise

    Time frame: every 12 months for 9 years

    Will be assessed via validated questionnaire (IPAQ).

  11. changes in quality of life: SF36

    Time frame: every 12 months for 9 years

    Will be assessed via validated questionnaires (SF36).

  12. changes in quality of life: IWQOL

    Time frame: every 12 months for 9 years

    Will be assessed via validated questionnaires (IWQOL).

  13. schooling, vocation, psychosocial situation, functional impairments

    Time frame: every 12 months for 9 years

    Will be assessed via standardized patient questionnaire.

Sponsors and collaborators

Lead sponsor

Prof. Dr. Martin Wabitsch

Other

Collaborators

  • Charite University, Berlin, Germany
  • University of Leipzig
  • University of Witten/Herdecke
  • Universität Duisburg-Essen

Registry information

Official study title

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

Acronym: YES

Important dates

Study start
2013
Primary completion
2018
Study completion
2028
First posted
Feb 13, 2014
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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