4XL Study - Obesity Surgery in Adolescence (4XL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00923819|
Recruitment Status : Recruiting
First Posted : June 18, 2009
Last Update Posted : June 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obesity, Morbid||Procedure: Laparoscopic gastric bypass Behavioral: Standard conservative treatment||Not Applicable|
The study has two intervention arms:
Experimental: Group A Surgery; laparoscopic gastric bypass
Active comparator: Group B Patients from Child Obesity Registry of Vestfold who get standard conservative treatment in a multidisiplinary team at Morbid Obesity Center.
All patients are referred to Morbid Obesity Center from other hospitals or general practionairs in Norway. The procedure will take place at the Vestfold Hospital Trust The participants are included for 2 years follow-up with visits to a multidisciplinary team every 3rd month at the Morbid Obesity Center. Total follow-up time is ten years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||4XL-Study - Obesity Surgery in Adolescence|
|Study Start Date :||June 2009|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2027|
Experimental: Group A
Laparoscopic Gastric Bypass
Procedure: Laparoscopic gastric bypass
Patients are referred to Morbid Obesity Center from other hospitals in Norway. The procedure will take place at the Hospital of Vestfold.
Active Comparator: Group B
Standard conservative treatment
Behavioral: Standard conservative treatment
The participants are included for 2 years follow-up with visits to a multidisciplinary team every 3rd month, either at the Morbid Obesity Center or a similar center in Norway.
- BMI [ Time Frame: Year 1, 2, 5, 10 ]
- Quality of Life (KINDL) [ Time Frame: Year ]Recorded at baseline and after 1, 2, 5 and 10 years.
- Eating Disorders (Child Eating Behavior Questionnaire) [ Time Frame: Year ]Recorded at baseline and after 1, 2, 5 and 10 years.
- Mental Health (Development and Well-Being Assessment, DAWBA) [ Time Frame: Year ]Recorded at baseline and after 1, 2, 5 and 10 years.
- Self-Esteem (Rosenberg Self-Esteem scale) [ Time Frame: Year ]Recorded at baseline and after 1, 2, 5 and 10 years.
- Surgical and Medical Complications [ Time Frame: Year ]Recorded at baseline and after 1, 2, 5 and 10 years.
- Blood sample results [ Time Frame: Year ]Blood tests are biobanked at baseline and after 1, 2, 5 and 10 years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923819
|Contact: Samira Lekhal, PhD,MDfirstname.lastname@example.org|
|Contact: Jøran Hjelmesæth, MD, PhDemail@example.com|
|Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority||Recruiting|
|Tønsberg, Norway, 3103|
|Principal Investigator: Samira Lekhal, MD, PhD|
|Principal Investigator:||Samira Lekhal, PhD,MD||Vestfold Hospital Trust/The Hospital of Vestfold|
|Study Chair:||Jøran Hjelmesæth, MD, PhD||Vestfold Hospital Trust/The Hospital of Vestfold|