4XL Study - Obesity Surgery in Adolescence (4XL)
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|ClinicalTrials.gov Identifier: NCT00923819|
Recruitment Status : Recruiting
First Posted : June 18, 2009
Last Update Posted : April 30, 2018
|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 2020|
|Estimated Study Completion Date :||December 2027|
Experimental: Group A
Laparoscopic Gastric Bypass
Procedure: Laparoscopic gastric bypass
Patients are referred to Morbid Obesity Center from Vestfold Hospital Trust and other hospitals in Norway. The procedure will take place at Morbid Obesity Center, Vestfold Hospital Trust.
Active Comparator: Group B
Standard conservative treatment. Patients from Child Obesity Registry of Vestfold.
Behavioral: Standard conservative treatment
Participants from Child Obesity Registry who undergoes conservative treatment at Morbid Obesity Center, Vestfold Hospital Trust.
- BMI and weight loss [ Time Frame: Baseline, Year 1, 2, 5, 10 ]Surgical or standard conservative treatment
- Quality of Life (KINDL) [ Time Frame: 10 years ]Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
- Eating Disorders (Child Eating Behavior Questionnaire) [ Time Frame: 10 years ]Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
- Mental Health (Development and Well-Being Assessment, DAWBA) [ Time Frame: 10 years ]Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
- Self-Esteem (Rosenberg Self-Esteem scale) [ Time Frame: 10 years ]Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
- Surgical and Medical Complications [ Time Frame: 10 years ]Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
- Blood sample results [ Time Frame: 10 years ]Blood tests are biobanked at baseline and after 1, 2, 5 and 10 years.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923819
|Contact: Samira Lekhal, PhD,MDemail@example.com|
|Contact: Jøran Hjelmesæth, MD, PhDfirstname.lastname@example.org|
|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|