4XL Study - Obesity Surgery in Adolescence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study on adolescents between 13 and 18 years of age with morbid obesity is to determine whether surgical treatment gives more health benefits than standard conservative treatment, and if laparoscopic gastric bypass is a method with high safety and a low complication rate.

Detailed Description
-----------------
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.

Official Title
-----------------
4XL-Study - Obesity Surgery in Adolescence

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: Laparoscopic gastric bypass
* Behavioral: Standard conservative treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 13 and 18 years of age at inclusion Tanner stage 4-5 BMI > 40 kg/m2 or BMI > 35 with at least one comorbidity (type 2-diabetes, obstructive sleep apnea, serious hypertension or cerebral pseudotumor) At least one year multidisciplinary treatment completed Exclusion Criteria: Tanner stage < 4 Substantial risk for lack of compliance Obesity syndrome (e.g., Prader Willi syndrome) Obesity related to brain damage Serious general disease Monogenic obesity

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Laparoscopic Gastric Bypass | Procedure: Laparoscopic gastric bypass<br>* 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.<br>|
| Active Comparator: Group B<br>Standard conservative treatment. Patients from Child Obesity Registry of Vestfold. | Behavioral: Standard conservative treatment<br>* Participants from Child Obesity Registry who undergoes conservative treatment at Morbid Obesity Center, Vestfold Hospital Trust.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI and weight loss | Surgical or standard conservative treatment | Baseline, Year 1, 2, 5, 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (KINDL) | Web-based questionnaire baseline and after 1, 2, 5 and 10 years. | 10 years | 
| Eating Disorders (Child Eating Behavior Questionnaire) | Web-based questionnaire baseline and after 1, 2, 5 and 10 years. | 10 years | 
| Mental Health (Development and Well-Being Assessment, DAWBA) | Web-based questionnaire baseline and after 1, 2, 5 and 10 years. | 10 years | 
| Self-Esteem (Rosenberg Self-Esteem scale) | Web-based questionnaire baseline and after 1, 2, 5 and 10 years. | 10 years | 
| Surgical and Medical Complications | Web-based questionnaire baseline and after 1, 2, 5 and 10 years. | 10 years | 
| Blood sample results | Blood tests are biobanked at baseline and after 1, 2, 5 and 10 years. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescents, Gastric Bypass, Quality of Life, Mental Health, Lifestyle