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| Name | Class |
|---|---|
| The Hospital of Vestfold | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Laparoscopic Gastric Bypass |
|
| Group B | Active Comparator | Standard conservative treatment. Patients from Child Obesity Registry of Vestfold. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic gastric bypass | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| BMI and weight loss | Surgical or standard conservative treatment | Baseline, Year 1, 2, 5, 10 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samira Lekhal, PhD,MD | Vestfold Hospital Trust/The Hospital of Vestfold | Principal Investigator |
| Jøran Hjelmesæth, MD, PhD | Vestfold Hospital Trust/The Hospital of Vestfold | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority | Tønsberg | 3103 | Norway |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Standard conservative treatment | Behavioral | Participants from Child Obesity Registry who undergoes conservative treatment at Morbid Obesity Center, Vestfold Hospital Trust. |
|
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |