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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 April 2024 |
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Main ID: |
NCT00923819 |
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Date of registration:
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17/06/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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4XL Study - Obesity Surgery in Adolescence
4XL |
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Scientific title:
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4XL-Study - Obesity Surgery in Adolescence |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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120 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT00923819 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Norway
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Contacts
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Name:
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Jøran Hjelmesæth, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vestfold Hospital Trust/The Hospital of Vestfold |
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Name:
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Samira Lekhal, PhD,MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vestfold Hospital Trust/The Hospital of Vestfold |
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Key inclusion & exclusion criteria
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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
Age minimum:
13 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obesity, Morbid
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Intervention(s)
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Procedure: Laparoscopic gastric bypass
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Behavioral: Standard conservative treatment
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Primary Outcome(s)
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BMI and weight loss
[Time Frame: Baseline, Year 1, 2, 5, 10]
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Secondary Outcome(s)
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Mental Health (Development and Well-Being Assessment, DAWBA)
[Time Frame: 10 years]
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Blood sample results
[Time Frame: 10 years]
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Eating Disorders (Child Eating Behavior Questionnaire)
[Time Frame: 10 years]
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Self-Esteem (Rosenberg Self-Esteem scale)
[Time Frame: 10 years]
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Surgical and Medical Complications
[Time Frame: 10 years]
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Quality of Life (KINDL)
[Time Frame: 10 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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