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
: June 5, 2017
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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 |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
---|---|
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.

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Ages Eligible for Study: | 13 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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,MD | +4741409191 | samira.lekhal@siv.no | |
Contact: Jøran Hjelmesæth, MD, PhD | +4740217349 | joran.hjelmeseth@siv.no |
Norway | |
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 |
Responsible Party: | Samira Lekhal, PhD, MD, Sykehuset i Vestfold HF |
ClinicalTrials.gov Identifier: | NCT00923819 History of Changes |
Other Study ID Numbers: |
4XL-2009 |
First Posted: | June 18, 2009 Key Record Dates |
Last Update Posted: | June 5, 2017 |
Last Verified: | May 2017 |
Keywords provided by Samira Lekhal, Sykehuset i Vestfold HF:
Adolescents Gastric Bypass Quality of Life Mental Health Lifestyle |
Additional relevant MeSH terms:
Obesity Obesity, Morbid Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |