4XL Study - Obesity Surgery in Adolescence
4XL
4XL-Study - Obesity Surgery in Adolescence
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 17, 2009
CompletedFirst Posted
Study publicly available on registry
June 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2035
April 24, 2026
March 1, 2026
24.2 years
June 17, 2009
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
BMI and weight loss
Surgical or standard conservative treatment
Baseline, Year 1, 2, 5, 10
Secondary Outcomes (6)
Quality of Life (KINDL)
10 years
Eating Disorders (Child Eating Behavior Questionnaire)
10 years
Mental Health (Development and Well-Being Assessment, DAWBA)
10 years
Self-Esteem (Rosenberg Self-Esteem scale)
10 years
Surgical and Medical Complications
10 years
- +1 more secondary outcomes
Study Arms (2)
Group A
EXPERIMENTALLaparoscopic Gastric Bypass
Group B
ACTIVE COMPARATORStandard conservative treatment. Patients from Child Obesity Registry of Vestfold.
Interventions
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.
Participants from Child Obesity Registry who undergoes conservative treatment at Morbid Obesity Center, Vestfold Hospital Trust.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sykehuset i Vestfold HFlead
- The Hospital of Vestfoldcollaborator
Study Sites (1)
Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority
Tønsberg, 3103, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, MD
Study Record Dates
First Submitted
June 17, 2009
First Posted
June 18, 2009
Study Start
June 1, 2009
Primary Completion (Estimated)
August 1, 2033
Study Completion (Estimated)
December 1, 2035
Last Updated
April 24, 2026
Record last verified: 2026-03