Back to results4XL Study - Obesity Surgery in Adolescence (4XL)
Primary Purpose
Obesity, Morbid
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Laparoscopic gastric bypass
Standard conservative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring Adolescents, Gastric Bypass, Quality of Life, Mental Health, Lifestyle
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
Sites / Locations
- Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Laparoscopic Gastric Bypass
Standard conservative treatment. Patients from Child Obesity Registry of Vestfold.
Outcomes
Primary Outcome Measures
BMI and weight loss
Surgical or standard conservative treatment
Secondary Outcome Measures
Quality of Life (KINDL)
Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Eating Disorders (Child Eating Behavior Questionnaire)
Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Mental Health (Development and Well-Being Assessment, DAWBA)
Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Self-Esteem (Rosenberg Self-Esteem scale)
Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Surgical and Medical Complications
Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Blood sample results
Blood tests are biobanked at baseline and after 1, 2, 5 and 10 years.
Full Information
NCT ID
NCT00923819
First Posted
June 17, 2009
Last Updated
August 8, 2023
Sponsor
Sykehuset i Vestfold HF
Collaborators
The Hospital of Vestfold
1. Study Identification
Unique Protocol Identification Number
NCT00923819
Brief Title
4XL Study - Obesity Surgery in Adolescence
Acronym
4XL
Official Title
4XL-Study - Obesity Surgery in Adolescence
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2009 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset i Vestfold HF
Collaborators
The Hospital of Vestfold
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
Adolescents, Gastric Bypass, Quality of Life, Mental Health, Lifestyle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Laparoscopic Gastric Bypass
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Standard conservative treatment. Patients from Child Obesity Registry of Vestfold.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic gastric bypass
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard conservative treatment
Intervention Description
Participants from Child Obesity Registry who undergoes conservative treatment at Morbid Obesity Center, Vestfold Hospital Trust.
Primary Outcome Measure Information:
Title
BMI and weight loss
Description
Surgical or standard conservative treatment
Time Frame
Baseline, Year 1, 2, 5, 10
Secondary Outcome Measure Information:
Title
Quality of Life (KINDL)
Description
Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Time Frame
10 years
Title
Eating Disorders (Child Eating Behavior Questionnaire)
Description
Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Time Frame
10 years
Title
Mental Health (Development and Well-Being Assessment, DAWBA)
Description
Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Time Frame
10 years
Title
Self-Esteem (Rosenberg Self-Esteem scale)
Description
Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Time Frame
10 years
Title
Surgical and Medical Complications
Description
Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Time Frame
10 years
Title
Blood sample results
Description
Blood tests are biobanked at baseline and after 1, 2, 5 and 10 years.
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samira Lekhal, PhD,MD
Organizational Affiliation
Vestfold Hospital Trust/The Hospital of Vestfold
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jøran Hjelmesæth, MD, PhD
Organizational Affiliation
Vestfold Hospital Trust/The Hospital of Vestfold
Official's Role
Study Chair
Facility Information:
Facility Name
Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority
City
Tønsberg
ZIP/Postal Code
3103
Country
Norway
12. IPD Sharing Statement
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4XL Study - Obesity Surgery in Adolescence
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