4XL Study - Obesity Surgery in Adolescence

Obesity, Morbid Clinical Trial

— 4XL  

Official title:

4XL-Study - Obesity Surgery in Adolescence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00923819
• Other study ID #: 4XL-2009
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2009
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: Sykehuset i Vestfold HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Laparoscopic gastric bypass
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.

Behavioral:
• Standard conservative treatment
Participants from Child Obesity Registry who undergoes conservative treatment at Morbid Obesity Center, Vestfold Hospital Trust.

Locations

Country	Name	City	State
Norway	Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority	Tønsberg

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF	The Hospital of Vestfold

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI and weight loss	Surgical or standard conservative treatment	Baseline, Year 1, 2, 5, 10
Secondary	Quality of Life (KINDL)	Web-based questionnaire baseline and after 1, 2, 5 and 10 years.	10 years
Secondary	Eating Disorders (Child Eating Behavior Questionnaire)	Web-based questionnaire baseline and after 1, 2, 5 and 10 years.	10 years
Secondary	Mental Health (Development and Well-Being Assessment, DAWBA)	Web-based questionnaire baseline and after 1, 2, 5 and 10 years.	10 years
Secondary	Self-Esteem (Rosenberg Self-Esteem scale)	Web-based questionnaire baseline and after 1, 2, 5 and 10 years.	10 years
Secondary	Surgical and Medical Complications	Web-based questionnaire baseline and after 1, 2, 5 and 10 years.	10 years
Secondary	Blood sample results	Blood tests are biobanked at baseline and after 1, 2, 5 and 10 years.	10 years