4XL Study - Obesity Surgery in Adolescence

Not Applicable

Active, not recruiting

• Conditions: Obesity, Morbid
• Interventions: Procedure: Laparoscopic gastric bypass; Behavioral: Standard conservative treatment

• Registration Number: NCT00923819
• Lead Sponsor: Sykehuset i Vestfold HF

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2027-08
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Laparoscopic gastric bypass	Laparoscopic Gastric Bypass
Group B	Standard conservative treatment	Standard conservative treatment. Patients from Child Obesity Registry of Vestfold.

Primary Outcome Measures

Name	Time	Method
BMI and weight loss	Baseline, Year 1, 2, 5, 10	Surgical or standard conservative treatment

Secondary Outcome Measures

Name	Time	Method
Eating Disorders (Child Eating Behavior Questionnaire)	10 years	Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Quality of Life (KINDL)	10 years	Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Self-Esteem (Rosenberg Self-Esteem scale)	10 years	Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Blood sample results	10 years	Blood tests are biobanked at baseline and after 1, 2, 5 and 10 years.
Mental Health (Development and Well-Being Assessment, DAWBA)	10 years	Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Surgical and Medical Complications	10 years	Web-based questionnaire baseline and after 1, 2, 5 and 10 years.

Trial Locations

Locations (1)

Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority; 🇳🇴 Tønsberg, Norway