4XL Study - Obesity Surgery in Adolescence

4XL-Study - Obesity Surgery in Adolescence

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00923819

Acronym

4XL

Enrollment

120

Registered

2009-06-18

Start date

2009-06-01

Completion date

2035-12-01

Last updated

2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

Keywords

Adolescents, Gastric Bypass, Quality of Life, Mental Health, Lifestyle

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.

Interventions

PROCEDURELaparoscopic 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.

BEHAVIORALStandard conservative treatment

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
BMI and weight loss	Baseline, Year 1, 2, 5, 10	Surgical or standard conservative treatment

Secondary

Measure	Time frame	Description
Quality of Life (KINDL)	10 years	Web-based questionnaire baseline and after 1, 2, 5 and 10 years.
Eating Disorders (Child Eating Behavior Questionnaire)	10 years	Web-based questionnaire 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.
Self-Esteem (Rosenberg Self-Esteem scale)	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.
Blood sample results	10 years	Blood tests are biobanked at baseline and after 1, 2, 5 and 10 years.

Countries

Norway

Contacts

PRINCIPAL_INVESTIGATORSamira Lekhal, PhD,MD

Vestfold Hospital Trust/The Hospital of Vestfold

STUDY_CHAIRJøran Hjelmesæth, MD, PhD