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NCT Number: NCT00923819

4XL Study - Obesity Surgery in Adolescence

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity, Morbid Behavior Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority

Tønsberg, 3103, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic gastric bypass

Procedure

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.

Standard conservative treatment

Behavioral

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

Primary outcomes

  1. BMI and weight loss

    Time frame: Baseline, Year 1, 2, 5, 10

    Surgical or standard conservative treatment

Secondary outcomes

  1. Quality of Life (KINDL)

    Time frame: 10 years

    Web-based questionnaire baseline and after 1, 2, 5 and 10 years.

  2. Eating Disorders (Child Eating Behavior Questionnaire)

    Time frame: 10 years

    Web-based questionnaire baseline and after 1, 2, 5 and 10 years.

  3. Mental Health (Development and Well-Being Assessment, DAWBA)

    Time frame: 10 years

    Web-based questionnaire baseline and after 1, 2, 5 and 10 years.

  4. Self-Esteem (Rosenberg Self-Esteem scale)

    Time frame: 10 years

    Web-based questionnaire baseline and after 1, 2, 5 and 10 years.

  5. Surgical and Medical Complications

    Time frame: 10 years

    Web-based questionnaire baseline and after 1, 2, 5 and 10 years.

  6. Blood sample results

    Time frame: 10 years

    Blood tests are biobanked at baseline and after 1, 2, 5 and 10 years.

Sponsors and collaborators

Lead sponsor

Sykehuset i Vestfold HF

Other

Collaborators

  • The Hospital of Vestfold

Registry information

Official study title

4XL-Study - Obesity Surgery in Adolescence

Acronym: 4XL

Important dates

Study start
2009
Primary completion
2033
Study completion
2035
First posted
Jun 18, 2009
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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