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4XL Study - Obesity Surgery in Adolescence

This study is currently recruiting participants.
Verified April 2010 by Sykehuset i Vestfold HF
Sponsor:
Collaborators:
The Hospital of Vestfold
Oslo University Hospital Ulleval
University of Oslo
Information provided by:
Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier:
NCT00923819
First received: June 17, 2009
Last updated: April 22, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention
Obesity, Morbid
 Procedure: Laparoscopic gastric bypass
Behavioral: Standard conservative treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 4XL-Study - Obesity Surgery in Adolescence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sykehuset i Vestfold HF:

Primary Outcome Measures:
  • BMI [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: Year 2 ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: Year 5 ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: Year 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life (KINDL) [ Time Frame: Year ] [ Designated as safety issue: No ]
    Recorded at baseline and after 1, 2, 5 and 10 years.

  • Eating Disorders (Child Eating Behavior Questionnaire) [ Time Frame: Year ] [ Designated as safety issue: No ]
    Recorded at baseline and after 1, 2, 5 and 10 years.

  • Mental Health (Development and Well-Being Assessment, DAWBA) [ Time Frame: Year ] [ Designated as safety issue: No ]
    Recorded at baseline and after 1, 2, 5 and 10 years.

  • Self-Esteem (Rosenberg Self-Esteem scale) [ Time Frame: Year ] [ Designated as safety issue: No ]
    Recorded at baseline and after 1, 2, 5 and 10 years.

  • Surgical and Medical Complications [ Time Frame: Year ] [ Designated as safety issue: Yes ]
    Recorded at baseline and after 1, 2, 5 and 10 years.

  • Blood sample results [ Time Frame: Year ] [ Designated as safety issue: No ]
    Blood tests are biobanked at baseline and after 1, 2, 5 and 10 years.


Estimated Enrollment: 120
Study Start Date: June 2009
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Procedure: Laparoscopic gastric bypass
Patients are referred to Morbid Obesity Center from other hospitals in Norway. The procedure will take place at the Hospital of Vestfold.
Active Comparator: Group B Behavioral: Standard conservative treatment
The participants are included for 2 years follow-up with visits to a multidisciplinary team every 3rd month, either at the Morbid Obesity Center or a similar center in Norway.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923819

Contacts
Contact: Martin Handeland, MD +4748138808 martin.handeland@siv.no
Contact: Jøran Hjelmesæth, MD, PhD +4740217349 joran.hjelmeseth@siv.no

Locations
Norway
Morbid Obesity Center, The Hospital of Vestfold, South-Eastern Norway Regional Health Authority Recruiting
Tønsberg, Norway, 3103
Principal Investigator: Martin Handeland, MD            
Sponsors and Collaborators
Sykehuset i Vestfold HF
The Hospital of Vestfold
Oslo University Hospital Ulleval
University of Oslo
Investigators
Study Director: Martin Handeland, MD Vestfold Hospital Trust/The Hospital of Vestfold
Study Chair: Jøran Hjelmesæth, MD, PhD Vestfold Hospital Trust/The Hospital of Vestfold
  More Information

No publications provided

Responsible Party: Martin Handeland/MD, Morbid Obesity Center in South-Eastern Norway Regional Health Authority
ClinicalTrials.gov Identifier: NCT00923819     History of Changes
Other Study ID Numbers: 4XL-2009
Study First Received: June 17, 2009
Last Updated: April 22, 2010
Health Authority: Norway: Ministry of Health and Care Services

Keywords provided by Sykehuset i Vestfold HF:
Adolescents
Gastric Bypass
Quality of Life
Mental Health
Lifestyle

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013