4XL Study - Obesity Surgery in Adolescence (4XL)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Obesity, Morbid	Procedure: Laparoscopic gastric bypass; Behavioral: Standard conservative treatment	Not Applicable

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	4XL-Study - Obesity Surgery in Adolescence
Study Start Date :	June 2009
Estimated Primary Completion Date :	December 2017
Estimated Study Completion Date :	December 2027

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Group A; Laparoscopic Gastric Bypass	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; Standard conservative treatment	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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. BMI [ Time Frame: Year 1, 2, 5, 10 ]

Secondary Outcome Measures :

1. Quality of Life (KINDL) [ Time Frame: Year ]
   Recorded at baseline and after 1, 2, 5 and 10 years.
2. Eating Disorders (Child Eating Behavior Questionnaire) [ Time Frame: Year ]
   Recorded at baseline and after 1, 2, 5 and 10 years.
3. Mental Health (Development and Well-Being Assessment, DAWBA) [ Time Frame: Year ]
   Recorded at baseline and after 1, 2, 5 and 10 years.
4. Self-Esteem (Rosenberg Self-Esteem scale) [ Time Frame: Year ]
   Recorded at baseline and after 1, 2, 5 and 10 years.
5. Surgical and Medical Complications [ Time Frame: Year ]
   Recorded at baseline and after 1, 2, 5 and 10 years.
6. Blood sample results [ Time Frame: Year ]
   Blood tests are biobanked at baseline and after 1, 2, 5 and 10 years.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	13 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Samira Lekhal, PhD,MD	+4741409191	samira.lekhal@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: Samira Lekhal, MD, PhD

Sponsors and Collaborators

Sykehuset i Vestfold HF

The Hospital of Vestfold

Investigators

Principal Investigator:	Samira Lekhal, PhD,MD	Vestfold Hospital Trust/The Hospital of Vestfold
Study Chair:	Jøran Hjelmesæth, MD, PhD	Vestfold Hospital Trust/The Hospital of Vestfold

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Samira Lekhal, PhD, MD, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier:	NCT00923819 History of Changes
Other Study ID Numbers:	4XL-2009
First Posted:	June 18, 2009
Last Update Posted:	June 5, 2017
Last Verified:	May 2017

Keywords provided by Samira Lekhal, 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