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Randomized Clinical Trial; Medical vs Bariatric Surgery for Adolescents (13-16 y) With Severe Obesity
Sponsor: Göteborg University
Summary
Severe childhood obesity is associated with both immediate and chronic health problems and a severe impact on psychosocial development. Medical and behavioural interventions rarely result in the significant, durable weight loss necessary to improve health outcomes. This is a randomised clinical trial where 50 adolescents, 13-16 years of age, will be randomised to either early bariatric surgery (Roux-en-Y gastric bypass) or intense conservative treatment and possibly surgery after two years of non-surgical treatment or as they have become 18 years.
Official title: AMOS2 (Adolescent Morbid Obesity Surgery)
Key Details
Gender
All
Age Range
13 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2014-08-15
Completion Date
2034-06
Last Updated
2022-03-25
Healthy Volunteers
No
Interventions
Laparoscopic Roux-en-Y gastric bypass
Bariatric surgery with Roux-en-Y gastric bypass as preferred option, possible laparoscopic Vertical Sleeve Gastrectomy
Intense conservative treatment
Intense medical treatment for obesity (behavioral treatment, dietary intervention, exercise, medication etc) 8 week period of Low Calorie Diet. Treatment intensity about 1 visit a month over 2 years
Locations (3)
Sahlgrenska University hospital
Gothenburg, Sweden
Skåne University Hospital
Malmo, Sweden
Karolinska University hospital
Stockholm, Sweden