Randomized Clinical Trial; Medical vs Bariatric Surgery for Adolescents (13-16 y) With Severe Obesity
AMOS2
AMOS2 (Adolescent Morbid Obesity Surgery)
1 other identifier
interventional
50
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Aug 2014
Longer than P75 for not_applicable obesity
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2014
CompletedFirst Submitted
Initial submission to the registry
August 26, 2014
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2034
ExpectedMarch 25, 2022
March 1, 2022
7.8 years
August 26, 2014
March 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Body Mass Index (kg/m2)
2 years after treatment initiation
Secondary Outcomes (15)
Metabolic control
2, 5, 10 and 15 years after treatment initiation
Quality of life, generic
2, 5, 10 and 15 years after treatment initiation
Obesity-specific quality of life
2, 5, 10 and 15 years after treatment initiation
Socioeconomic development
5, 10 and 15 years after treatment initiation
Health care consumption
2, 5, 10 and 15 years after treatment initiation
- +10 more secondary outcomes
Other Outcomes (1)
Cancer or precancerous lesions
15 years after treatment initiation and later
Study Arms (2)
Bariatric surgery
EXPERIMENTALRoux-en-Y gastric bypass surgery
Intense conservative treatment
ACTIVE COMPARATORIntense conservative treatment. 8 week LCD followed by outpatient visits 1/ month
Interventions
Bariatric surgery with Roux-en-Y gastric bypass as preferred option, possible laparoscopic Vertical Sleeve Gastrectomy
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
Eligibility Criteria
You may qualify if:
- Age 13-16 years
- BMI \>35
- Failed comprehensive treatment for obesity \> 1 year
- Passing assessment of psychologist
- Tanner 3 or more
You may not qualify if:
- Monogenic obesity (for example Prader Willis, Laurence Moon-Bardet-Biedl)
- Obesity secondary to brain injury
- Severely mentally disabled
- Not eligible for general anesthesia
- Psychotic or other major psychiatric illness
- Previous major gastrointestinal surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Göteborg Universitylead
- Sahlgrenska University Hospitalcollaborator
- Karolinska University Hospitalcollaborator
- Lund Universitycollaborator
Study Sites (3)
Sahlgrenska University hospital
Gothenburg, 41345, Sweden
Skåne University Hospital
Malmo, Sweden
Karolinska University hospital
Stockholm, Sweden
Related Publications (3)
Jarvholm K, Gronowitz E, Janson A, Peltonen M, Sjogren L, Beamish AJ, Dahlgren J, Martensson J, Olbers T. Cognitive functioning in adolescents with severe obesity undergoing bariatric surgery or intensive non-surgical treatment in Sweden (AMOS2): a multicentre, open-label, randomised controlled trial. EClinicalMedicine. 2024 Feb 27;70:102505. doi: 10.1016/j.eclinm.2024.102505. eCollection 2024 Apr.
PMID: 38685922DERIVEDJarvholm K, Janson A, Peltonen M, Neovius M, Gronowitz E, Engstrom M, Laurenius A, Beamish AJ, Dahlgren J, Sjogren L, Olbers T. Metabolic and bariatric surgery versus intensive non-surgical treatment for adolescents with severe obesity (AMOS2): a multicentre, randomised, controlled trial in Sweden. Lancet Child Adolesc Health. 2023 Apr;7(4):249-260. doi: 10.1016/S2352-4642(22)00373-X. Epub 2023 Feb 24.
PMID: 36848922DERIVEDJanson A, Jarvholm K, Gronowitz E, Sjogren L, Klaesson S, Engstrom M, Peltonen M, Ekbom K, Dahlgren J, Olbers T. A randomized controlled trial comparing intensive non-surgical treatment with bariatric surgery in adolescents aged 13-16 years (AMOS2): Rationale, study design, and patient recruitment. Contemp Clin Trials Commun. 2020 Jun 27;19:100592. doi: 10.1016/j.conctc.2020.100592. eCollection 2020 Sep.
PMID: 32637723DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Torsten Olbers, MD, PhD
University of Gothenburg, Dept of Surgical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2014
First Posted
March 4, 2015
Study Start
August 15, 2014
Primary Completion
June 1, 2022
Study Completion (Estimated)
June 1, 2034
Last Updated
March 25, 2022
Record last verified: 2022-03