NCT02378259Active, not recruiting
Randomized Clinical Trial; Medical vs Bariatric Surgery for Adolescents (13-16 y) With Severe Obesity
AMOS2 (Adolescent Morbid Obesity Surgery)
Source: ClinicalTrials.gov · Last updated 25 Mar 2022
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 26 Aug 2014
- Start date
- 15 Aug 2014
- Primary completion date
- Jun 2022
- Lead sponsor
- Göteborg University
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT02378259
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 15 Aug 2014 to the primary completion date, Jun 2022
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous major gastrointestinal surgery
Other illness
- Psychotic or other major psychiatric illness
Other
- Monogenic obesity (for example Prader Willis, Laurence Moon-Bardet-Biedl)
- Obesity secondary to brain injury
- Severely mentally disabled
- Not eligible for general anesthesia
Who the study is looking for
- Age 13-16 years
- BMI \>35
- Failed comprehensive treatment for obesity \> 1 year
- Passing assessment of psychologist
- Tanner 3 or more
Age in the registry: 13 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Unknown status |
| Skåne University Hospital Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.