AMOS2 (Adolescent Morbid Obesity Surgery)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Body Mass Index (kg/m2)
研究概览
简要总结
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.
详细描述
A multicentre randomised clinical trial where three tertiary referral hospitals recruit patients.
Patients and their parents receive information about the study at their paediatric clinic and at the trial web page (www.amos2.se). Standardised procedure, including signed informed consent.
Interventions
At the end of day of baseline examination patients are randomised to either of two arms:
- Bariatric surgery with regular follow up
- Optimised conservative treatment starting with an 8-week Low Calorie Diet period followed by tailored support and treatment by the multidisciplinary team with an intensity of at least one visits a month over at least 2 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13-16 years
- •Failed comprehensive treatment for obesity > 1 year
- •Passing assessment of psychologist
- •Tanner 3 or more
排除标准
- •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
结局指标
主要结局
Body Mass Index (kg/m2)
时间窗: 2 years after treatment initiation
次要结局
- Socioeconomic development(5, 10 and 15 years after treatment initiation)
- Health care consumption(2, 5, 10 and 15 years after treatment initiation)
- Metabolic control(2, 5, 10 and 15 years after treatment initiation)
- Addictive behavior(2, 5, 10, 15 years after treatment initiation)
- Adverse events(2, 5, 10 and 15 years after treatment initiation)
- Cognitive Function(1, 2 and 5 years after treatment initiation)
- Working memory(1, 2 and 5 years after treatment initiation)
- Obesity-specific quality of life(2, 5, 10 and 15 years after treatment initiation)
- Mental health(2, 5, 10 and 15 years after treatment initiation)
- Energy expenditure(5 years after treatment initiation)
- Quality of life, generic(2, 5, 10 and 15 years after treatment initiation)
- Eating function(2, 5, 10 and 15 years after treatment initiation)
- Attention(1, 2 and 5 years after treatment initiation)
- Skeletal maturation and quality(2, 5, 10 and 15 years after treatment initiation)
- Body Mass Index, body weight, height. Additional assessments of primary outcome(5, 10 and 15 years after treatment initiation)