Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The BASIC Trial. Morbid Obesity in Children and Adolescents: a Prospective Randomised Trial of Conservative Treatment Versus Surgery
Brief Summary: Rationale:

In the Western world overweight and obesity is an increasing problem both in adults and in children. In youth, it is associated with early death and a number of co-morbidities including metabolic and endocrine changes, increased inflammatory status, cardiovascular abnormalities, nonalcoholic fatty liver disease, and impaired quality of life.

The standard treatment for morbid obesity in children is by combined life style interventions. However, the medium and long term effects of dietetic interventions, behaviour therapy and medication is relatively poor. In adults bariatric surgery shows good results with up to 30% weight reduction in 3 years. The preliminary results in youth are similar, but surgery in this age group is relatively uncommon. In the Netherlands surgery in this age group is only allowed in clinical trials, until the benefits and risks have been established. (National Health Authorities)

Objective:

To determine if surgery gives a superior weight and body mass index (BMI) reduction than combined life style interventions in adolescents with morbid obesity and to assess its effect on obesity associated co-morbidity.

Study design:

Prospective randomised interventional study.

Study population:

Morbidly obese children, aged 14 - 16 years, with sex and age adjusted BMI \>40 kg/m2 or \>35 kg/m2 with co-morbidity.

Intervention:

Bariatric surgery by laparoscopic adjustable gastric band (LAGB) or combined life style interventions

Main study parameters/endpoints:

Primary endpoints: weight loss, loss of excess weight, loss of excess BMI. Secondary endpoints: Body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, brain development, quality of life, and behaviour changes. The potential complications of surgery are monitored.


Options:
A: Arm Label: Laparoscopic adjustable gastric band; Type: EXPERIMENTAL; Interventions: Procedure: laparoscopic adjustable gastric band, Behavioral: Combined life style interventions | Arm Label: Control group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Combined life style interventions | Intervention Type: PROCEDURE; Name: laparoscopic adjustable gastric band; Assigned to Arm(s): Laparoscopic adjustable gastric band | Intervention Type: BEHAVIORAL; Name: Combined life style interventions; Assigned to Arm(s): Control group, Laparoscopic adjustable gastric band
B: N/A
C: Arm Label: gastric ring surgery; Type: EXPERIMENTAL; Interventions: Procedure: gastric ring surgery | Arm Label: nutritional help; Type: ACTIVE_COMPARATOR; Interventions: Other: nutritional help | Intervention Type: PROCEDURE; Name: gastric ring surgery; Assigned to Arm(s): gastric ring surgery | Intervention Type: OTHER; Name: nutritional help; Assigned to Arm(s): nutritional help
D: Arm Label: Medical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Advanced Medical Therapy and Bariatric Surgery | Arm Label: Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 Diabetes; Type: ACTIVE_COMPARATOR; Interventions: Drug: Advanced Medical Therapy | Arm Label: Bariatric Surgery in Youth with Obesity; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Bariatric Surgery | Intervention Type: PROCEDURE; Name: Advanced Medical Therapy and Bariatric Surgery; Assigned to Arm(s): Medical Therapy and Bariatric Surgery in Youth with Type 2 Diabetes | Intervention Type: DRUG; Name: Advanced Medical Therapy; Assigned to Arm(s): Medical Therapy in Youth with Type 2 Diabetesin Youth with Type 2 Diabetes | Intervention Type: PROCEDURE; Name: Bariatric Surgery; Assigned to Arm(s): Bariatric Surgery in Youth with Obesity

Answer: A