The BASIC Trial. Morbid Obesity in Children and Adolescents: a Prospective Randomised Trial of Conservative Treatment Versus Surgery
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Weight
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 14 to 16
- •Age and sex adjusted BMI >40 kg/m2 or >35 kg/m2 with associated co-morbidity.
- •* Associated co-morbidity includes: glucose intolerance, type 2 diabetes, hypertension, pseudotumor cerebri, acanthosis nigricans, obstructive sleep apnoea syndrome, depression, arthropathies, non-alcoholic steatohepatitis and dyslipidemia.
- •> 1 year multidisciplinary organized weight reducing attempts with less than 5% weight loss
- •Demonstrate decisional capacity
Exclusion Criteria
- •Psychologically not suitable
- •Pre-menarche or bone age <15 years in boys
- •Obesity associated to other disorders such as hypothyroidism
- •Syndromal disorders such as Prader-Willi syndrome
- •Severe cardiorespiratory impairment (ASA class 3 or higher)
- •Insufficiently fluid in the Dutch language
- •Unwillingness to adhere to follow-up programmes
Arms & Interventions
Laparoscopic adjustable gastric band
Intervention: laparoscopic adjustable gastric band (Procedure)
Laparoscopic adjustable gastric band
Intervention: Combined life style interventions (Behavioral)
Control group
Intervention: Combined life style interventions (Behavioral)
Outcomes
Primary Outcomes
Weight
Time Frame: 36 months
Weight loss, excess weight loss and loss of excess BMI.
Weight
Time Frame: 6 months
Weight loss, excess weight loss and loss of excess BMI.
Weight
Time Frame: 12 months
Weight loss, excess weight loss and loss of excess BMI.
Weight
Time Frame: 24 months
Weight loss, excess weight loss and loss of excess BMI.
Secondary Outcomes
- Non-alcoholic fatty liver disease(36 months)
- Body composition(36 months)
- Metabolic and endocrine changes(36 months)
- Quality of life changes(36 months)
- Behaviour changes(36 months)
- Behavior towards food(36 months)
- Effects on sleep architecture(36 months)
- Pubertal development(36 months)
- Inflammatory status(36 months)
- Cardiovascular abnormalities(36 months)
- Operative complications(up to 36 months)
- Brain development(36 months)
- Physical activity(36 months)
- Quality of life changes(6 months)
- Metabolic and endocrine changes(12 months)
- Metabolic and endocrine changes(24 months)
- Quality of life changes(12 months)
- Quality of life changes(24 months)
- Effects on sleep architecture(12 months)
- Effects on sleep architecture(24 months)
- Body composition(12 months)
- Pubertal development(6 months)
- Metabolic and endocrine changes(6 months)
- Inflammatory status(6 months)
- Cardiovascular abnormalities(6 months)
- Non-alcoholic fatty liver disease(6 months)
- Behaviour changes(6 months)
- Effects on sleep architecture(6 months)
- Brain development(6 months)
- Body composition(24 months)
- Pubertal development(12 months)
- Pubertal development(24 months)
- Inflammatory status(12 months)
- Inflammatory status(24 months)
- Cardiovascular abnormalities(12 months)
- Cardiovascular abnormalities(24 months)
- Non-alcoholic fatty liver disease(12 months)
- Non-alcoholic fatty liver disease(24 months)
- Behaviour changes(12 months)
- Behaviour changes(24 months)
- Brain development(12 months)
- Brain development(24 months)
- Physical activity(6 months)
- Physical activity(12 months)
- Physical activity(24)
- Behavior towards food(6 months)
- Behavior towards food(12 months)
- Behavior towards food(24 months)