TEEN-BEST
- Conditions
- Adolescents Roux-en-Y Gastric BypassSleeve Gastrectomy - Gastric SleeveSevere obesity
- Registration Number
- NL-OMON20900
- Lead Sponsor
- Department of General Surgery, Máxima Medical Center, De Run 4600, 5504 DB Veldhoven,The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
(i) Completed a minimum of twelve months in formal lifestyle intervention and/or pharmacotherapy weight loss program;
(ii) Age 13-17 with Tanner stage IV or more;
(iii) Severe obesity meeting IFSO criteria for bariatric surgery, BMI >40 kg/m2 with minor comorbidities or BMI >35 kg/m2 with at least one major comorbidity, corrected for age and sex according to the IOTF criteria;
(iv) Consensus in the multidisciplinary child obesity team, during the multidisciplinary meeting, on a strongly motivated participation of the participant during the lifestyle intervention program so far and in the future (after the bariatric surgery); the participant must have been fully committed to be successful in this program and is expected to continue with this effort after bariatric surgery;
(V) Consensus in the multidisciplinary child obesity team on the diagnosis of non-responding to multidisciplinary lifestyle interventions for now and the near future.
- Unable to consent as appropriate;
- Illiteracy (disability to read and understand questionnaires);
- Secondary obesity (obesity caused by a medical condition for example untreated hypothyroidism);
- Known syndrome or genetic disorder (such as Prader-Willi syndrome);
- Skeletal immaturity (Tanner stage < IV, pre-menarche, bone age < 15 years in boys);
- Ongoing addiction (alcohol, drugs, medication);
- Previous bariatric, gastro-esophageal reflux or gastric surgery;
- Uncontrolled psychiatric disorders;
- Inflammatory Bowel Disease (IBD);
- Non-support / non-consent of both parents / caretakers of adolescents aged 13-15 years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (i)Proportion of adolescents presented to the national board achieving 20% total weight loss (%TWL) 1 year after surgery;<br>(ii)Incidence of adverse health events and additional surgical intervention.
- Secondary Outcome Measures
Name Time Method (i)Number of appointments per discipline and follow-up attendance;<br>(ii)Patient satisfaction and satisfaction of the multidisciplinary team members;<br>(iii)Perceived organization of care by the multidisciplinary team members.<br><br><br>(iv)Change in body weight, change in body mass index (BMI), %TWL and change in BMI standard deviation score;<br>(v)Prevalence and remission of obesity-related comorbidities;<br>(vi)Prevalence of cardio metabolic health parameters;<br>(vii)Bone health measures and incidence of bone fractures;<br>(viii)Quality of life, psychosocial health measures, and educational attainment;<br>(ix)Body composition.