A randomized controlled trial comparing intensive non-surgical treatment with bariatric surgery in adolescents aged 13–16 years (AMOS2): Rationale, study design, and patient recruitment

• Published in: Contemporary clinical trials communications Vol. 19; p. 100592
• Main Authors: Janson, Annika, Järvholm, Kajsa, Gronowitz, Eva, Sjögren, Lovisa, Klaesson, Sven, Engström, My, Peltonen, Markku, Ekbom, Kerstin, Dahlgren, Jovanna, Olbers, Torsten
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01.09.2020; Elsevier
• Subjects: adolescent; Adolescents; Bariatric surgery; body mass; clinical article; clinical trial protocol; conservative treatment; controlled study; female; Gastroenterologi; Gastroenterology and Hepatology; human; intermethod comparison; Kirurgi; Low-calorie diet; male; Medicin och hälsovetenskap; morbid obesity; multicenter study; non insulin dependent diabetes mellitus; Obesity; Pediatric; priority journal; randomized controlled trial; Roux-en Y gastric Bypass; sex difference; Surgery; Sweden; Obesity; Bariatric surgery; BORIS; DXA; LCD; SOReg; Roux-en Y gastric Bypass; Low-calorie diet; AMOS2; GB; Adolescents; Pediatric; BMI; GB, Roux-en-Y Gastric Bypass; LCD, Low-Calorie Diet; BORIS, Swedish Childhood Obesity Treatment Register; DXA, Dual Energy X-Ray Absorptiometry; BMI, Body Mass Index; AMOS2, Adolescence Morbid Obesity Study 2; SOReg, Scandinavian Obesity Surgery Registry
• ISSN: 2451-8654; 2451-8654
• DOI: 10.1016/j.conctc.2020.100592

Previous non-randomized studies show similar outcomes in adolescents and adults after bariatric surgery. We describe the study protocol, recruitment, and selected baseline data of patients in a randomized multi-center study, the Adolescent Morbid Obesity Surgery 2 (AMOS2). Three clinics in Sweden collaborated in designing the study and recruitment of patients from August 1, 2014 to June 30, 2017. Patients were selected among adolescents 13–16 years of age attending third-level obesity care for at least one year. Patients were randomized 1:1 to bariatric surgery (predominantly Roux-en-Y gastric bypass) or intensive non-surgical treatment starting with an eight-week low-calorie-diet. Fifty adolescents (37 girls) were randomized, 25 (19 girls) to bariatric surgery. Mean age was 15.7 years (range 13.3–16.9), weight 122.6 kg (range 95–183.3), Body Mass Index (BMI) 42.6 kg/m2 (range 35.7–54.9) and BMI-SDS 3.45 (range 2.9–4.1). One patient had type 2 diabetes mellitus, and 12/45 (27%) had elevated liver enzymes. There were no significant differences between the groups. For the 39 eligible patients who were offered but declined inclusion, BMI was not different from included patients. However, patients who declined were younger, 15.2 years (p = 0.021). A sex difference was also noted with more of eligible girls, 37/53 (69.8%), than boys, 13/36 (36.1%), wanting to participate in the study (p = 0.002). This clinical trial, randomizing adolescents with severe obesity to bariatric surgery or intensive non-surgical treatment, aims at informing about whether it is beneficial to undergo bariatric surgery in early adolescence. It will also enlighten the outcome of comprehensive non-surgical treatment. The study was registered at www.clinicalTrials.gov number NCT02378259. •Bariatric surgery is already a treatment option for adolescents with severe obesity in many countries.•We recruited 50 patients 13-16 years of age to a randomized controlled trial.•We aimed at investigating the optimal time point for bariatric surgery.•Adolescents and their families seemed to make well considered decisions to participate in the study.