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. 2020 Jun 27:19:100592.
doi: 10.1016/j.conctc.2020.100592. eCollection 2020 Sep.

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

Annika Janson  1   2 , Kajsa Järvholm  3   4 , Eva Gronowitz  4 , Lovisa Sjögren  4 , Sven Klaesson  5   6 , My Engström  7   8 , Markku Peltonen  9 , Kerstin Ekbom  2 , Jovanna Dahlgren  4 , Torsten Olbers  10   11
Affiliations

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

Annika Janson et al. Contemp Clin Trials Commun. .

Erratum in

Abstract

Background: 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).

Methods: 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.

Results: 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).

Conclusions: 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.

Keywords: AMOS2, Adolescence Morbid Obesity Study 2; Adolescents; BMI, Body Mass Index; BORIS, Swedish Childhood Obesity Treatment Register; Bariatric surgery; DXA, Dual Energy X-Ray Absorptiometry; GB, Roux-en-Y Gastric Bypass; LCD, Low-Calorie Diet; Low-calorie diet; Obesity; Pediatric; Roux-en Y gastric Bypass; SOReg, Scandinavian Obesity Surgery Registry.

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Figures

Fig. 1
Fig. 1
Consort schedule showing flow of patients in the study Adolescent Morbid Obesity Surgery 2.
See this image and copyright information in PMC

References

    1. Azzopardi P.S. Progress in adolescent health and wellbeing: tracking 12 headline indicators for 195 countries and territories, 1990-2016. Lancet. Mar. 2019;393(10176):1101–1118. doi: 10.1016/S0140-6736(18)32427-9. - DOI - PMC - PubMed
    1. Ng M. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet (London, England) Aug. 2014;384(9945):766–781. doi: 10.1016/s0140-6736(14)60460-8. - DOI - PMC - PubMed
    1. Simmonds M., Llewellyn A., Owen C.G., Woolacott N. Simple tests for the diagnosis of childhood obesity: a systematic review and meta-analysis. Obes. Rev. 2016;17(12):1301–1315. doi: 10.1111/obr.12462. - DOI - PubMed
    1. Twig G. Body-Mass index in 2.3 million adolescents and cardiovascular death in adulthood. N. Engl. J. Med. Apr. 2016 doi: 10.1056/NEJMoa1503840. - DOI - PubMed
    1. Llewellyn A., Simmonds M., Owen C.G., Woolacott N. Childhood obesity as a predictor of morbidity in adulthood: a systematic review and meta-analysis. Obes. Rev. Jan. 2016;17(1):56–67. doi: 10.1111/obr.12316. - DOI - PubMed

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