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
(2020) In Contemporary Clinical Trials Communications 19.- 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... (More)
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.
(Less)
- author
- Janson, Annika ; Järvholm, Kajsa LU ; Gronowitz, Eva ; Sjögren, Lovisa ; Klaesson, Sven ; Engström, My ; Peltonen, Markku ; Ekbom, Kerstin ; Dahlgren, Jovanna and Olbers, Torsten
- publishing date
- 2020-09
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Adolescents, Bariatric surgery, Low-calorie diet, Obesity, Pediatric, Roux-en Y gastric Bypass
- in
- Contemporary Clinical Trials Communications
- volume
- 19
- article number
- 100592
- publisher
- Elsevier
- external identifiers
-
- scopus:85087126309
- ISSN
- 2451-8654
- DOI
- 10.1016/j.conctc.2020.100592
- language
- English
- LU publication?
- no
- additional info
- Publisher Copyright: © 2020
- id
- 28d5f53a-3cce-46c7-a977-eadc7616c8a1
- date added to LUP
- 2024-10-23 06:29:04
- date last changed
- 2025-04-04 15:03:19
@article{28d5f53a-3cce-46c7-a977-eadc7616c8a1,
abstract = {{<p>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/m<sup>2</sup> (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.</p>}},
author = {{Janson, Annika and Järvholm, Kajsa and Gronowitz, Eva and Sjögren, Lovisa and Klaesson, Sven and Engström, My and Peltonen, Markku and Ekbom, Kerstin and Dahlgren, Jovanna and Olbers, Torsten}},
issn = {{2451-8654}},
keywords = {{Adolescents; Bariatric surgery; Low-calorie diet; Obesity; Pediatric; Roux-en Y gastric Bypass}},
language = {{eng}},
publisher = {{Elsevier}},
series = {{Contemporary Clinical Trials Communications}},
title = {{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}},
url = {{http://dx.doi.org/10.1016/j.conctc.2020.100592}},
doi = {{10.1016/j.conctc.2020.100592}},
volume = {{19}},
year = {{2020}},
}