Single-centre, non-randomised clinical trial to investigate the effects of bariatric surgery on social experiences and biomarkers of well-being one year after surgery in individuals with severe obesity: a protocol for the Bariatric Surgery and Social Experiences (BaSES) study

Abstract

AbstractIntroductionObesity is linked to increased loneliness and less enjoyment of social interactions. While bariatric surgery is the most effective treatment targeting morbid obesity, there is limited understanding as to whether patients experience social interactions differently after surgery. The Bariatric Surgery and Social Experiences Study (BaSES) is designed to assess potential changes in how much patients enjoy and engage in daily social interactions 1 year after Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG).Methods and analysisSingle-centre, non-randomised clinical trial carried out at the Morbid Obesity Centre at Vestfold Hospital Trust, Norway. Eligible patients will undergo either RYGB, SG or single anastomosis sleeve ileal bypass (SASI). The primary outcome measure is change in the social experience score (assessed with a questionnaire) from a pre-surgery to a follow-up assessment 1 year after RYGB and SG. The respective changes after SASI will be assessed and considered exploratory.Ethics and disseminationThe most recent protocol version of this study was reviewed and approved by the Regional Committee for Medical Research Ethics South East Norway (REK sør-øst A) on the 29thof August 2022 (ref: 238406). The results will be disseminated to academic and health professional audiences and the public via publications in international peer-reviewed journals and conferences.Trial registration numberNCT05207917 (ClinicalTrials.gov)Article SummaryStrengths and limitations of this studyPioneering trial to assess changes in enjoyment and frequency of daily social interactions after bariatric surgery.Multiple clinically relevant secondary outcomes including hair cortisol and endocannabinoid concentrations, fasting ghrelin concentrations, cardiovascular risk factors and health-related and psychological patient-reported-outcomes (PROs) are assessed.Application of a bio-psycho-social approach to capture bariatric surgery outcomes.The sample size is limited and thus may not provide sufficient statistical power to compare the effects of RYGB and SG on secondary outcomes.