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

Introduction Obesity 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 analysis Single-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 dissemination The most recent protocol version of this study was reviewed and approved by the Regional Committee for Medical Research Ethics South East Norway (REK sor-ost A) on the 29th of 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 number: NCT05207917 (ClinicalTrials.gov) Keywords: social functioning, quality of life, loneliness, ghrelin, endocannabinoids