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 Expe

Abstract

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 sør-øst 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.

Strengths and limitations of this study

Pioneering 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.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT05207917

Funding Statement

This study was funded by the South-Eastern Norway Regional Health Authority (grant number: 2021046), the Vestfold Hospital Trust, and The Morbid Obesity Centre.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Regional Committee for Medical Research Ethics South East Norway (REK sor-ost A) gave ethical approval for this work on the 29th of August 2022 (ref: 238406).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Footnotes

Daniela M. Pfabigan: d.m.pfabiganmedisin.uio.no;

Jens K. Hertel: jehertsiv.no;

Marius Svanevik: marius.svaneviksiv.no;

Morten Lindberg: morten.lindbergsiv.no;

Uta Sailer: uta.sailermedisin.uio.no;

Jøran Hjelmesæth: joran.hjelmesethsiv.no;

Data Availability

De-anonymized individual participant data can be made available following publication upon reasonable request to authors US and JH. Data will be shared according to the consent given by the participants and Norwegian laws and legislations.

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