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ObesityBaSESNCT05207917

How Does Bariatric Surgery Affect Social Experiences and Well-being - The BaSES-study

A study testing Gastric bypass, Sleeve gastrectomy and Single anastomosis sleeve ileal (SASI) bypass in people with Obesity, run by The Hospital of Vestfold at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Nonrandomized controlled trial to assess whether or not sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) affect social experiences and biomarkers of well-being 6 weeks and 1 year after surgery. The decision whether SG or RYGB will be performed is determined by medical decision making. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Gastric bypass, Sleeve gastrectomy and Single anastomosis sleeve ileal (SASI) bypass
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteNorway
Study dates
12 May 2022to 5 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • scheduled for bariatric surgery and eligible for sleeve gastrectomy or gastric bypass
  • able to give consent
  • understand written and spoken Norwegian

Who cannot join

  • pregnancy and breast-feeding
  • chronic disease (endocrine, heart, neurological, lung, gastrointestinal, kidney)
  • cancer
  • acute psychotic episode

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Morbid Obesity Center

    Tønsberg, Vestfold, 3103

Other trials in Norway

About this study

Official title: How Gastric Bypass and Sleeve Gastrectomy Change Social Experiences and Biomarkers of Well-being

Nonrandomized controlled trial to assess whether or not sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) affect social experiences and biomarkers of well-being 6 weeks and 1 year after surgery. The decision whether SG or RYGB will be performed is determined by medical decision making. Hypotheses: Bariatric surgery influences social experiences and well-being through changes in body image, reward responsivity and gut hormones. These changes may differ between gastric bypass (RYGB) and sleeve gastrectomy (SG).

Read the detailed description

Explanation for choice of comparators

Obesity is one of the world's most serious public health problems. Conservative weight reduction methods alone (diet, exercise) often show disappointing results, as the majority of people who lose weight regain it after a shorter or longer period of time. The currently most effective measure to achieve a durable weight-loss is bariatric surgery.

When investigating the effectiveness of bariatric surgery, the focus has most often been on weight loss and obesity-related complications, while effects on social interaction and subjective experience have received much less attention. A large body of evidence has demonstrated that (supportive) social relationships benefit health. Individuals with low compared to those with high levels of social connectedness are more likely to die prematurely; and social relationships can also affect a range of other health conditions such as cardiovascular disease, cancer, and immune function. Importantly, individuals with obesity may experience social interactions as less positive than normal-weight individuals. They recount avoiding social events and relationships, but also career opportunities, shopping and other activities where they feel observed because of weight stigma. Such avoidance behavior can lead to a "chronic disengagement" with many aspects of social life, which in turn might decrease interpersonal skills. Further investigations into the link between social behavior and eating found that greater emotional eating is associated with greater social avoidance. Eating was described a means to cope with loneliness on the one hand, while on the other hand aggravating feelings of being alone due to the stigma associated with obesity. This way, loneliness and obesity can create a vicious circle. In terms of how bariatric surgery influences social interactions, one 10-year follow up study found improvements in social interactions for bariatric surgery, but not for conventional weight loss treatment. In qualitative studies, many participants mentioned that they received more positive social feedback following bariatric surgery, and that they enjoyed social activities more than before, although they also describe ambiguous feelings.

The present study will investigate whether and how two types of bariatric surgery improve the response to a range of social aspects of patients' daily lives. Further, it aims to determine potential mechanisms leading to these effects, namely changes in body image, gut hormones, and reward responsivity.

Conditions
Obesity
Being tested
Gastric bypass, Sleeve gastrectomy, Single anastomosis sleeve ileal (SASI) bypass
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gastric bypassProcedure or surgery

    In Roux-en-Y gastric bypass (RYGB), the left crus will be dissected free, any hiatal hernia left in place. The minor curvature is opened at the second vessel and the lesser sac entered. A 25 mL gastric pouch will be created by firing one horizontal and two vertical staple loads. The ligament of Treitz is then identified and a proximal loop of small intestine anastomosed to the pouch 60 cm from the ligament of Treitz with one linear stapler (full length of the stapler), creating an antecolic, antegastric alimentary limb. The opening will be closed using a single row, running absorbable suture. An entero-enteroanastomosis will be made 120 cm distal of the gastro-enteroanastomosis. The introductory opening is closed with a single row, running absorbable suture. The small intestine will be divided with one load between the gastro-entero-enteroanastomosis and the entero-enteroanastomosis in order to complete a bypass with an alimentary limb of 120 cm and a biliopancreatic limb of 60 cm.

  • Sleeve gastrectomyProcedure or surgery

    In sleeve gastrectomy (SG) a large part (80%) of the ventricle is removed. The greater curvature will be dissected free starting 4-5 cm from the pylorus up to the angle of Hiss. The left crus is then visualized and inspected for hiatal hernia. Small sliding hernias and wide hiatus are left in situ. The ventricle will then be lifted and any adhesions in the lesser sac divided. A 35 Fr bougie is placed down to the pylorus guiding the creation of a tubular sleeve with linear staplers. The first two loads are always green or purple, while blue or tan loads are used for the rest of the ventricle. The last stapler is placed 5 mm laterally to the angle of Hiss. The staple line will then be inspected and secured with clips for additional haemostasis, no oversewing or buttressing material is routinely used.

  • Single anastomosis sleeve ileal (SASI) bypassProcedure or surgery

    The SASI bypass will performed with a similar entry of the abdominal cavity. A 6-port set up and a liver retractor is utilized. The small bowel is measured 300cm from the ileocecal valve, in sequences of 10cm, with the small bowel stretched and markers placed on the graspers, and connected to the antrum of the stomach with a 45mm stapler. The anastomosis is positioned slightly ventral on the antrum. The antrum is opened ventrally 5 cm proximal to the pylorus, just below the horizontal axis of canalis pylori. A 12 mm port positioned left to the midline is used for introduction of the stapler, which is directed distally from the patient's left to right side. 2.5 cm of the 45 mm stapler device is used for firing the anastomosis, which is completed with a 2-0 PDS running suture. The fascia defect is closed for the port where the specimen is extracted. The mesenteric defect is not closed.

Study groups in NCT05207917
Study groupRoleWhat they receive
Gastric bypassActive comparatorGastric bypass
Receives: Procedure: Gastric bypass
Sleeve gastrectomyActive comparatorSleeve gastrectomy
Receives: Procedure: Sleeve gastrectomy
Single anastomosis sleeve ileal (SASI) bypassExperimentalExploratory small arm with a small number of particpants
Receives: Procedure: Single anastomosis sleeve ileal (SASI) bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year changes in Social Experience

    10-item checklist assessing frequency and quality of daily social interactions (preprint in August 2025: https://osf.io/preprints/psyarxiv/6psar_v2); 2 sub-scales: (1) Being with others, (2) Being alone; the diary will be filled in 14 days in a row at the end of the day. Scale (1) was designed to measure enjoyment of being with others and the duration of social contact (6 items, range: 4 to 62.4), higher values indicate more enjoyment and a higher frequency of social contact. Scale (2) was designed to measure enjoyment of being alone (3 items, range: -5 to 20), higher values here indicate more enjoyment of being alone. An additional item at the beginning of the checklists asks how many people the respondent has had social contact with during the day (5 categories).

    Measured: Change from 4 weeks before surgery to 1 year after surgery

Secondary outcomes (22)
  1. Changes in affect ratings after social evaluation (inclusion and exclusion)

    Positive and Negative Affect Schedule (PANAS): The PANAS is a self-report measure that is made up of two mood scales of 10 adjectives each, one measuring positive affect and the other one measuring negative affect. (1) Positive Affect Scale (range: 10-50; higher values indicate higher positive affect); (2) Negative Affect Scale (range: 10-50, higher values indicate higher negative affect)

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  2. Changes in experience ratings after social evaluation (inclusion and exclusion)

    Need-Threat Scale: 4 sub-scales: (1) Belonging, (2) Self-Esteem, (3) Meaningful existence, (4) Control; range: 3-27 per sub-scale; higher values indicate more belonging, higher self-esteem, higher meaningful existence, and more control)

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  3. Changes in pleasantness ratings in response to touch stimulation on the forearm

    Subjective ratings on a digitally presented visual analogue scale (VAS) scale: range 0-100 (unpleasant - pleasant) after a touch stimulation to the forearm (repeated 10 times)

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  4. Changes in pleasantness ratings in response to self-stroking on the forearm

    Subjective ratings on a digitally presented VAS scale: range 0-100 (unpleasant - pleasant), after participants made 10 back-and-forth strokes on their forearm with their hand

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  5. Changes in intensity ratings in response to touch stimulation on the forearm

    Subjective ratings on a digitally presented VAS scale: range 0-100 (not intense - intense), after a touch stimulation to the forearm (repeated 10 times)

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  6. Changes in intensity ratings in response to self-stroking on the forearm

    Subjective ratings on a digitally presented VAS scale: range 0-100 (not intense - intense), after participants made 10 back-and-forth strokes on their forearm with their hand

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  7. Changes in self-stroking velocity

    Participants are instructed to stroke their own forearm with a velocity they experience as pleasant. The duration of 10 back-and-forth strokes over a 10 cm distance on the forearm will be measured with a stop watch. Velocity in cm/sec will be calculated thereafter.

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  8. Changes in cortisol levels from hair samples

    Cortisol (in pg/mg)

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  9. Changes in endocannabinoid levels from hair samples

    Endocannabinoids (in pg/mg)

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  10. Changes in fasting ghrelin levels from blood samples

    Ghrelin (in pg/ml)

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  11. Changes in body image

    Questionnaires: Appearance Evaluation Scale (AES) and the Body Areas Satisfaction Scale (BASS) - the AES was designed to measure overall satisfaction/dissatisfaction with one's appearance and physical attractiveness. It has 7 items (range: 5-35) with high scores indicating body satisfaction and low scores indicating body dissatisfaction. The BASS was designed to measure the degree of dissatisfaction-satisfaction with specific body areas and attributes (range: 9-45). Higher scores indicate greater body satisfaction and lower scores indicate greater body dissatisfaction.

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  12. Changes in reward responsivity

    Questionnaire: Temporal Experience of Pleasure Scale (TEPS) - the TEPS was designed to measure individual trait dispositions in both anticipatory and consummatory experiences of pleasure. It consists of 18 items, of which 10 form the (1) anticipatory pleasure scale (range: 10-60), and (2) 8 items for the consummatory pleasure scale (range: 8-48). Higher values on (1) indicate enhanced reward responsiveness and imagery, while higher values on (2) indicate higher openness to different experiences and appreciation of positive stimuli.

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  13. Changes in interoceptive ability

    Questionnaire: Body Awareness Questionnaire (BAQ) - the BAQ was designed to assess self-reported attentiveness to normal nonemotive body processes, such as sensitivity to body rhythms, ability to detect small changes in normal bodily functioning, and one's ability to anticipate bodily reactions. It consists of 18 items (range: 18-126). Higher values indicate a higher sensitivity and awareness of one's bodily states.

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  14. Changes in belongingness

    Questionnaires: The Social Connectedness Scale Revised (SCS-R) and the Social Assurance Scale (SAS). The SCS-R was designed to measure a psychological sense of belonging, or how individuals cognitively construe interpersonal closeness with others in their social world. It consists of 20 items (range: 20-120), with higher values indicating a higher sense of belonging. The SAS was designed to measure the importance of assurance from one's social group.It consists of 8 items (range: 8-48), with higher values indicating a higher need for social assurance.

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  15. Changes in social network size

    Questionnaire: The Social Network Index (SNI) - the SNI was designed to measure three aspects of one's social networks: (1) network diversity, (2) number of people in the network, and (3) number of embedded networks. Each of the three sub-scales is assessed on 12 items. (1) refers to the number of high-contact roles (range: 0-12), with higher values indicating a higher number of social roles. (2) refers to the total number of people with whom the respondent has regular contact, which will be summed for the 12 items (range: 0-70). Higher numbers indicate more people in one's network (to not inflate the number, items 4-12 will be scored with 7 in case the reported number of people in this group is equivalent or larger to 7). The embedded network scale (3) reflects the number of different network domains in which a respondent is active (range: 0-8), with higher numbers indicating activity in more network domains.

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  16. Changes in self-reported eating patterns

    Questionnaire:The Three Factor Eating Questionnaire -R 21 (TFEQ-R21) measures eating behaviour and has been validated for use in individuals with obesity and will be used in the study. It consists of 21 items comprising three domain scores; (1) uncontrolled eating; assessing the tendency to lose control over eating when feeling hungry or when exposed to external stimuli, (2) cognitive restraint; assessing the conscious restriction of food intake to control body weight or body shape, and (3) emotional eating; assessing overeating related to negative mood states. The domain scores were transformed to 0-100 scales to facilitate comparison; a higher score indicates more uncontrolled, restraint, or emotional eating.

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  17. Changes in symptoms of depression and anxiety

    Questionnaire: Hospital Anxiety and Depression Scale (HADS). The validated generic HADS measures symptoms of anxiety and depression using 14 items scored from 0-3 It is decomposed into two domains measuring depression (HADS-D) and anxiety (HADS-A), both consisting of seven items yielding a score from 0-21.

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  18. Changes in Health Related Quality of Life 1

    Generic questionnaire: Short Form-36 Health Survey (SF-36). Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores for each of the 8 domains and summary scores for physical and mental health will be calculated.

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  19. Changes in Health Related Quality of Life 2

    Questionnaire: Weight-related Symptom Measure (WRSM). The validated obesity specific WRSM measures 20 symptoms commonly related to being overweight or obese, including foot problems, joint pain, sensitivity to cold, shortness of breath, etc. using two different sets of items. The first set assesses whether or not a patient is experiencing specific symptoms, and the second set rates the level of the distress of the symptoms with values from zero ("not at all") to six ("bothers a very great deal"). The first set creates an additive scale summing symptoms from 0-20, while the second forms a symptom distress scale ranging from 0-120.

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  20. Changes in Health Related Quality of Life 3

    Obesity specific questionnaire: The Impact of Weight on Quality of Life-Lite (IWQOL-lite). The IWQOL-Lite is a 31-item measure of weight-related quality of life. There are five domain scores (Physical Function, Self-Esteem, Sexual Life, Public Distress and Work) and a total score. Scores for all domains and total score range from 0-100, with lower scores indicating greater impairment.

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

  21. 6-week Changes in Social Experience

    10-item checklist assessing frequency and quality of daily social interactions (preprint in August 2025: https://osf.io/preprints/psyarxiv/6psar_v2); 2 sub-scales: (1) Being with others, (2) Being alone; the diary will be filled in 14 days in a row at the end of the day. Scale (1) was designed to measure enjoyment of being with others and the duration of social contact (6 items, range: 4 to 62.4), higher values indicate more enjoyment and a higher frequency of social contact. Scale (2) was designed to measure enjoyment of being alone (3 items, range: -5 to 20), higher values here indicate more enjoyment of being alone. An additional item at the beginning of the checklists asks how many people the respondent has had social contact with during the day (5 categories).

    Measured: Change from 4 weeks before surgery to 6 weeks after surgery

  22. Group differences between SG and RYBG patients in the above-mentioned outcomes [1-22]

    The above-mentioned outcomes will be tested for differences between the two surgery types.

    Measured: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start12 May 2022
  3. Primary completion5 Nov 2025
  4. Study completion5 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
2 intervention groups with either sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) surgery; in addition one small exploratory group undergoing undergoing single anastomosis sleeve ileal (SASI) bypass
Masking
None (open label)
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05207917
Sponsor's protocol ID
238406
Acronym
BaSES
Status last verified
Sep 2026
First submitted
8 Dec 2021
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-anonymized individual participant data can be made available following publication upon reasonable request to authors Jøran Hjelmesæth and Uta Sailer. Data will be shared according to the consent given by the participants and Norwegian laws and legislation.

Publications

  • Broadhead WE, Kaplan BH, James SA, Wagner EH, Schoenbach VJ, Grimson R, Heyden S, Tibblin G, Gehlbach SH. The epidemiologic evidence for a relationship between social support and health. Am J Epidemiol. 1983 May;117(5):521-37. doi: 10.1093/oxfordjournals.aje.a113575. No abstract available.

    PubMed 6342368
  • Uchino BN. Social support and health: a review of physiological processes potentially underlying links to disease outcomes. J Behav Med. 2006 Aug;29(4):377-87. doi: 10.1007/s10865-006-9056-5. Epub 2006 Jun 7.

    PubMed 16758315
  • Umberson D, Montez JK. Social relationships and health: a flashpoint for health policy. J Health Soc Behav. 2010;51 Suppl(Suppl):S54-66. doi: 10.1177/0022146510383501.

    PubMed 20943583
  • Maphis LE, Martz DM, Bergman SS, Curtin LA, Webb RM. Body size dissatisfaction and avoidance behavior: how gender, age, ethnicity, and relative clothing size predict what some won't try. Body Image. 2013 Jun;10(3):361-8. doi: 10.1016/j.bodyim.2013.02.003. Epub 2013 Mar 27.

    PubMed 23540887
  • Brytek-Matera A, Czepczor-Bernat K, Olejniczak D. Food-related behaviours among individuals with overweight/obesity and normal body weight. Nutr J. 2018 Oct 16;17(1):93. doi: 10.1186/s12937-018-0401-7.

    PubMed 30326901
  • Karlsson J, Taft C, Ryden A, Sjostrom L, Sullivan M. Ten-year trends in health-related quality of life after surgical and conventional treatment for severe obesity: the SOS intervention study. Int J Obes (Lond). 2007 Aug;31(8):1248-61. doi: 10.1038/sj.ijo.0803573. Epub 2007 Mar 13.

    PubMed 17356530
  • Coulman KD, MacKichan F, Blazeby JM, Owen-Smith A. Patient experiences of outcomes of bariatric surgery: a systematic review and qualitative synthesis. Obes Rev. 2017 May;18(5):547-559. doi: 10.1111/obr.12518. Epub 2017 Mar 8.

    PubMed 28273694
  • Pfabigan DM, Hertel JK, Svanevik M, Lindberg M, Sailer U, Hjelmesaeth J. Single-centre, non-randomised clinical trial at a tertiary care centre to investigate 1-year changes in social experiences and biomarkers of well-being after bariatric surgery in individuals with severe obesity: protocol for the Bariatric Surgery and Social Experiences (BaSES) study. BMJ Open. 2023 Aug 28;13(8):e071332. doi: 10.1136/bmjopen-2022-071332.

    PubMed 37640458

Questions about this trial

What is this clinical trial studying?

A study testing Gastric bypass, Sleeve gastrectomy and Single anastomosis sleeve ileal (SASI) bypass in people with Obesity, run by The Hospital of Vestfold at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year changes in Social Experience (time frame: Change from 4 weeks before surgery to 1 year after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05207917, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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