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.
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.
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 group | Role | What they receive |
|---|---|---|
| Gastric bypass | Active comparator | Gastric bypass Receives: Procedure: Gastric bypass |
| Sleeve gastrectomy | Active comparator | Sleeve gastrectomy Receives: Procedure: Sleeve gastrectomy |
| Single anastomosis sleeve ileal (SASI) bypass | Experimental | Exploratory 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-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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted26 Jan 2022
- Study start12 May 2022
- Primary completion5 Nov 2025
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Hospital of Vestfold
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Jøran Hjelmesæth, The Hospital of Vestfold
- Investigators
- Jøran Hjelmesæth, Professor, Principal investigator, The Hospital of Vestfold
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 6342368Uchino 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 16758315Umberson 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 20943583Maphis 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 23540887Brytek-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 30326901Karlsson 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 17356530Coulman 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 28273694Pfabigan 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Gastric Bypass and Sleeve Gastrectomy Change Social Experiences and Biomarkers of Well-being
- ClinicalTrials.gov ID
- NCT05207917
- Acronym / sponsor ID
- BaSES / 238406
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- The Hospital of VestfoldUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 12 May 2022 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass | Active comparator | Procedure: Gastric bypassGastric bypass |
| Sleeve gastrectomy | Active comparator | Procedure: Sleeve gastrectomySleeve gastrectomy |
| Single anastomosis sleeve ileal (SASI) bypass | Experimental | Procedure: Single anastomosis sleeve ileal (SASI) bypassExploratory small arm with a small number of particpants |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- scheduled for bariatric surgery and eligible for sleeve gastrectomy or gastric bypass
- able to give consent
- understand written and spoken Norwegian
Key exclusion criteria (4 listed)
- pregnancy and breast-feeding
- chronic disease (endocrine, heart, neurological, lung, gastrointestinal, kidney)
- cancer
- acute psychotic episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric bypassIn 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. | Procedure or surgery | Gastric bypass |
| Sleeve gastrectomyIn 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. | Procedure or surgery | Sleeve gastrectomy |
| Single anastomosis sleeve ileal (SASI) bypassThe 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. | Procedure or surgery | Single anastomosis sleeve ileal (SASI) bypass |
Primary outcome
1-year changes in Social Experience
Time frame: Change from 4 weeks before surgery to 1 year after surgery
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).
22 secondary outcomes
Changes in affect ratings after social evaluation (inclusion and exclusion)
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in experience ratings after social evaluation (inclusion and exclusion)
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in pleasantness ratings in response to touch stimulation on the forearm
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in pleasantness ratings in response to self-stroking on the forearm
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in intensity ratings in response to touch stimulation on the forearm
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in intensity ratings in response to self-stroking on the forearm
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in self-stroking velocity
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in cortisol levels from hair samples
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in endocannabinoid levels from hair samples
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in fasting ghrelin levels from blood samples
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in body image
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in reward responsivity
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in interoceptive ability
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in belongingness
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in social network size
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in self-reported eating patterns
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in symptoms of depression and anxiety
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in Health Related Quality of Life 1
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in Health Related Quality of Life 2
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Changes in Health Related Quality of Life 3
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
6-week Changes in Social Experience
Time frame: Change from 4 weeks before surgery to 6 weeks after surgery
Group differences between SG and RYBG patients in the above-mentioned outcomes [1-22]
Time frame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 6342368Broadhead 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.
- Background: PubMed 16758315Uchino 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.
- Background: PubMed 20943583Umberson 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.
- Background: PubMed 23540887Maphis 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.
- Background: PubMed 30326901Brytek-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.
- Background: PubMed 17356530Karlsson 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.
- Background: PubMed 28273694Coulman 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.
- Derived from this study: PubMed 37640458Pfabigan 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.
- Individual participant dataSharing planned: 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.
Related trials for Obesity
RecruitingPhase 4
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Class I/II Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Overweight and Obesity
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jøran Hjelmesæth, Professor principal investigator
The Hospital of Vestfold
1 site in 1 country: see every site and its status.
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.