Clinical trial NCT05207917: How Does Bariatric Surgery Affect Social Experiences and Well-being - The BaSES-study
Official title: How Gastric Bypass and Sleeve Gastrectomy Change Social Experiences and Biomarkers of Well-being
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity
Lead sponsor: The Hospital of Vestfold
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2022-01-26
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Nonrandomized controlled trial to assess whether or not sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) affect social experiences and biomarkers of well-being differently 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 1-year changes in Social Experience
timeFrame: Change from 4 weeks before surgery to 1 year after surgery
Secondary outcomes:
measure: Changes in affect ratings after social evaluation (inclusion and exclusion)
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in experience ratings after social evaluation (inclusion and exclusion)
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in pleasantness ratings in response to touch stimulation on the forearm
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in pleasantness ratings in response to self-stroking on the forearm
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in intensity ratings in response to touch stimulation on the forearm
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in intensity ratings in response to self-stroking on the forearm
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in cortisol levels from hair samples
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in endocannabinoid levels from hair samples
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in fasting ghrelin levels from blood samples
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in glucagon-like peptide 1 (GLP-1) levels from blood samples
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in body image
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in reward responsivity
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in interoceptive ability
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in belongingness
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in social network size
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in self-reported eating patterns
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in symptoms of depression and anxiety
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in Health Related Quality of Life 1
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in Health Related Quality of Life 2
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Changes in Health Related Quality of Life 3
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: 6-week Changes in Social Experience
timeFrame: Change from 4 weeks before surgery to 6 weeks after surgery
Other outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Change in weight
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Change in anthropometric measures
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Change in body fat
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Change in muscle mass
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Change in bone mass
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Change in blood pressure
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Change in lipids
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Change in glucose parameters
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Change in C-reactive protein (CRP)
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Change in blood enzymes
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Change in hemoglobin
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
measure: Change in ferritin
timeFrame: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery
Locations:
city: Tønsberg
country: Norway
facility: Morbid Obesity Center
state: Vestfold
Study officials:
affiliation: The Hospital of Vestfold
name: Jøran Hjelmesæth, Professor
role: PRINCIPAL_INVESTIGATOR
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