How Gastric Bypass and Sleeve Gastrectomy Change Social Experiences and Biomarkers of Well-being
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- 1-year changes in Social Experience
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •scheduled for bariatric surgery and eligible for sleeve gastrectomy or gastric bypass
- •able to give consent
- •understand written and spoken Norwegian
排除标准
- •pregnancy and breast-feeding
- •chronic disease (endocrine, heart, neurological, lung, gastrointestinal, kidney)
- •acute psychotic episode
结局指标
主要结局
1-year changes in Social Experience
时间窗: 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).
1-year changes in Social Experience
时间窗: 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).
次要结局
- Changes in pleasantness ratings in response to self-stroking on the forearm(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(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(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in cortisol levels from hair samples(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in endocannabinoid levels from hair samples(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in fasting ghrelin levels from blood samples(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in body image(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in reward responsivity(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in interoceptive ability(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in belongingness(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in affect ratings after social evaluation (inclusion and exclusion)(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in experience ratings after social evaluation (inclusion and exclusion)(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(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in social network size(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in self-reported eating patterns(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in symptoms of depression and anxiety(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in Health Related Quality of Life 1(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in Health Related Quality of Life 2(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in Health Related Quality of Life 3(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- 6-week Changes in Social Experience(Change from 4 weeks before surgery to 6 weeks after surgery)
- Changes in affect ratings after social evaluation (inclusion and exclusion)(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(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(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(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in experience ratings after social evaluation (inclusion and exclusion)(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(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in self-stroking velocity(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in cortisol levels from hair samples(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in endocannabinoid levels from hair samples(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in fasting ghrelin levels from blood samples(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in body image(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in reward responsivity(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in interoceptive ability(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in belongingness(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in social network size(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in self-reported eating patterns(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in symptoms of depression and anxiety(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in Health Related Quality of Life 1(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in Health Related Quality of Life 2(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- Changes in Health Related Quality of Life 3(Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
- 6-week Changes in Social Experience(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](Change from 4 weeks before surgery to 6 weeks and 1 year after surgery)
研究者
Jøran Hjelmesæth
Professor
The Hospital of Vestfold