Psychological Impact of Bariatric Surgery in Patients With Morbid Obesity: a Longitudinal Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Global Severity Index (GSI) score of the Symptom Checklist-90-Revised (SCL-90-R)
研究概览
简要总结
This prospective observational study evaluates the effect of bariatric surgery on mental health and hair cortisol in patients with morbid obesity over a 3-year follow-up. Assessments will be performed before surgery and at 1 month, 1 year, 2 years, and 3 years to analyze psychological changes, weight changes, and the need for psychological support.
详细描述
Objective
To evaluate the impact of bariatric surgery on mental health and hair cortisol concentrations in patients with morbid obesity over a 3-year follow-up.
Methods: This is a prospective observational study in candidates for bariatric surgery. Assessments will include sociodemographic data, anthropometric measures, clinical, nutritional and lifestyle variables, hair cortisol concentrations, and psychological variables, including psychopathological symptoms, stress levels, impulsivity, emotional eating, and health-related quality of life. Evaluations will be performed at five time points: preoperative (T0), 1 month (T1), 1 year (T2), 2 years (T3), and 3 years (T4). The study will describe psychological and weight changes after surgery and identify possible needs for psychological support before surgery and during mid- and long-term follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 70 years who are candidates for gastric bypass, sleeve gastrectomy, or single-anastomosis duodeno-ileal bypass (SADI-S), with a body mass index of at least 40 kg/m² or at least 35 kg/m² with comorbidities, and who are able to provide informed consent.
排除标准
- •Patients with previous bariatric surgery and pregnant women during follow-up will be excluded.
研究组 & 干预措施
Bariatric Surgery Group
Patients with severe obesity who are candidates for bariatric surgery.
结局指标
主要结局
Global Severity Index (GSI) score of the Symptom Checklist-90-Revised (SCL-90-R)
时间窗: Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.
Change in overall psychological distress assessed using the Global Severity Index (GSI) of the Symptom Checklist-90-Revised (SCL-90-R).
次要结局
- UPPS-P Short Version score(Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.)
- Perceived Stress Scale (PSS-14) score(Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.)
- Hair cortisol concentration(Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.)
- Moorehead-Ardelt Quality of Life Questionnaire II score(Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.)
- Eating Disorder Examination Questionnaire (EDE-Q) score(Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.)
- Emotional Eating Questionnaire (EEQ) score(Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.)
- Body weight(Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery)
- Body Mass Index (BMI)(Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.)
- Mediterranean Diet Adherence Screener (MEDAS) score(Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.)
- Sleep quality(Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.)
- Physical activity(Baseline (3 months before surgery), 1 month, 1 year, 2 years, and 3 years after bariatric surgery.)