Prospective, Observational Study of Evaluation of Body Mass Index and Eating Behaviour Changes in Female Patients With Fibromyalgia Under Medical Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- eating behaviour
研究概览
简要总结
The purpose of this study is to evaluate of body mass index and eating behaviour changes in female patients with fibromyalgia under medical treatment.
详细描述
The female patients with fibromyalgia under medical treatment say that body mass index and eating behaviour changes,for this reason, this relationship will be investigated in this study.
Demographic data (sex, age, education level, occupation) of patients with fibromyalgia diagnosis will be questioned and height lengths will be measured. The group of medications (serotonin and norepinephrine reuptake inhibitor or GABAergic drugs) that begins with the diagnosis of the disease fibromyalgia will be recorded.
All patients will be assessed when diagnosed, followed by 2nd week and then 4nd week.
In each follow-up, the patients' weights will be measured again (the body mass index will be calculated from the measured value).
In each follow-up, the effect of fibromyalgia on the daily life of the patients will be questioned with Fibromyalgia Impact Questionnaire (FIQ). The FIQ was developed from information gathered from patient reports, functional status instruments, and clinical observations. This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects between the ages of 18-40
- •Subjects, who met the 2013 American College of Rheumatology (ACR) criteria for Fibromyalgia
排除标准
- •History of eating disorders such as anorexia nervosa, bulimia nevroza
- •History of hypothyroidism or hyperthyroidism
- •Pregnant or breast feeding
- •History of central or peripheral nervous system disorders
- •History of infectious, chronic inflammatory disease, malignant tumors
- •Subjects with active psychiatric illness or who use psychiatric medication
- •Uncooperative subject
- •History of cardiac pathology such as heart failure, coronary artery disease
- •History of diabetes, chronic renal insufficiency, chronic liver failure
结局指标
主要结局
eating behaviour
时间窗: 7 days
Patients' eating behaviour will be questioned with Three Factor Eating Questionnaire. The 18-item Three-Factor Eating Questionnaire is a scale that measures three domains of eating behavior: cognitive restraint , uncontrolled eating and emotional eating.
次要结局
- calf circumference(1 day)
- body mass index(1 day)
- activities of daily living(7 days)
研究者
Alper Mengi
Alper Mengi, M.D.
Gaziosmanpasa Research and Education Hospital