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临床试验/NCT04248478
NCT04248478Unknown不适用

The Relationship Between Eating Behaviours and Health Status of Female Patients With Fibromyalgia

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年1月29日最近更新:
适应症

试验速览

阶段
不适用
入组人数
110
试验地点
1
主要终点
eating behaviour

研究概览

简要总结

The Relationship Between Eating Behaviours and Health Status of Female Patients with Fibromyalgia

详细描述

The purpose of this study is to evaluate the nutritional behaviours of female patients with fibromyalgia according to the healthy population and the relationship of these behaviours with the current health status of the patient.

In the investigatgor's clinical practice, eating-related problems (increased or decreased appetite, uncontrolled eating, etc.) are observed in fibromyalgia patients. In this study, it will be investigated whether this situation is different from healthy population and whether it is related with the healt status.

Patients diagnosed with fibromyalgia according to 2013 American College of Rheumatology criteria and healthy volunteers are planned to be included in the study.

Demographic data (sex, age, level of education, job, socio-economic situation) will be questioned and their body mass indexes (BMI) will be calculated from all participitants All participants' eating behaviour will be questioned with Three Factor Eating Questionnaire.

In fibromyalgia patients, effect of fibromyalgia on the daily life of the patients will be questioned with Fibromyalgia Impact Questionnaire.

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Female patients between the ages of 18-40
  • Patients diagnosing fibromyalgia for the first time according by 2013 American College of Rheumatology (ACR) criteria

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

Participants' eating behaviour will be questioned with Three Factor Eating Questionnaire (TFEQ). The TFEQ contains 51 items (questions) and measures three dimensions of human eating behavior 'cognitive restraint of eating' (Factor I - 21 items) 'disinhibition' (Factor II - 16 items) 'hunger' (Factor III - 14 items). Each item scores either 0 or 1 point. The minimum score for factors I-II-III is therefore 0-0-0, the possible maximum score 21-16-14.

次要结局

  • job(1 day)
  • age(1 day)
  • level of education(1 day)
  • activities of daily living(7 days)
  • body mass index(1 day)
  • sex(1 day)
  • socio-economic situation(1 day)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Alper Mengi

Medical Doctor, Physiatrist

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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