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Clinical Trials/NCT03394898
NCT03394898
Unknown
Not Applicable

Prospective, Observational Study of Evaluation of Body Mass Index and Eating Behaviour Changes in Female Patients With Fibromyalgia Under Medical Treatment

Gaziosmanpasa Research and Education Hospital1 site in 1 country100 target enrollmentJanuary 3, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eating Behavior
Sponsor
Gaziosmanpasa Research and Education Hospital
Enrollment
100
Locations
1
Primary Endpoint
eating behaviour
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to evaluate of body mass index and eating behaviour changes in female patients with fibromyalgia under medical treatment.

Detailed Description

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. In each follow-up, 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. In each follow-up, the right calf circumference of the patients will be measured in centimeters with a tape measure .

Registry
clinicaltrials.gov
Start Date
January 3, 2018
End Date
November 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alper Mengi

Alper Mengi, M.D.

Gaziosmanpasa Research and Education Hospital

Eligibility Criteria

Inclusion Criteria

  • Female subjects between the ages of 18-40
  • Subjects, who met the 2013 American College of Rheumatology (ACR) criteria for Fibromyalgia

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

eating behaviour

Time Frame: 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.

Secondary Outcomes

  • calf circumference(1 day)
  • body mass index(1 day)
  • activities of daily living(7 days)

Study Sites (1)

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