Evaluation of Body Mass Index and Eating Behaviour Changes in Female Patients With Fibromyalgia Under Medical Treatment
NCT ID: NCT03394898
Last Updated: 2019-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2018-01-03
2019-11-01
Brief Summary
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Detailed Description
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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 .
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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body mass index, eating behaviour
The patients' weights and heights will be measured and the body mass index will be calculated from the measured values.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.
Eligibility Criteria
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Inclusion Criteria
* Subjects, who met the 2013 American College of Rheumatology (ACR) criteria for Fibromyalgia
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Gaziosmanpasa Research and Education Hospital
OTHER_GOV
Responsible Party
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Alper Mengi
Alper Mengi, M.D.
Principal Investigators
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alper MENGİ, M.D.
Role: PRINCIPAL_INVESTIGATOR
Gaziosmanpasa Taksim Training and Research Hospital
Locations
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Gaziosmanpasa Taksim Research and Education Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Kim CH, Luedtke CA, Vincent A, Thompson JM, Oh TH. Association of body mass index with symptom severity and quality of life in patients with fibromyalgia. Arthritis Care Res (Hoboken). 2012 Feb;64(2):222-8. doi: 10.1002/acr.20653.
Other Identifiers
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27.12.2017/108
Identifier Type: -
Identifier Source: org_study_id
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