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

• Conditions: Eating Behavior; Fibromyalgia; Body Weight

• Registration Number: NCT03394898
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

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 .

Study Timeline

• Study Start: 2018-01-03
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-30
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eating behaviour	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 Outcome Measures

Name	Time	Method
calf circumference	1 day	The right calf circumference of the patients will be measured in centimeters with a tape measure .
body mass index	1 day	The patients' weights and heights will be measured and the body mass index will be calculated from the measured values.
activities of daily living	7 days	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.

Trial Locations

Locations (1)

Gaziosmanpasa Taksim Research and Education Hospital; 🇹🇷 Istanbul, Turkey