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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03394898
• Other study ID #: 27.12.2017/108
• Status: Recruiting
• Start date: January 3, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: July 2019
• Source: Gaziosmanpasa Taksim Research and Education Hospital
• Contact: Ömer Necati Develioglu, M.D.
• Phone: +90 212 945 30 00
• Email: taksimetikkurul[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Eating Behavior
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Taksim Research and Education Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Taksim Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eating behaviour	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.	7 days
Secondary	activities of daily living	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.	7 days
Secondary	calf circumference	The right calf circumference of the patients will be measured in centimeters with a tape measure .	1 day
Secondary	body mass index	The patients' weights and heights will be measured and the body mass index will be calculated from the measured values.	1 day