Clinical trial NCT03394898: Evaluation of Body Mass Index and Eating Behaviour Changes in Female Patients With Fibromyalgia Under Medical Treatment
Official title: Prospective, Observational Study of Evaluation of Body Mass Index and Eating Behaviour Changes in Female Patients With Fibromyalgia Under Medical Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eating Behavior
Body Weight
Fibromyalgia
Keywords: Chronic Pain
Body Mass Index
Eating Habits
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2018-01-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who applied to the Physical Medicine and Rehabilitation outpatient clinic

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 .

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

Primary outcomes:
measure: eating behaviour
timeFrame: 7 days
Secondary outcomes:
measure: activities of daily living
timeFrame: 7 days
measure: calf circumference
timeFrame: 1 day
measure: body mass index
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Taksim Research and Education Hospital
Study officials:
affiliation: Gaziosmanpasa Taksim Training and Research Hospital
name: alper MENGİ, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.