Clinical trial NCT04248478: Eating Behaviours in Female Patients With Fibromyalgia
Official title: The Relationship Between Eating Behaviours and Health Status of Female Patients With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eating Behavior
Fibromyalgia
Health Status
Keywords: Chronic Pain
Eating Habits
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Mehmet Akif Ersoy Canakkale State Hospital
First posted: 2020-01-30
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with fibromyalgia and healthy volunteers are planned to be included in the study.

Brief summary: The Relationship Between Eating Behaviours and Health Status of Female Patients with Fibromyalgia

Detailed description: The purpose of this study is to evaluate the nutritional behaviours of female patients with fibromyalgia according to the healthy population and the relationship of these behaviours with the current health status of the patient.

In the investigatgor's clinical practice, eating-related problems (increased or decreased appetite, uncontrolled eating, etc.) are observed in fibromyalgia patients. In this study, it will be investigated whether this situation is different from healthy population and whether it is related with the healt status.

Patients diagnosed with fibromyalgia according to 2013 American College of Rheumatology criteria and healthy volunteers are planned to be included in the study.

Demographic data (sex, age, level of education, job, socio-economic situation) will be questioned and their body mass indexes (BMI) will be calculated from all participitants All participants' eating behaviour will be questioned with Three Factor Eating Questionnaire.

In fibromyalgia patients, effect of fibromyalgia on the daily life of the patients will be questioned with Fibromyalgia Impact Questionnaire.

Eligibility criteria: Inclusion Criteria:

* Female patients between the ages of 18-40
* Patients diagnosing fibromyalgia for the first time according by 2013 American College of Rheumatology (ACR) criteria

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: body mass index
timeFrame: 1 day
measure: sex
timeFrame: 1 day
measure: age
timeFrame: 1 day
measure: level of education
timeFrame: 1 day
measure: job
timeFrame: 1 day
measure: socio-economic situation
timeFrame: 1 day
Other outcomes:
Locations:
city: Çanakkale
country: Turkey
facility: Alper Mengi
Study officials:
affiliation: Canakkale State Hospital
name: Alper Mengi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: