Eating Behaviours in Female Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

The Relationship Between Eating Behaviours and Health Status of Female Patients With Fibromyalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04248478
• Other study ID #: KAEK-27/2020-2000006994
• Status: Recruiting
• Start date: January 29, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: May 2020
• Source: Gaziosmanpasa Taksim Research and Education Hospital
• Contact: Alper Mengi, M.D.
• Phone: +90 5376510385
• Email: a_mengi22[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Eating Behavior
• Fibromyalgia
• Health Status
• Myofascial Pain Syndromes

Intervention

Other:
• Eating Behaviours
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.
• Health Status
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.

Locations

Country	Name	City	State
Turkey	Alper Mengi	Çanakkale

Sponsors (2)

Lead Sponsor	Collaborator
Gaziosmanpasa Taksim Research and Education Hospital	Mehmet Akif Ersoy Canakkale State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eating behaviour	Participants' eating behaviour will be questioned with Three Factor Eating Questionnaire (TFEQ). The TFEQ contains 51 items (questions) and measures three dimensions of human eating behavior 'cognitive restraint of eating' (Factor I - 21 items) 'disinhibition' (Factor II - 16 items) 'hunger' (Factor III - 14 items). Each item scores either 0 or 1 point. The minimum score for factors I-II-III is therefore 0-0-0, the possible maximum score 21-16-14.	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 10 items (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. The maximum possible score of each subtitle is 10. Thus, the total maximum score is 100, a lower score indicates better quality of life.	7 days
Secondary	body mass index	The participants' weights and heights will be measured and the body mass index will be calculated from the measured values.	1 day
Secondary	sex	It will be registered as male or female.	1 day
Secondary	age	The age of the participant will be recorded.	1 day
Secondary	level of education	The education status will be recorded as not literate, primary school, secondary school, high school or university.	1 day
Secondary	job	The job will be recorded as unemployed, housewife, office worker or heavy duty worker.	1 day
Secondary	socio-economic situation	Socio-economic situation will be recorded as income less than expense, income equal to expense or income lower than expense.	1 day