Eating Behaviours in Female Patients With Fibromyalgia

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

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

Study Overview

• Status: Unknown
• Conditions: Fibromyalgia; Eating Behavior; Health Status
• Intervention / Treatment: Other: Eating Behaviours; Other: Health Status

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.

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

• Study Contact: Name: Alper Mengi, M.D.; Phone Number: +90 5376510385; Email: a_mengi22@hotmail.com

Study Locations

• Turkey
  • Çanakkale, Turkey, 17100
    • Recruiting
    • Alper Mengi
    • Contact: Alper Mengi, M.D.; Phone Number: +90 537 651 03 85; Email: a_mengi22@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with fibromyalgia and healthy volunteers are planned to be included in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fibromiyalgia Patients; Patients diagnosed with fibromyalgia according to 2013 American College of Rheumatology criteria are planned to be included in this arm.	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.; Other: 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.
Healthy Volunteers; Healthy volunteers are planned to be included in this arm.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
sex	It will be registered as male or female.	1 day
age	The age of the participant will be recorded.	1 day
level of education	The education status will be recorded as not literate, primary school, secondary school, high school or university.	1 day
job	The job will be recorded as unemployed, housewife, office worker or heavy duty worker.	1 day
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

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital
• Collaborators: Mehmet Akif Ersoy Canakkale State Hospital
• Investigators: Principal Investigator: Alper Mengi, M.D., Canakkale State Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2020
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (ACTUAL): January 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 3, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Chronic Pain; Eating Habits
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: KAEK-27/2020-2000006994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No