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Eating Behaviours in Female Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT04248478
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
Mehmet Akif Ersoy Canakkale State Hospital
Information provided by (Responsible Party):
Alper Mengi, Gaziosmanpasa Taksim Research and Education Hospital

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

Condition or disease Intervention/treatment
Eating Behavior Fibromyalgia Health Status 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.

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Relationship Between Eating Behaviours and Health Status of Female Patients With Fibromyalgia
Actual Study Start Date : January 29, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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.




Primary Outcome Measures :
  1. eating behaviour [ Time Frame: 7 days ]
    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.


Secondary Outcome Measures :
  1. activities of daily living [ Time Frame: 7 days ]
    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.

  2. body mass index [ Time Frame: 1 day ]
    The participants' weights and heights will be measured and the body mass index will be calculated from the measured values.

  3. sex [ Time Frame: 1 day ]
    It will be registered as male or female.

  4. age [ Time Frame: 1 day ]
    The age of the participant will be recorded.

  5. level of education [ Time Frame: 1 day ]
    The education status will be recorded as not literate, primary school, secondary school, high school or university.

  6. job [ Time Frame: 1 day ]
    The job will be recorded as unemployed, housewife, office worker or heavy duty worker.

  7. socio-economic situation [ Time Frame: 1 day ]
    Socio-economic situation will be recorded as income less than expense, income equal to expense or income lower than expense.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with fibromyalgia and healthy volunteers are planned to be included in the study.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04248478


Contacts
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Contact: Alper Mengi, M.D. +90 5376510385 a_mengi22@hotmail.com

Locations
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Turkey
Alper Mengi Recruiting
Çanakkale, Turkey, 17100
Contact: Alper Mengi, M.D.    +90 537 651 03 85    a_mengi22@hotmail.com   
Sponsors and Collaborators
Gaziosmanpasa Taksim Research and Education Hospital
Mehmet Akif Ersoy Canakkale State Hospital
Investigators
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Principal Investigator: Alper Mengi, M.D. Canakkale State Hospital
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Responsible Party: Alper Mengi, Medical Doctor, Physiatrist, Gaziosmanpasa Taksim Research and Education Hospital
ClinicalTrials.gov Identifier: NCT04248478    
Other Study ID Numbers: KAEK-27/2020-2000006994
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alper Mengi, Gaziosmanpasa Taksim Research and Education Hospital:
Chronic Pain
Eating Habits
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases