Eating Behaviours in Female Patients With Fibromyalgia

NCT04248478 | Unknown

• 1 other identifier: KAEK-27/2020-2000006994
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Eating Behavior; Fibromyalgia; Health Status

Keywords

Chronic Pain; Eating Habits

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• activities of daily living

  7 days

• body mass index

  1 day

• sex

  1 day

• age

  1 day

• level of education

  1 day

Study Arms (2)

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; Other: Health Status

Healthy Volunteers

Healthy volunteers are planned to be included in this arm.

Other: Eating Behaviours

Interventions

Eating Behaviours OTHER

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.

Fibromiyalgia Patients; Healthy Volunteers

Health Status OTHER

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.

Fibromiyalgia Patients

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead
• Mehmet Akif Ersoy Canakkale State Hospital: collaborator

Study Sites (1)

Alper Mengi

Çanakkale, 17100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Feeding Behavior; Fibromyalgia; Chronic Pain

Interventions

Health Status

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Alper Mengi, M.D.

  Canakkale State Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alper Mengi, M.D.

CONTACT

+90 5376510385; a_mengi22@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Physiatrist

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: January 29, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)