Eating Behaviours in Female Patients With Fibromyalgia

Sponsor
Gaziosmanpasa Research and Education Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04248478
Collaborator
Mehmet Akif Ersoy Canakkale State Hospital (Other)
110
1
4.1
27

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated 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 :
Jan 29, 2020
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. eating behaviour [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 [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 [1 day]

    The participants' weights and heights will be measured and the body mass index will be calculated from the measured values.

  3. sex [1 day]

    It will be registered as male or female.

  4. age [1 day]

    The age of the participant will be recorded.

  5. level of education [1 day]

    The education status will be recorded as not literate, primary school, secondary school, high school or university.

  6. job [1 day]

    The job will be recorded as unemployed, housewife, office worker or heavy duty worker.

  7. socio-economic situation [1 day]

    Socio-economic situation will be recorded as income less than expense, income equal to expense or income lower than expense.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alper Mengi Çanakkale Turkey 17100

Sponsors and Collaborators

  • Gaziosmanpasa Research and Education Hospital
  • Mehmet Akif Ersoy Canakkale State Hospital

Investigators

  • Principal Investigator: Alper Mengi, M.D., Canakkale State Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alper Mengi, Medical Doctor, Physiatrist, Gaziosmanpasa Research and Education Hospital
ClinicalTrials.gov Identifier:
NCT04248478
Other Study ID Numbers:
  • KAEK-27/2020-2000006994
First Posted:
Jan 30, 2020
Last Update Posted:
May 5, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alper Mengi, Medical Doctor, Physiatrist, Gaziosmanpasa Research and Education Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2020