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Evaluation of Body Mass Index and Eating Behaviour Changes in Female Patients With Fibromyalgia Under Medical Treatment

Sponsor
Gaziosmanpasa Research and Education Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03394898
Collaborator
(none)
100
Enrollment
1
Location
21.9
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate of body mass index and eating behaviour changes in female patients with fibromyalgia under medical treatment.

Condition or Disease Intervention/Treatment Phase
  • Other: body mass index, eating behaviour

Detailed Description

The female patients with fibromyalgia under medical treatment say that body mass index and eating behaviour changes,for this reason, this relationship will be investigated in this study.

Demographic data (sex, age, education level, occupation) of patients with fibromyalgia diagnosis will be questioned and height lengths will be measured. The group of medications (serotonin and norepinephrine reuptake inhibitor or GABAergic drugs) that begins with the diagnosis of the disease fibromyalgia will be recorded.

All patients will be assessed when diagnosed, followed by 2nd week and then 4nd week.

In each follow-up, the patients' weights will be measured again (the body mass index will be calculated from the measured value).

In each follow-up, 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.

In each follow-up, 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.

In each follow-up, the right calf circumference of the patients will be measured in centimeters with a tape measure .

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective, Observational Study of Evaluation of Body Mass Index and Eating Behaviour Changes in Female Patients With Fibromyalgia Under Medical Treatment
Actual Study Start Date :
Jan 3, 2018
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Nov 1, 2019

Outcome Measures

Primary Outcome Measures

  1. eating behaviour [7 days]

    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.

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 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.

  2. calf circumference [1 day]

    The right calf circumference of the patients will be measured in centimeters with a tape measure .

  3. body mass index [1 day]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Female subjects between the ages of 18-40

  • Subjects, who met the 2013 American College of Rheumatology (ACR) criteria for Fibromyalgia

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 Gaziosmanpasa Taksim Research and Education Hospital Istanbul Turkey 34255

Sponsors and Collaborators

  • Gaziosmanpasa Research and Education Hospital

Investigators

  • Principal Investigator: alper MENGİ, M.D., Gaziosmanpasa Taksim Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alper Mengi, Alper Mengi, M.D., Gaziosmanpasa Research and Education Hospital
ClinicalTrials.gov Identifier:
NCT03394898
Other Study ID Numbers:
  • 27.12.2017/108
First Posted:
Jan 9, 2018
Last Update Posted:
Jul 30, 2019
Last Verified:
Jul 1, 2019
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, Alper Mengi, M.D., Gaziosmanpasa Research and Education Hospital
Chronic Pain
Body Mass Index
Eating Habits
Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Body Weight

Study Results

No Results Posted as of Jul 30, 2019