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

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ClinicalTrials.gov Identifier: NCT03394898
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Alper Mengi, Gaziosmanpasa Taksim Research and Education Hospital

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
Eating Behavior Body Weight Fibromyalgia 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 .


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
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 : January 3, 2018
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia


Intervention Details:
  • Other: body mass index, eating behaviour
    The patients' weights and heights will be measured and the body mass index will be calculated from the measured values.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 ]
    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 [ 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 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 [ Time Frame: 1 day ]
    The right calf circumference of the patients will be measured in centimeters with a tape measure .

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Being a female between the ages of 18-40
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who applied to the Physical Medicine and Rehabilitation outpatient clinic
Criteria

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

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): NCT03394898


Contacts
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Contact: Ömer Necati Develioglu, M.D. +90 212 945 30 00 taksimetikkurul@gmail.com

Locations
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Turkey
Gaziosmanpasa Taksim Research and Education Hospital Recruiting
Istanbul, Turkey, 34255
Contact: Ömer Necati Develioğlu, MD    +90 212 945 30 00    taksimetikkurul@gmail.com   
Sponsors and Collaborators
Gaziosmanpasa Taksim Research and Education Hospital
Investigators
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Principal Investigator: alper MENGİ, M.D. Gaziosmanpasa Taksim Training and Research Hospital, Department of Physical Medicine and Rehabilitation, Gaziosmanpasa, Istanbul, Turkey

Additional Information:

Publications:
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Responsible Party: Alper Mengi, Alper Mengi, M.D., Gaziosmanpasa Taksim Research and Education Hospital
ClinicalTrials.gov Identifier: NCT03394898     History of Changes
Other Study ID Numbers: 27.12.2017/108
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
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
Body Mass Index
Eating Habits

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Body Weight
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms