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

NCT ID: NCT03394898

Last Updated: 2019-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-03

Study Completion Date

2019-11-01

Brief Summary

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

Detailed Description

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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 .

Conditions

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Eating Behavior Body Weight Fibromyalgia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gaziosmanpasa Research and Education Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Alper Mengi

Alper Mengi, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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alper MENGİ, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gaziosmanpasa Taksim Training and Research Hospital

Locations

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Gaziosmanpasa Taksim Research and Education Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ömer Necati Develioglu, M.D.

Role: CONTACT

+90 212 945 30 00

Facility Contacts

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Ömer Necati Develioğlu, MD

Role: primary

+90 212 945 30 00

References

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Kim CH, Luedtke CA, Vincent A, Thompson JM, Oh TH. Association of body mass index with symptom severity and quality of life in patients with fibromyalgia. Arthritis Care Res (Hoboken). 2012 Feb;64(2):222-8. doi: 10.1002/acr.20653.

Reference Type BACKGROUND
PMID: 21972124 (View on PubMed)

Other Identifiers

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27.12.2017/108

Identifier Type: -

Identifier Source: org_study_id

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