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

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

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

Study Overview

• Status: Unknown
• Conditions: Body Weight; Fibromyalgia; Eating Behavior
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34255
    • Recruiting
    • Gaziosmanpasa Taksim Research and Education Hospital
    • Contact: Ömer Necati Develioğlu, MD; Phone Number: +90 212 945 30 00; Email: taksimetikkurul@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Subjects who applied to the Physical Medicine and Rehabilitation outpatient clinic

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eating behaviour	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
activities of daily living	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.	7 days
calf circumference	The right calf circumference of the patients will be measured in centimeters with a tape measure .	1 day
body mass index	The patients' weights and heights will be measured and the body mass index will be calculated from the measured values.	1 day

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Chronic Pain; Body Mass Index; Eating Habits
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Body Weight; Myofascial Pain Syndromes
• Other Study ID Numbers: 27.12.2017/108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No