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Status unknownNCT03394898Updated Jul 30, 2019

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

An observational study in Eating Behavior, Body Weight and Fibromyalgia, sponsored by Gaziosmanpasa Research and Education Hospital. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by Gaziosmanpasa Research and Education Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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 .

02

Conditions studied

  • Eating Behavior
  • Body Weight
  • Fibromyalgia

Keywords

  • Chronic Pain
  • Body Mass Index
  • Eating Habits
03

In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's planned enrollment of 100 is below the median of 183 across 270 observational studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

Gaziosmanpasa Research and Education Hospital is the lead sponsor of 126 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects who applied to the Physical Medicine and Rehabilitation outpatient clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
4 Weeks
Patient registry
Yes

Interventions

  • Otherbody 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 days

Secondary outcomes

  1. 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.

    Time frame: 7 days

  2. calf circumference

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

    Time frame: 1 day

  3. body mass index

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

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Gaziosmanpasa Taksim Research and Education Hospital
    Istanbul, 34255, Turkey
    Recruiting
08

References and documents

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. PubMed 21972124 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2018 (actual). Primary completion is estimated for Nov 2019, 21 months after the start.

Of 100 non-industry observational studies under Feeding Behavior, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 62. This study's planned 21 months is below that.

Counting every sponsor, half of 101 studies reached it within 24 months; a quarter within 8 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 3, 2018
First posted
Jan 9, 2018
StartActual
Jan 3, 2018
Primary completionEst.
Nov 1, 2019
CompletionEst.
Nov 1, 2019
Last update
Jul 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03394898
Responsible party
Alper Mengi (Alper Mengi, M.D., Gaziosmanpasa Research and Education Hospital) — Principal investigator
First posted
Jan 9, 2018
Start date
Jan 3, 2018
Primary completion
Nov 1, 2019 (estimated)
Completion
Nov 1, 2019 (estimated)
Last update
Jul 30, 2019

Study contacts

Ömer Necati Develioglu, M.D.
Contact
taksimetikkurul@gmail.com
+90 212 945 30 00
alper MENGİ, M.D.
principal investigator · Gaziosmanpasa Taksim Training and Research Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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