NCT03394898

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

1.8 years

First QC Date

January 3, 2018

Last Update Submit

July 29, 2019

Conditions

Eating BehaviorBody WeightFibromyalgia

Keywords

Chronic PainBody Mass IndexEating Habits

Outcome Measures

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.

    7 days

Secondary Outcomes (3)

  • activities of daily living

    7 days

  • calf circumference

    1 day

  • body mass index

    1 day

Interventions

body mass index, eating behaviourOTHER

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.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBeing a female between the ages of 18-40
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects who applied to the Physical Medicine and Rehabilitation outpatient clinic

You may qualify if:

  • Female subjects between the ages of 18-40
  • Subjects, who met the 2013 American College of Rheumatology (ACR) criteria for Fibromyalgia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Taksim Research and Education Hospital

Istanbul, 34255, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21972124BACKGROUND

MeSH Terms

Conditions

Feeding BehaviorBody WeightFibromyalgiaChronic Pain

Interventions

Body Mass Index

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic Manifestations

Intervention Hierarchy (Ancestors)

Body Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisAnthropometryInvestigative TechniquesPhysiological PhenomenaBiometryEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • alper MENGİ, M.D.

    Gaziosmanpasa Taksim Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ömer Necati Develioglu, M.D.

CONTACT

+90 212 945 30 00taksimetikkurul@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Alper Mengi, M.D.

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 9, 2018

Study Start

January 3, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)