Eating BehaviorNCT04248478
Eating Behaviours in Female Patients With Fibromyalgia
An observational study of Eating Behavior and Fibromyalgia, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The Relationship Between Eating Behaviours and Health Status of Female Patients with Fibromyalgia Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Fibromyalgia, Health Status
- What is being tested?
- Eating Behaviours and Health Status
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jan 2020to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients diagnosed with fibromyalgia and healthy volunteers are planned to be included in the study.
Who may be able to join
- Female patients between the ages of 18-40
- Patients diagnosing fibromyalgia for the first time according by 2013 American College of Rheumatology (ACR) criteria
Who cannot join
- 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
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- Uncooperative subject
- History of cardiac pathology such as heart failure, coronary artery disease
- History of diabetes, chronic renal insufficiency, chronic liver failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Alper Mengi
Çanakkale, 17100
Alper Mengi, M.D., +90 537 651 03 85, a_mengi22@hotmail.com
About this study
Official title: The Relationship Between Eating Behaviours and Health Status of Female Patients With Fibromyalgia
The Relationship Between Eating Behaviours and Health Status of Female Patients with Fibromyalgia
Read the detailed description
The purpose of this study is to evaluate the nutritional behaviours of female patients with fibromyalgia according to the healthy population and the relationship of these behaviours with the current health status of the patient.
In the investigatgor's clinical practice, eating-related problems (increased or decreased appetite, uncontrolled eating, etc.) are observed in fibromyalgia patients. In this study, it will be investigated whether this situation is different from healthy population and whether it is related with the healt status.
Patients diagnosed with fibromyalgia according to 2013 American College of Rheumatology criteria and healthy volunteers are planned to be included in the study.
Demographic data (sex, age, level of education, job, socio-economic situation) will be questioned and their body mass indexes (BMI) will be calculated from all participitants All participants' eating behaviour will be questioned with Three Factor Eating Questionnaire.
In fibromyalgia patients, effect of fibromyalgia on the daily life of the patients will be questioned with Fibromyalgia Impact Questionnaire.
- Conditions
- Eating Behavior, Fibromyalgia, Health Status
- Being tested
- Eating Behaviours, Health Status
- Keywords
- Chronic Pain, Eating Habits
- Medical subject headings
- Feeding Behavior, Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating BehavioursOther
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.
Health StatusOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fibromiyalgia Patients | Patients diagnosed with fibromyalgia according to 2013 American College of Rheumatology criteria are planned to be included in this arm. Receives: Other: Eating Behaviours; Other: Health Status | |
| Healthy Volunteers | Healthy volunteers are planned to be included in this arm. Receives: Other: Eating Behaviours |
What is being measured
The primary outcome is the main question the study is designed to answer.
eating behaviour
Participants' eating behaviour will be questioned with Three Factor Eating Questionnaire (TFEQ). The TFEQ contains 51 items (questions) and measures three dimensions of human eating behavior 'cognitive restraint of eating' (Factor I - 21 items) 'disinhibition' (Factor II - 16 items) 'hunger' (Factor III - 14 items). Each item scores either 0 or 1 point. The minimum score for factors I-II-III is therefore 0-0-0, the possible maximum score 21-16-14.
Measured: 7 days
Secondary outcomes (7)
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 10 items (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. The maximum possible score of each subtitle is 10. Thus, the total maximum score is 100, a lower score indicates better quality of life.
Measured: 7 days
body mass index
The participants' weights and heights will be measured and the body mass index will be calculated from the measured values.
Measured: 1 day
sex
It will be registered as male or female.
Measured: 1 day
age
The age of the participant will be recorded.
Measured: 1 day
level of education
The education status will be recorded as not literate, primary school, secondary school, high school or university.
Measured: 1 day
job
The job will be recorded as unemployed, housewife, office worker or heavy duty worker.
Measured: 1 day
socio-economic situation
Socio-economic situation will be recorded as income less than expense, income equal to expense or income lower than expense.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start29 Jan 2020
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Collaborators
- Mehmet Akif Ersoy Canakkale State Hospital
- Responsible party
- Principal investigator, Alper Mengi, Gaziosmanpasa Research and Education Hospital
- Investigators
- Alper Mengi, M.D., Principal investigator, Canakkale State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248478
- Sponsor's protocol ID
- KAEK-27/2020-2000006994
- Status last verified
- May 2020
- First submitted
- 28 Jan 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Eating Behaviours and Health Status of Female Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT04248478
- Acronym / sponsor ID
- KAEK-27/2020-2000006994
- Conditions
- Eating Behavior, Fibromyalgia, Health Status
- Keywords
- Chronic Pain, Eating Habits
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Collaborators
- Mehmet Akif Ersoy Canakkale State Hospital
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Relationship Between Eating Behaviours and Health Status of Female Patients with Fibromyalgia
Detailed description
The purpose of this study is to evaluate the nutritional behaviours of female patients with fibromyalgia according to the healthy population and the relationship of these behaviours with the current health status of the patient.
In the investigatgor's clinical practice, eating-related problems (increased or decreased appetite, uncontrolled eating, etc.) are observed in fibromyalgia patients. In this study, it will be investigated whether this situation is different from healthy population and whether it is related with the healt status.
Patients diagnosed with fibromyalgia according to 2013 American College of Rheumatology criteria and healthy volunteers are planned to be included in the study.
Demographic data (sex, age, level of education, job, socio-economic situation) will be questioned and their body mass indexes (BMI) will be calculated from all participitants All participants' eating behaviour will be questioned with Three Factor Eating Questionnaire.
In fibromyalgia patients, effect of fibromyalgia on the daily life of the patients will be questioned with Fibromyalgia Impact Questionnaire.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromiyalgia Patients | – | Other: Eating Behaviours, Other: Health StatusPatients diagnosed with fibromyalgia according to 2013 American College of Rheumatology criteria are planned to be included in this arm. |
| Healthy Volunteers | – | Other: Eating BehavioursHealthy volunteers are planned to be included in this arm. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with fibromyalgia and healthy volunteers are planned to be included in the study.
Key inclusion criteria (2 listed)
- Female patients between the ages of 18-40
- Patients diagnosing fibromyalgia for the first time according by 2013 American College of Rheumatology (ACR) criteria
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eating BehavioursPatients' 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. | Other | Fibromiyalgia Patients, Healthy Volunteers |
| Health StatusThe 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. | Other | Fibromiyalgia Patients |
Primary outcome
eating behaviour
Time frame: 7 days
Participants' eating behaviour will be questioned with Three Factor Eating Questionnaire (TFEQ). The TFEQ contains 51 items (questions) and measures three dimensions of human eating behavior 'cognitive restraint of eating' (Factor I - 21 items) 'disinhibition' (Factor II - 16 items) 'hunger' (Factor III - 14 items). Each item scores either 0 or 1 point. The minimum score for factors I-II-III is therefore 0-0-0, the possible maximum score 21-16-14.
7 secondary outcomes
activities of daily living
Time frame: 7 days
body mass index
Time frame: 1 day
sex
Time frame: 1 day
age
Time frame: 1 day
level of education
Time frame: 1 day
job
Time frame: 1 day
socio-economic situation
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alper Mengi, M.D. principal investigator
Canakkale State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Behavior and Fibromyalgia, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alper Mengi, M.D. (+90 5376510385, a_mengi22@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eating behaviour (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.