The Effect of Menstruation on Food Preference and Balance
1 other identifier
observational
60
1 country
1
Brief Summary
Menstruation period, which is accepted as the symbol of fertility, and some problems related to this process covers half of a woman's life. During this period, various changes occur in the female body, especially in the endocrine system. These changes in the menstrual cycle can affect women physiologically and psychologically.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2023
CompletedFirst Posted
Study publicly available on registry
April 20, 2023
CompletedStudy Start
First participant enrolled
April 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2023
CompletedApril 25, 2023
April 1, 2023
1 month
April 6, 2023
April 23, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
star excursion balance test
On the previously prepared platform; There are 8 linear lines that form a star shape, arranged at an angle of 45 degrees between them. Before the test was administered to the individuals, necessary explanations were made and they were informed about the test. The individual to be tested was positioned to coincide with the very center of this shape. The untested leg was used to maintain the stability of the body in full contact with the ground. The tested leg, on the other hand, was asked to extend maximum in different directions and return to the starting position.
one month
Food Record
Food records were evaluated in the "Nutrition Determine" program, and each participant received) amounts were calculated. Selections and intakes of nutrients will be evaluated. The Three-Factor Eating Questionnaire-Revised 18 Items (TFEQ-R18) consists of 18 items ona 4-point Likert scale (1 = definitely true, 2 = mostly true, 3 = mostly false, 4 = definitely false).Responses to each of the 18 items are summated into scale scores for cognitive restraint, uncontrolledeating, and emotional eating .igher scores in the respective scales areindicative of greater cognitive restraint, uncontrolled, or emotional eating.
one month
General Anxiety Disorder
It is a test that evaluates the anxiety disorder of individuals with a short and self-reported way. It questions the emotions and mood changes experienced by individuals in the last 2 weeks. Each question of this test, which consists of 7 questions, has a 4-point Likert option. According to the scores obtained from the scale; 5,10,15 are used as cutoff points for mild, moderate and severe anxiety, respectively. In individuals with a total score of 10 and above, their anxiety should be investigated and confirmed by other methods. Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety.
one month
One Leg Standing Test
Before starting the test, the desired position was shown to the individuals and it will be explained in which cases the test will be invalid. This test was planned to be performed on both the right and left legs of the individuals. The desired position is for the untested leg; hip and leg flexed to 90 degrees, arms free, and the tested leg in full extension.
one month
Premenstrual Syndrome Scale
Before answering the questions, individuals will be asked to think about the 7 days before menstruation. The scale consists of 44 questions in five-point Likert type.The lowest score is 44, and 220 is the highest. If the score (\> 132)it will considered a positive Premenstrual Syndrome and as the score gets higher then indicate greater severity of symptoms during Premenstrual Syndrome .
one month
Secondary Outcomes (2)
Three Factor Nutrition Questionnaire
one month
Physical Activity Questionnaire
one month
Study Arms (2)
Premenstrual period
For the premenstrual period evaluation, the participants' 10 days before menstruation will be taken as a reference.
Menstrual period
For the evaluation of the menstrual period, the first 3 days when symptoms are seen more will be taken as a reference.
Eligibility Criteria
The study will be conducted using qualitative data with a total of 60 women in the 18-45 age group living in Turkey within 3 months following the ethics committee approval.
You may qualify if:
- Having completed the age of 18,
- Not over 45 years old and not in menopause,
- Not having any diagnosed psychological disease,
You may not qualify if:
- Individuals who menstruate with medical treatment every month,
- Individuals with lower extremity disability,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HAZAL genç
Istanbul, 34070, Turkey (Türkiye)
Related Publications (1)
Souza LB, Martins KA, Cordeiro MM, Rodrigues YS, Rafacho BPM, Bomfim RA. Do Food Intake and Food Cravings Change during the Menstrual Cycle of Young Women? Rev Bras Ginecol Obstet. 2018 Nov;40(11):686-692. doi: 10.1055/s-0038-1675831. Epub 2018 Nov 28.
PMID: 30485899BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 6, 2023
First Posted
April 20, 2023
Study Start
April 23, 2023
Primary Completion
May 24, 2023
Study Completion
July 21, 2023
Last Updated
April 25, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share