Clinical trial NCT05843942: Women's Health Food Frequency Questionnaire
Official title: Developing A Food Frequency Questionnaire To Evaluate Women's Dietary Iron, Folate, and Vitamin B12 Intake Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet Habit
Keywords: women's health
folate intake
iron intake
vitamin B12 intake
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 450
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The sample of the study will consist of 350 non-pregnant (menstruating) volunteer women between the ages of 18-50 of reproductive age. The required sample size was calculated as 323 women via power analysis with a predicted 0.50 kappa agreement value, %5 type I error, and %95 confidence level. Subjects who meet the inclusion criteria of the study will be recruited among women that apply to the Hacettepe University Family Medicine Department Student Health Center.

Brief summary: The aim of this study is to develop a tool that can measure the iron, folate, and vitamin B12 content of a diet through a literature review, database search, and a pilot study using a food consumption record. This tool will be used to accurately evaluate the iron, folate, and vitamin B12 content of the diet in non-pregnant women of reproductive age who are not currently pregnant. The research will be conducted on 350 women between the ages of 18 and 50 who are of reproductive age (menstruating). A questionnaire will be administered to the volunteer participants, which will consist of sections on general information, dietary habits, frequency of food consumption, and a 24-hour dietary recall.

Detailed description: The study is planned in three stages. In the first stage, a three-day food consumption record will be taken from 50 non-pregnant (menstruating) women of reproductive age in order to determine the foods to be included in the food consumption frequency section, and the questionnaire sections and questions (nutrition habits and food consumption frequency questionnaire) will be designed. In the second stage of the study, the questionnaire developed in the first stage will be applied to 350 non-pregnant (menstruating) volunteer women of reproductive age through face-to-face interviews. In this stage, the blood parameters of at least 100 individuals whose blood counts have already been taken for routine tests and treatments and who meet the inclusion criteria of the study will also be recorded from their patient files. In the third stage, the questionnaire will be applied again to 75 individuals who have completed the second stage at least 2 weeks later in order to evaluate the reliability of the questionnaire.

Eligibility criteria: Inclusion Criteria:

* Female sex
* Between the ages of 19-50
* Of reproductive age
* Not pregnant
* Menstruating
* Not having a disease that affects nutrition
* Not following a special diet (weight loss diet, etc.)

Exclusion Criteria:

* Male sex
* Under 19 or over 50 years of age
* Having a disease that affects nutrition
* Following a special diet (gluten-free diet, etc.)
* Making changes in diet for the purpose of weight loss
* Of reproductive age but not menstruating

Primary outcomes:
measure: Iron intake
timeFrame: 12 months
measure: Folate intake
timeFrame: 12 months
measure: Vitamin B12 intake
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Family Medicine Department Student Health Center
city: Ankara
country: Turkey
facility: Hacettepe University Nutrition and Dietetics Department
Study officials:
affiliation: Hacettepe University
name: Zeynep Goktas, PhD
role: PRINCIPAL_INVESTIGATOR
References: