Women's Health Food Frequency Questionnaire

Diet Habit Clinical Trial

Official title:

Developing A Food Frequency Questionnaire To Evaluate Women's Dietary Iron, Folate, and Vitamin B12 Intake Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05843942
• Other study ID #: GO 22/867
• Status: Completed
• Start date: January 5, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: March 30, 2024
• Est. primary completion date: December 30, 2023
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Habit

Intervention

Other:
• Questionnaire
A food frequency questionnaire that was designed to assess folate, iron, and vitamin B12 intake will be administered. Furthermore a 24-hour recall food record will be administered and a complete blood count will be collected. Food frequency questionnaire data will be compared to recall food records and blood count data.

Locations

Country	Name	City	State
Turkey	Hacettepe University Family Medicine Department Student Health Center	Ankara
Turkey	Hacettepe University Nutrition and Dietetics Department	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron intake	Dietary iron intake levels collected from both food frequency questionnaire and 24-hour recall food records	12 months
Primary	Folate intake	Dietary folate intake levels collected from both food frequency questionnaire and 24-hour recall food records	12 months
Primary	Vitamin B12 intake	Dietary vitamin B12 intake levels collected from both food frequency questionnaire and 24-hour recall food records	12 months