Women's Health Food Frequency Questionnaire

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

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.

Study Overview

• Status: Completed
• Conditions: Diet Habit
• Intervention / Treatment: Other: Questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 450

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Nutrition and Dietetics Department
  • Ankara, Turkey, 06100
    • Hacettepe University Family Medicine Department Student Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Non-pregnant women of reproductive age; 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. A 24-hour recall food consumption record will be taken. 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. 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 results.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iron intake	Dietary iron intake levels collected from both food frequency questionnaire and 24-hour recall food records	12 months
Folate intake	Dietary folate intake levels collected from both food frequency questionnaire and 24-hour recall food records	12 months
Vitamin B12 intake	Dietary vitamin B12 intake levels collected from both food frequency questionnaire and 24-hour recall food records	12 months

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Zeynep Goktas, PhD, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: women's health; iron intake; folate intake; vitamin B12 intake
• Other Study ID Numbers: GO 22/867

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data are not publicly available due to privacy or ethical restrictions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No