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Completed

NCT Number: NCT05843942

Women's Health Food Frequency Questionnaire

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.

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Key information

Age range

19 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Hacettepe University Family Medicine Department Student Health Center, Ankara, Turkey (Türkiye)

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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.

Primary outcomes

  1. Iron intake

    Time frame: 12 months

    Dietary iron intake levels collected from both food frequency questionnaire and 24-hour recall food records

  2. Folate intake

    Time frame: 12 months

    Dietary folate intake levels collected from both food frequency questionnaire and 24-hour recall food records

  3. Vitamin B12 intake

    Time frame: 12 months

    Dietary vitamin B12 intake levels collected from both food frequency questionnaire and 24-hour recall food records

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 6, 2023
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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