Women's Health Food Frequency Questionnaire

Sponsor
Hacettepe University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05843942
Collaborator
(none)
350
2
14.8
175
11.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Developing A Food Frequency Questionnaire To Evaluate Women's Dietary Iron, Folate, and Vitamin B12 Intake Status
Actual Study Start Date :
Jan 5, 2023
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Iron intake [12 months]

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

  2. Folate intake [12 months]

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

  3. Vitamin B12 intake [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 50 Years
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Family Medicine Department Student Health Center Ankara Turkey 06100
2 Hacettepe University Nutrition and Dietetics Department Ankara Turkey 06100

Sponsors and Collaborators

  • Hacettepe University

Investigators

  • Principal Investigator: Zeynep Goktas, PhD, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeynep Goktas, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier:
NCT05843942
Other Study ID Numbers:
  • GO 22/867
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zeynep Goktas, Principal Investigator, Hacettepe University

Study Results

No Results Posted as of May 6, 2023