Women's Health Food Frequency Questionnaire

NCT05843942 | Completed

• 1 other identifier: GO 22/867
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 2

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.

Conditions

Diet Habit

Keywords

women's health; folate intake; iron intake; vitamin B12 intake

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

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.

Non-pregnant women of reproductive age

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (2)

Hacettepe University Family Medicine Department Student Health Center

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe University Nutrition and Dietetics Department

Ankara, 06100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Feeding Behavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Zeynep Goktas, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: January 5, 2023
• Primary Completion: December 30, 2023
• Study Completion: March 30, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)