Diet HabitNCT05843942
Women's Health Food Frequency Questionnaire
An observational study of Diet Habit, run by Hacettepe University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Diet Habit
- What is being tested?
- Questionnaire
- How many people
- 450 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Jan 2023to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Women only
- Adult
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.
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hacettepe University Family Medicine Department Student Health Center
Ankara, 06100
Hacettepe University Nutrition and Dietetics Department
Ankara, 06100
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet Habit
- Being tested
- Questionnaire
- Keywords
- women's health, folate intake, iron intake, vitamin B12 intake
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron intake
Dietary iron intake levels collected from both food frequency questionnaire and 24-hour recall food records
Measured: 12 months
Folate intake
Dietary folate intake levels collected from both food frequency questionnaire and 24-hour recall food records
Measured: 12 months
Vitamin B12 intake
Dietary vitamin B12 intake levels collected from both food frequency questionnaire and 24-hour recall food records
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start5 Jan 2023
- Primary completion30 Dec 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Goktas, Hacettepe University
- Investigators
- Zeynep Goktas, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843942
- Sponsor's protocol ID
- GO 22/867
- Status last verified
- May 2024
- First submitted
- 25 Apr 2023
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are not publicly available due to privacy or ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing A Food Frequency Questionnaire To Evaluate Women's Dietary Iron, Folate, and Vitamin B12 Intake Status
- ClinicalTrials.gov ID
- NCT05843942
- Acronym / sponsor ID
- GO 22/867
- Conditions
- Diet Habit
- Keywords
- women's health, folate intake, iron intake, vitamin B12 intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-pregnant women of reproductive age | – | Other: QuestionnaireIn 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. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- Female sex
- Between the ages of 19-50
- Of reproductive age
- Not pregnant
- Menstruating
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireA 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. | Other | Non-pregnant women of reproductive age |
Primary outcome
Iron intake
Time frame: 12 months
Dietary iron intake levels collected from both food frequency questionnaire and 24-hour recall food records
Folate intake
Time frame: 12 months
Dietary folate intake levels collected from both food frequency questionnaire and 24-hour recall food records
Vitamin B12 intake
Time frame: 12 months
Dietary vitamin B12 intake levels collected from both food frequency questionnaire and 24-hour recall food records
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No. The data are not publicly available due to privacy or ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Goktas, PhD principal investigator
Hacettepe University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Habit, run by Hacettepe University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron intake (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.