Dietary Intake of Folic Acid and Vitamin B12 Among Teenage Girls - Validation of Food Frequency Questionnaire

Development and Validation of Food Frequency Questionnaire to Assess the Dietary Intake of Folic Acid and Vitamin B12 Among Teenage Girls in South Ethiopia.

Folate and vitamin B12 deficiencies are associated with various health issues, including anemia, cardiovascular disease, depression, and birth defects. Accurate and objective estimates of dietary intake are necessary to assess any effects of nutritional status in epidemiologic studies. This study aims to develop and validate a three-month semi-quantitative food frequency questionnaire for the assessment of dietary intake of folic acid and vitamin B12, against four*two multiple-pass 24-hr dietary recall among teenage girls in South Ethiopia

Study Overview

• Status: Recruiting
• Conditions: Dietary Assessment
• Intervention / Treatment: Other: Food Frequency Questionnaire; Other: 24 Hour food recall

Detailed Description

Folic acid and vitamin B12 play an interdependent role in key cellular processes, namely deoxyribonucleic acid synthesis, cell division, red blood cell formation, and nervous system myelination. Folic acid is an essential nutrient in the growth and development of the cerebral cortex. It promotes the thickness of the cerebral cortex; which is directly proportional to the intelligence quotient, the neurocognitive and psychological development of the child. Both folate and vitamin B12 participate in the conversion of homocysteine to methionine, such that a deficiency in either vitamin will result in elevated serum concentrations of homocysteine where high levels of serum homocysteine are associated with an increased risk for depression. Deficiencies in folate and vitamin B12 have been shown to delay growth spurt and pubertal growth during adolescence. Some studies also showed that there is an association between overweight and obesity with lower serum vitamin B12 and folate levels.

In research, there are several challenges in the accurate assessment of diet and nutrition. In the Ethiopian context, there is no tool that specifically assesses dietary intake of folic acid and vitamin B12 in adolescents. In this project, reliable dietary assessment tools for assessing dietary intake of folic acid and vitamin B12 will be developed and validated for future use as an unbiased reference measure. The dietary validation study will start by conducting a food frequency questionnaire (FFQ). The FFQ will consider the recall time frame of the previous three months assuming that the consumption patterns for folate and vitamin B12-rich foods of participants over a three-month period can be considered as their usual food intake. The FFQ will be administered to the selected study participants four times: at the beginning of the validation study, after 3 and 6 months, and at 9 months (the end of the study). The same participants will be also asked to complete two 24-hour food recalls every three months in a nine-month period. The first 24-hour recall questionnaires will be collected at least one week after the first FFQ, and one within the 3-month period considering one weekday and one weekend day. A total of eight 24-hour food recalls and four FFQs will be collected.

Study objective

The objective of this sub study is to develop and validate a FFQ that can be used to assess the dietary intake of folic acid and vitamin B12 among teenage girls who reside in rural communities of Arba Minch Health and Demographic Surveillance Sites (AM-HDSS), South Ethiopia.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Souheila Abbeddou, MSc. PhD; Phone Number: +32467630892; Email: Souheila.Abbeddou@UGent.Be
• Study Contact Backup: Name: Muluken Bekele Sorrie, MPH; Phone Number: +251920256806; Email: mulukenbekele.sorrie@ugent.be

Study Locations

• Ethiopia
  • Arba Minch, Ethiopia
    • Recruiting
    • Arba Minch University
    • Sub-Investigator: Jerome W Some, MD. PhD
    • Sub-Investigator: Gudina Egata, PhD
    • Contact: Muluken Bekele Sorrie, MPH; Email: Muluken Bekele Sorrie <MulukenBekele.Sorrie@UGent.be>
    • Contact: Eshetu Zerihun Tariku, MPH; Email: Eshetu Zerihun Tariku <EshetuZerihun.Tariku@UGent.be>

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study will be conducted among randomly selected teenage girls between the age of 13-19 years who resides in households at AM-HDSS. The data collection will be done at the selected teenagers' households.

Description

Inclusion Criteria:

• One or both of their parents signed an informed consent form and the girls agreed.
• Their parents and the girl planned to stay during the period of the study (minimum 9 months) in the kebele.
• Aged between 13 and 19 years
• Familiar with the diet and cooking practices
• Accept enumerators for home visit and data collection for one year

Exclusion Criteria:

• Teenage girls who are pregnant and/or are lactating

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Teenage girls between 13 and 19 years living in the Arba Minch Demographic and Surveillance site.; Participants in this study should be acquainted with cooking practices to be able to cite all the ingredients that are used in the preparation of the dishes/ meals	Other: Food Frequency Questionnaire; Food frequency questionnaires (FFQs) are a common method for measuring dietary intake in large epidemiological studies, in particular in low literacy settings were diaries and food history would not be viable.; Other: 24 Hour food recall; Standardized and validated approach of collecting all foods, beverages, and supplements consumed during the past 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Mean/Median proportion of folic acid intake assessed by the 24 hour recalls	Mean/Median proportion of folic acid intake from (Cereal and cereal products, Tubers & Roots, Legumes & Legume products, Vegetables, Fruit & Berries, Meat & Poultry, Fish, Dairy products, Egg, Sugars, Oil, Fat, Oil seeds & nuts, Herbs & spices , soft drinks and beverages) assessed by 24 hour recalls The recommended intake for folic acid for teenage girls aged between 13 and 19 years is set at 400 micrograms/day	12 month
2. Mean/median proportion of folic acid intake assessed by the food frequency questionnaire	Mean/Median proportion of folic acid intake from (Cereal and cereal products, Tubers & Roots, Legumes & Legume products, Vegetables, Fruit & Berries, Meat & Poultry, Fish, Dairy products, Egg, Sugars, Oil, Fat, Oil seeds & nuts, Herbs & spices , soft drinks and beverages) assessed by food frequency questionnaire. The recommended intake for folic acid for teenage girls aged between 13 and 19 years is set at 400 micrograms/day	12 month
3. Mean/median proportion of vitamin B12 intake assessed by the 24 hour recalls	Mean/Median proportion of vitamin B12 intake from (Meat & Poultry, Fish, Dairy products, Egg, soft drinks and beverages) assessed by 24 hour recalls The recommended intake for vitamin B12 for teenage girls aged between 13 and 19 years is set at 2.4 micrograms/day	12 month
4. Mean/median proportion of vitamin B12 intake assessed by the food frequency questionnaire	Mean/Median proportion of vitamin B12 intake from (Meat & Poultry, Fish, Dairy products, Egg, soft drinks and beverages) assessed by food frequency questionnaire The recommended intake for vitamin B12 for teenage girls aged between 13 and 19 years is set at 2.4 micrograms/day	12 month

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Institut de Recherche en Sciences de la Sante, Burkina Faso; Addis Ababa University; Arba Minch University
• Investigators: Principal Investigator: Stefaan De Henauw, MD. PhD, University Ghent

Publications and helpful links

General Publications

• Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes and its Panel on Folate, Other B Vitamins, and Choline. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington (DC): National Academies Press (US); 1998. Available from http://www.ncbi.nlm.nih.gov/books/NBK114310/
• Beydoun MA, Shroff MR, Beydoun HA, Zonderman AB. Serum folate, vitamin B-12, and homocysteine and their association with depressive symptoms among U.S. adults. Psychosom Med. 2010 Nov;72(9):862-73. doi: 10.1097/PSY.0b013e3181f61863. Epub 2010 Sep 14.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2023
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin B12; Folic acid; Food Frequency Questionnaire; Dietary assessment; Multi-pass 24 hour food recall; Semi-quantitative
• Other Study ID Numbers: ONZ-2023-0137-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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