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

Sponsor

University Ghent (Other)

Overall Status

Recruiting

CT.gov ID

NCT06094023

Collaborator

Arba Minch University (Other), Institut de Recherche en Sciences de la Sante, Burkina Faso (Other), Addis Ababa University (Other)

120

Enrollment

Location

10.8

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dietary Assessment	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 6, 2023

Anticipated Primary Completion Date :

Jul 30, 2024

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

1. Mean/Median proportion of folic acid intake assessed by the 24 hour recalls [12 month]
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
2. Mean/median proportion of folic acid intake assessed by the food frequency questionnaire [12 month]
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
3. Mean/median proportion of vitamin B12 intake assessed by the 24 hour recalls [12 month]
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
4. Mean/median proportion of vitamin B12 intake assessed by the food frequency questionnaire [12 month]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 19 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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