Abstract
The food security status of pregnant women not only affects their current health status and that of their newborn, but also plays an important role in the health status of children and adults in the future. Food security is a complicated and multidimensional concept. In pregnant women, it is the result of several complex individuals, family, social, cultural, economic, and political factors such as lack of health services, gender inequality, and lack of resources. Public instruments that mainly measure food insecurity at the household level have been used to investigate the food security status of pregnant women. Therefore, we aimed to define the concept of food security based on the experience of both pregnant women and experts, and then develop and validate the assessment tool for assessing food security in pregnant women. In this article, only the protocol of this study is discussed. This research is a mixed-method study with a sequential-exploratory approach, which will be conducted in two phases. In the qualitative phase, the concepts and dimensions of food security will be explained based on the experiences of pregnant women by using inductive content analysis. Data integrity will be guaranteed with five criteria of validity, verifiability, reliability, transferability, and authenticity. In the second phase, the primary tool will be developed based on Waltz and Basel's approach, and then it will be validated. The design of a specific tool for pregnant women, taking into account the cultural, economic, and social conditions of Iran, can be a practical solution to scientifically assess the food security status of pregnant women, so that the country’s policymakers and planners can take accurate and long-term steps towards improving the food security of Iran pregnant women, their health and that of the future generations by implementing basic policies.
Background
Food insecurity has a significant impact on the physical and mental health of pregnant women, so it is an environmental risk factor for adverse pregnancy outcomes (Areba et al., 2022). Food security indicates the physical, social, and economical access of all people at all times to sufficient and healthy food, in order to meet their nutritional needs and preferences for a healthy and active life (Secretariat of the Supreme Council of Health and Food Safety of the Ministry of Health, Medicine, Medical Education [SSCHFS], 2021). On the other hand, food insecurity means limited or uncertain access to sufficient, nutritive, and healthy food, or limited ability to obtain food in socially acceptable ways (Hakim et al., 2012).
Women are the most vulnerable group in the face of household food insecurity (Pellowski et al., 2017) and studies indicate that the prevalence of severe food insecurity among women is 10% higher than that of men (Ghanbari Shirsawar, 2019). Pregnant women in food-insecure families may tend to consume low-cost, processed, high-calorie, and low-nutrient foods to increase household economical access. Consuming these high-energy foods over time may lead to increased weight and obesity, which are also risk factors for diabetes mellitus and high blood pressure in pregnancy (Agampodi et al., 2021; The Commission on Nutrition, ACC/SCN[UNSCN], 2000).
Food insecurity is accompanied by adverse perinatal outcomes including low birth weight, increased risk of congenital abnormalities (Carmichael et al., 2007; Gizaw & Gebremedhin, 2018; McKay et al., 2022; Sahlu et al., 2020) such as cleft palate, displacement of large vessels, tetralogy of Fallot and spina bifida, increased risk of transmission of immune system deficiency disease (Gillespie & Kadiyala, 2005) and childhood growth disorder (Yong et al., 2021). As a result, household food insecurity can have significant effects on the health of the fetus by affecting the quality and adequacy of the mother's nutrition during pregnancy (Moafi et al., 2018).
According to the report of the World Health Organization (WHO) and the Food and Agriculture Organization of the United States (FAO) in 2021, the rate of moderate to severe food insecurity in Iran is 42.5% (UNICEF, 2021). Also, as cited in a National Document on Improving Nutrition in Iran in 2022, in a systematic review and meta-analysis of 31 studies, 61% of mothers in Iran are food insecure (Behzadifar et al., 2016; Secretariat of the Supreme Council of Health and Food Safety of the Ministry of Health, Medicine, Medical Education [SSCHFS], 2021). The rate of food insecurity in pregnant women in Iran in 2019 was reported to be 30.9–35.1% (Dolatian et al., 2020; Sharifi et al., 2017). In the study of Hojaji and co-workers, the prevalence of food insecurity among pregnant women in Tehran was 34.8%, and according to researchers, mothers in food-insecure households are often housewives and have younger ages, lower education, and more children. They had less income, too (Hojaji et al., 2015).
Achieving food security is based on four dimensions: firstly, providing enough food to support a healthy lifestyle (availability), secondly, all people are economically and physically able to prepare food (access), thirdly, people are able to use food that has been prepared (utilization) and fourthly, how stable are the availability, access, and utilization of food (FAO, 2021). However, since food security is a complicated and multidimensional concept, its measurement and assessment have always been a serious and ongoing challenge for researchers and experts in this field, therefore, in past studies, various tools have been used, most of which have only assessed access to food security (Ashby et al., 2016; McKay et al., 2019), and there is no agreement on the best tool for measuring food security (Bastian et al., 2022).
To assess the status of food security in pregnant women, so far the same general tools that mainly measure food insecurity at the household level have been used. While studies indicate that the food insecurity of pregnant women is influenced by individual, family, social, cultural, economic, and political factors such as lack of health services, gender inequality, and lack of resources (Iqbal & Ali, 2021). Accordingly, Bastian and his colleagues (2022), in a study entitled “development of a comprehensive household food security tool for families with young children or pregnant women in high-income countries”, designed a new tool based on the conditions governing countries with increased income. Therefore, considering the importance of food insecurity for pregnant women and its consequences, the field of food insecurity of pregnant women in low and middle-income countries also needs special attention (Teh et al., 2017). Therefore, since there is no specific policy to identify these pregnant mothers in Iran’s health system, the design of a dedicated and reliable tool based on Iran’s social and cultural background seems necessary for measuring food security in pregnant women in antenatal care, so that it can be used to adopt basic strategies and interventions to improve food security in this group. Therefore, in this article, the protocol of this mixed-methods study is presented under the title of development of a food security assessment tool for pregnant women to integrate into antenatal care in the health system, and the results of the study will be presented in another article.
Objectives
The objectives of this study are as follows:
Main Objective
Development and validation of a food security assessment tool for Iranian pregnant women
The Specific Objective of the First Phase (Qualitative Study)
- Explaining the concept and dimensions of food security for pregnant women
The Specific Goals of the Second Phase (Tool Development and Validation)
- Developing the items of the food security assessment tool for pregnant women - Determining quantitative and qualitative face validity of the tool - Determining the quantitative and qualitative content validity of the tool - Determining the construct validity of the tool - Determining the reliability of the tool
Methods
Study Design
A mixed-method study with a sequential exploratory approach will be used according to the steps suggested by Creswell in two qualitative and quantitative phases (Creswell & Creswell, 2018). The mixed-method has two phases, and because of the subjectivity of the concept of food security, qualitative study is considered the most suitable method for the first phase of this research. The philosophical foundation of this research is the pragmatism approach. In this approach, the advantages of both quantitative and qualitative approaches are used in order to reach the goals of the research (Polit & Beck, 2014). In this way, high quality and rich information can be obtained to explain the concept and dimensions of food security from the experience of pregnant women. Therefore, in the first phase, data will be collected through semi-structured interviews and will be analyzed by inductive content analysis. In the first step of the second phase, the results of the first phase of the research will be used to build constructs and items of the tool, and then in the second step of the second phase, the validation of the tool will be assessed using a quantitative study (Figure 1). Study design of development and validation of food security assessment tool for pregnant women in Iran.
Several groups of people, including the main tool design group, the monitoring committee, and the stakeholders will participate in the design and validation of the food security assessment tool for pregnant women.
The main group of tool design will include a health education specialist, a nursing education specialist, a research specialist, a nutritionist, an epidemiologist, and a reproductive health doctoral candidate.
The monitoring committee will include the professors of Tarbiat Modares University, and Tehran and Shahid Beheshti Universities of Medical Sciences. The name, affiliation, and monitoring process will be announced in the final version of the designed tool.
The group of beneficiaries will include pregnant mothers, nutrition experts at health centers, food security experts from North Khorasan University of Medical Sciences, and food security experts from the Nutrition Improvement Office of the Ministry of Health, Medicine, and Medical Education of the Islamic Republic of Iran.
This study was approved by the Ethics Committee of Tarbiat Modares University, Tehran, Iran (ethics code: IR.MODARES.REC.1401.143). The details of each step are presented in the next section.
The First Phase of the Research: the Qualitative Study
In the first phase, the concept and dimensions of food security will be explained based on the experiences of pregnant women and experts, and the main items of the tool will be determined by the qualitative research method using the inductive content analysis approach.
Characteristics of the Study Population and Participants
In this research, the primary participants in the research will be selected with the purposeful sampling method, which is a suitable method for qualitative research (Hsieh & Shannon, 2005). In this method, the researcher is looking for people who are a rich source of information and have the ability to express themselves and desire to participate in the research. Sampling and data collection will continue until the information saturation level is reached, that is, when the participants do not add new data to the previous data and the previous data are repeated (Bolderston, 2012).
Method of Data Collection
Guiding Questions for Pregnant Women and Experts with Respect to the Development and Validation of Food Security Assessment Tool for Pregnant Women in Iran.
After the participant answered each of these questions, probing questions will be asked appropriately and the interviews will continue until the participants believe that they have no more information to provide. In case of fatigue or lack of data saturation of the data, the interview will continue in the next sessions with the same participant. At the end of the interview, the participants will be asked to state if there is anything else left. Then, while thanking the participant, the possibility of needing an interview or the next question is raised. In addition to audio recording, the researcher will record all emotions, facial changes, tone of voice, etc. during the interview with a pen and paper. After the completion of the interview, the recorded items will be played carefully as soon as possible. The original interviews will be kept in confidential folders. Analysis and initial coding of the data of each interview will be done before the next interview. Of course, after conducting the interview, the text will be presented to the supervisors and the necessary guidance will be obtained to improve the next interview process.
Data Analysis
In order to answer the research questions and analyze the data, the qualitative content analysis method will be used. To analyze data in the first phase (qualitative study), the content analysis method will be used with a conventional (inductive) approach. The analysis process will be done simultaneously and continuously with the data collection and based on the approach proposed by Granheim and Lundman, through qualitative conventional content analysis (Graneheim & Lundman, 2004). After each interview, the researcher will type the information word by word and convert it into a text format. The entire text of each interview is considered as the unit of analysis, and then the meaning unit will be extracted from it. Since there is no previous underlying theory in line with the goals of the research, the categories will be created inductively from the raw data. After coding samples of the text, the coding process will be reviewed by the research team. The researcher continuously reviews the coding to make sure that there is an agreement between the extracted codes based on the researcher's inference with the opinion of the participants in the research and the research team. After the coding is completed, the stability of the coding will be checked again. With the help of the research team, the researcher will draw conclusions from the data and identify and revise the internal themes.
Accuracy of the Findings
Accuracy of the Data in the Development and Validation of Food Security Assessment Tool for Pregnant Women in Iran.
The Second Phase of the Research: Development and Validation of the Tool
First Step: Tool Development
This section presents the findings of the tool design process based on the concept of food security for pregnant women explained in the qualitative phase of the research. The steps of tool design include: explaining a conceptual model, explaining the measurement objectives, designing a road map, and making the tool using the mentioned steps along with setting the items and scoring rules.
Conceptual Model Preparation
Considering the subjective nature of the concept of food security for pregnant mothers, a conceptual model is extracted through the inductive method. In this way, the final operational definitions derived from the themes resulting from the contractual content analysis in the qualitative stage are the basis for the extraction of objects and the purpose of the tool.
Determining Research Objectives
The goals of the tool are determined based on the dimensions and areas of the qualitative concept of food security for pregnant women.
Road Map Design
Determining the specific areas of the measurable dimensions of the concept obtained from the qualitative stage requires determining and proposing the necessary items to measure each structure.
Developing the Tool (Extracting and Compiling Items)
In line with the second goal of the research, “designing a tool to measure the food security of pregnant women”, in this stage of the research, after conceptualization in an inductive way and after the final themes are abstracted, the concept of food security in pregnant women is defined, and its essence is understood. To be clear, based on this framework, the initial items of the questionnaire are extracted and abstracted from the initial codes. To simplify understanding and increase the validity of the items as much as possible, the participants’ own words will be used. The pool of formed items is reviewed again and the best items are selected. Among these, the items that are conceptually similar are removed or merged, and thus the questionnaire structures (dimensions or suitable factors and items) of food security of pregnant women will be designed and evaluated in the form of a methodological process, based on the perceived definitions.
Second Step: Validation of the Tool
This part of the research is of a methodological type, in which the validity and reliability of the food security assessment tool will be determined.
Validity
The methods of content validity, face validity, and construct validity (factor analysis) will be used to determine the validity of the food security assessment tool for pregnant women.
Face Validity
For qualitative face validity, 10 pregnant women participating in the research are asked to express their opinion about the level of difficulty, comprehensibility, and ambiguity of each item, and after summarizing and analyzing, the necessary changes will be applied. They are also asked to determine the importance of each item based on a Likert scale of 1–5. The impact score (I.S) of each item is calculated as the importance of each item multiplied by the number of times it is repeated. That is, the percentage of those who gave the item a score of 4 or 5 will be multiplied by the average score obtained for each item. Items with an impact factor of more than 1.5 will be considered appropriate for the next analysis, and items with a lower impact factor will be removed (Kyngäs et al., 2019).
Content Validity
The opinions of 10 experts participating in the research are used to determine content validity. Content validity will also be measured qualitatively and quantitatively. To evaluate the content validity of the tool, the opinions of experts in the field of food security, who are also skilled in the field of validation, will be used as an expert panel, and they will be asked about the following grammatical points, appropriate use of words, correct placement of phrases, grading, transparency, and the simplicity of the items, and after collecting the comments, the necessary corrections will be applied. In the quantitative section, the content validity ratio (CVR) and the content validity index (CVI) will be used for content validity (Polit & Yang, 2016). For CVR, 10 experts in the field of food security are asked to comment on the necessity of the questionnaire items based on a three-point scale (necessary, useful but not necessary, not necessary). Then the content validity ratio is calculated using the formula: The number of experts who have chosen the necessary option will be calculated minus half of the total number of evaluators divided by half of the total number of evaluators.
According to Lawshe, scores above .62 are considered appropriate (Lawshe, 1975). In order to calculate the CVI, experts are asked to evaluate the degree of relevance of each item with the desired structure with four statements” not relevant, relatively relevant, relevant, and completely relevant” and then the score of the content validity index for each item (R-CVI), which is the number of experts who gave each item a score of 3 or 4, will be calculated by dividing it by the total number of experts. Scores above .79 are considered appropriate, and scores between .7 and .8 are required (Rodrigues et al., 2017). The validity of each item (I-CVI) will also be determined using the modified kappa statistic (K*). The agreement score (adjusted kappa values) greater than .74 is desirable and will be maintained. The items with an agreement score between .6 and .74, which are considered appropriate, will be modified and retained, but the items with an agreement score between .4 and .59 will be removed (Zamanzadeh et al., 2015). In this research, the mean method will be used and items with S-CVI above .9 are considered acceptable.
Construct Validity
In this research, the differential validity of the tool will be investigated using the factor analysis method. This analysis is used to check the adequacy of the tool for measuring the investigated structure, which includes four basic steps: preparation of correlation matrix of all variables used in the analysis and estimation of sharing, factor extraction, selection, and rotation of factors to simplify and make the factorial structure more understandable for interpretation (Plichta et al., 2013). In this part of the research, exploratory factor analysis will be used to identify the relationships between the items and their relationship with the main variable under investigation, namely the food security of pregnant women and the constructs that make up the instrument. The Kaiser-Meyer-Olkin (KMO) test will be used to investigate sampling adequacy (Plichta et al., 2013; Polit & Yang, 2016). Bartlett's sphericity test will also be used to ensure that the correlation matrix, which is the basis of factor analysis, is equal to zero in the population (Ghazanfari et al., 2010). After calculating the correlation matrix between the variables, the factors will be extracted and the variables that have a high correlation will be placed in one category or factor. In this study, the sample size required to perform the exploratory factor analysis to check the validity of the construct is five times the number of items of the instrument (Speziale et al., 2011).
Research Population
The research population included all literate pregnant women referring to comprehensive health service centers of North Khorasan province.
Research Sample
In this research, the research sample will be selected from the research community based on the available sampling method and the characteristics of the research units. Inclusion criteria were as follows: Iranian women of reproductive age (15–49 years), being pregnant, willingness to participate in the study, being literate in reading and writing, being able to speak in Persian, having no underlying disease such as diabetes mellitus, blood pressure, heart, digestive system, liver, thyroid, immune system, blood, skeletal, muscular, nervous system, kidney disorders and hepatitis.
Data Collection Method
After obtaining the necessary permits from Tarbiat Modares University and North Khorasan University of Medical Sciences, data were collected with demographic questionnaires and a food security assessment tool for pregnant women by referring them to the comprehensive health service center in different cities of North Khorasan province. The researcher explained the voluntary nature of the mothers to participate in the research, the confidentiality of their identity and information, the stages of the study, and the right to withdraw from participating in the research.
Reliability
To check the reliability of the instrument, the method of internal consistency and stability determination will be used. Therefore, the samples of the construct validity determination stage (factor analysis) will be used to determine internal consistency (Cronbach’s alpha) and stability (retest reliability). If the women wish to continue participating in the study, their phone numbers will be collected and two to four weeks after the first date of completing the questionnaire, they will be contacted to complete the food security assessment tool of pregnant women again. Then, in the presence of the researcher, the participant will complete the tool again to determine the stability of the food security assessment tool for pregnant mothers.
Internal Consistency (Cronbach’s Alpha)
Cronbach’s alpha method is used for internal consistency, which indicates the suitability of a group of items that make up a construct. Since the minimum Cronbach's alpha coefficient accepted by the researchers is .7 (Suresh, 2018), it has been considered for this study.
Stability (Retest Reliability)
Investigating the stability of pregnant women’s food security assessment tool will be done using test-retest reliability. The important point in retest reliability is the time interval between the two tests. This time interval is stated as two weeks to one month (MacCallum, et al., 1999). Therefore, to determine the reliability, the instrument will be completed by a number of participants with an interval of two weeks, and the correlation level of the information obtained from the test-retest method will be examined with the Pearson correlation coefficient. The correlation between the results of the two tests estimates the value of reliability or reproducibility. If this index is above .74, it will be considered favorable.
Item Weights
After determining the factor loading of each item by exploratory factor analysis, the factor load of each item is multiplied by the ratio of the total variance explained for the factor on which the question is placed. Then, to determine the weight of each item in the entire subscale, the ratio of each of the secondary values to the total of the secondary values is calculated. After determining the weight of each item by factor analysis, the average weight of each item is calculated based on both methods, that is a fixed weight equal to 1 for all items, and weighting the items using factor analysis. In the first method, the work process is such that the weight of the items is assumed to equal to 1, then the average weight of the Likert values is calculated in each of the subscale items using the Friedman test (Suresh, 2018).
Convenience
This means that the tool is easy to use. The use of short, comprehensible sentences and a short time to answer questions of the tool are features that should be considered. Moreover, after collecting information, it will be determined by calculating the relative frequency of unanswered items for each item and describing the response of each item. The ease of use of the tool is done by examining the ceiling and floor effects. In this way, the percentage of grades at the end of the grading spectrum is used to check the ceiling and floor effects. If more than 15% of the respondents have obtained the highest and lowest possible score respectively, the ceiling and floor effect is considered (Suresh, 2018).
Scoring
Once the items are created and correlated with each other, the scoring rules should be specified. In most cases, the structure of the item determines how to score it. The selection of options that are appropriate to the nature of the items related to the dimensions of the questionnaire will be selected by consulting with the research team and experts based on a five-point Likert scale. The following formula will be used to unify scoring based on the 100 linear transformation standard (Suresh, 2018). Finally, a score between 0 and 100 is obtained, where a zero score means food insecurity, and the higher the score is, and the closer it is to 100, the more food security of the pregnant women in the study.
Data Analysis
SPSS software, version 22, will be used to analyze descriptive statistics as well as factor (exploratory) analysis, internal consistency, and test-retest reliability. In this research, exploratory factor analysis will be used to investigate the construct validity of the food security assessment tool for pregnant women. Exploratory factor analysis is used when little information is available about the factor construct and the aim is to discover the factor construct (MacCallum et al., 1999). Exploratory factor analysis makes it possible to determine the number of dimensions hidden by the tool, and with the help of exploratory factor analysis, it is possible to determine hidden variables and evaluate the weight of each and the relationship between the variables.
Discussion
Considering previous studies on the necessity of designing and developing special tools for pregnant women with respect to their specific nutritional conditions and their vulnerability compared to other groups of the population, as well as all the economical, social, and cultural factors affecting their food security (Iqbal & Ali, 2021; Rasty et al., 2015), we aimed to design and validate a tool to measure food security in Iranian pregnant women. In a systematic review in 2022, the researchers concluded that although there was a wide range of interventions to eliminate food insecurity and hunger among pregnant and postpartum women, the number of strong evaluations and long-term interventions was limited (McKay et al., 2022). In another systematic review, the authors reported that different questionnaires and scales have been used to measure the food security of pregnant women, and sometimes the instruments were adapted from the original versions, and also the lack of validation studies that confirm the adaptations made with the original instrument jeopardizes the reliability of the results reported by the authors making it difficult to compare and discuss the results of food security of pregnant women in different populations (Augusto et al., 2020). Others emphasized that one strategy for improving food security in pregnant women is the use of standard tools to screen food-insecure mothers during pregnancy so that after identification, referral and intervention, the outcome can be checked by the same tool (Canavan et al., 2022). For the first time in Australia, Zinga and colleagues conducted a qualitative study entitled “pregnant women’s food insecurity experiences and factors affecting their food choices”, indicating that understanding women's experience was a key step in developing effective strategies and interventions targeted at promoting the food security of pregnant women (Zinga et al., 2022).
The biggest debate in measuring food security is the general approach of the study, that is, the use of quantitative or qualitative research methods. While quantitative methods allow the researcher to have a broad picture of the frequency and severity of food insecurity, qualitative methods provide a deeper understanding of what food security or food insecurity means. Many researchers who value both approaches know and defend the use of both or a combination of methods. Therefore, it seems necessary to design a specific, reliable, and appropriate tool according to the social and cultural background of the country, based on the experiences of pregnant women, to measure food security in pregnant women, so as to adopt basic strategies and interventions to improve food security in pregnant women. The tool designed to measure the food security of pregnant women can be used during pregnancy care in comprehensive health service centers to identify food-insecure pregnant women so that necessary and timely interventions can be provided. In a systematic review, the household food security was studied in Iran, and the researchers concluded that the screening of the household food security status during the primary care of pregnancy can identify high-risk pregnant women, in order to improve the quantity and quality of their diet. Moreover, multi-level measures including policy-making, providing resources, and providing appropriate services are needed to ensure pregnant women's access to high-quality foods (Alimoradi, et al., 2015). The existence of a clear definition of the food security of pregnant women, as well as the design of a reliable and appropriate tool to measure it, can also be a starting point for conducting applied research in the field of food security of pregnant women. Therefore, the findings of this research can be used in designing and planning national macro-policies to improve the food security of pregnant women.
Footnotes
Acknowledgments
This paper is part of MB’s PhD thesis on reproductive health. The authors would like to thank Tarbiat Modares University for supporting this research.
Author Contributions
All authors were involved in the conception and design of the study. MB drafted the manuscript. All authors read the draft and provided input. All authors read and approved the final manuscript.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research is funded by Tarbiat Modares University, Tehran, Iran (Grant no. 52/1/7321).
Ethical Statement
Data Availability Statement
The developed guideline will be available from the corresponding author upon request.
