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Explaining the experience of breastfeeding in women with gestational diabetes and designing and implementing an educational program based on planned behavior theory: a combined exploratory study protocol | Reproductive Health

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A mixed methods exploratory design will be used to conduct this study in 3 phases. The first phase (qualitative): The purpose of the first phase is to understand women’s experience of gestational diabetes, which will be done using the directed content analysis method. Breastfeeding in mothers with gestational diabetes is a multidimensional concept that is rooted in the subject of mothers and forms in the context of a society with the cultural complexities of that society. Breastfeeding behavior is the result of a mother’s interaction with herself and her world. In addition to attitudes, this behavior is influenced by important others and the control of a mother’s perceived behavior, therefore, for a deep understanding of this phenomenon and to explain the concept of understanding and breastfeeding experiences of women with gestational diabetes, a directed qualitative approach based on the theory of planned behavior will be used.

The second phase: Designing and implementing an educational program based on the theory of planned behavior: From the findings of the qualitative phase, the educational needs of participating mothers with gestational diabetes will be extracted. At this phase, observation, in-depth interviews, and interviews with key and knowledgeable participants will be used as techniques for assessing the needs.

Sample size and sampling method

Following the approval of the research project by the Ethics Committee of Mashhad University of Medical Sciences, the purposive sampling (pregnant mothers with gestational diabetes 30–34 weeks and mothers with infants (up to 6 months) with a history of gestational diabetes in the last pregnancy) with maximum diversity in terms of mother’s age, mother’s education, infant’s age, and breastfeeding experience, after stating the objectives of the research and obtaining informed consent, women will enter the research and the necessary coordination will be made regarding the appropriate time and place for the interview. Women who are willing and able to explain their understanding and experience of menopause symptoms and its effect on life will be selected and the interviews of this stage will begin. In the in-depth interview approach, the interview begins with an open question and is followed by targeted questions related to the predicted classes of the theory of planned behavior. The qualitative phase of the current study includes the needs assessment of mothers with a history of gestational diabetes, which is the first step in designing an educational program, along with a literature review. At this stage, the researcher went to hospitals, comprehensive health centers, and health care centers and conducted semi-structured, in-depth interviews with mothers who have the conditions to describe their experiences and perceptions. To gain their trust, they will ask to express their needs, opinions, and beliefs in the field of breastfeeding in simple language. In this way, their experiences, behavioral beliefs, subjective beliefs, and control beliefs in the field of breastfeeding behavior will explain to complete the matrix of various structures of the theory of planned behavior (attitude, subjective norms, perceived behavioral control, intention, and behavior). In qualitative research, it is not possible to determine the sample size in advance and it is determined during the study. Interviews will continue until reaching data saturation or when no new data is available to complete and enrich the classes developed during the research.

Inclusion criteria

In the qualitative part of the study, the mothers with infants under one year of age with a history of gestational diabetes in the last pregnancy under the coverage of comprehensive health centers who do not have any other medical diseases and are willing to participate in the study will participate by obtaining written consent.

Data analysis

Qualitative content analysis, which is used to mentally interpret the content of written data, identifies codes and themes through a systematic classification process [22]. In this research, there is a pre-determined format and matrix based on the structures of the theory of planned behavior (attitude, subjective norms, perceived behavioral control, intention, and behavior), and content analysis with an inductive approach based on the structures of this theory will be done. Therefore, directed content analysis will be used to perform the analysis. Data analysis in mixed-method research is considered to be a part of a cyclical four-step process (information collection, data analysis, data interpretation, and validation) whose steps affect each other [23]. Obviously, in this study, data collected through interviews, group discussions, and continuous comparison methods is used for data analysis. With the arrival of new data, the process of data comparison and classification will continue with new codes extracted and integrated into the previous data. With the progress of research, interviews, and observations become more focused. The circular approach and continuous backward and forward along with constant comparison and data collection and classification will explain the main concepts, theoretical relations, and processes and finally identify the main variable and the base on the theory. Therefore, in the current research, data collection and interpretation will be done in parallel. We will use four criteria to evaluate the accuracy of the qualitative data (Credibility, Dependability, Confirmability, Transferability [24]. The interview texts and codes will organize in MAXQDA.

Data connection and integration

In this mixed study, the researcher will use data connection and integration. It means that the findings of the qualitative parts of the study will be used in the direction of revision (compilation of the educational program for mothers with gestational diabetes) based on the theory of planned behavior. Therefore, in addition to the fact that the data of each of the qualitative and quantitative stages will be analyzed separately, by summarizing the results of the qualitative and quantitative stages, the educational needs of mothers will be identified and prioritized, and an educational program based on the theory of planned behavior will be designed and implemented [25].

The second step, designing the educational program

The educational program based on the constructs of the theory of planned behavior will include designing program goals, implementation, and evaluation. The design of educational intervention can be divided into two basic steps:

  1. A.

    Determining goals (by experienced experts)

After the needs of mothers with gestational diabetes were extracted and listed through qualitative data, and literature review, the needs of mothers with gestational diabetes will be prioritized as follows. First, to prioritize the needs of mothers with gestational diabetes, criteria will be considered that include the prevalence of the problem, the severity of the problem, the ability to intervene (can the problem be solved with the available resources?), the government’s concern (do planners and policymakers want to solve the problem?) and society (do the individuals involved in this issue want to deal with the problem?). The mentioned criteria will provide the possibility of selecting priority problems in a ranked table (Likert 1 to 5). For prioritization, the opinions of 6 to 8 experts composed of neonatologists, gynecologists, and health education specialists in various fields of reproductive health, breastfeeding, and midwifery education and one diabetic mother and experienced experts will be participated, then needs that can be planned and implemented will be prioritized and selected. In this regard, a focused group will be discussed with interested and experienced experts in various health fields. The focus group approach is a very efficient and useful method for extracting different ideas and opinions and pondering them. This approach is a type of group discussion, the main purpose of which is to identify different points of view on the topic under discussion and to understand the issues from the perspective of different individuals [26]. In this study, the research team, using the results of a qualitative study and a literature review and searching in reliable scientific databases and line with the existing instructions and guidelines, will pay the general and specific goals of the educational program based on the priority needs of mothers with gestational diabetes.

  1. B.

    Elaboration of educational intervention

The results obtained in the previous phases will reveal which structures (attitude, subjective norms, perceived behavioral control, intention, and behavior) have the highest priority as the focus of intervention planning. In addition to the results of the qualitative part of the study, the results of the pre-test will show which structures have the highest and lowest scores, which structures have the most problems, and which structures are more important for learning. Based on the results obtained from the qualitative stage and the results of the pre-test, the researcher will explore, and review interventions and programs of changes regard to breastfeeding behavior in Iran and other countries and search in reliable scientific databases. After that, to determine the educational content and plan educational sessions in the field of breastfeeding behavior of these mothers, a meeting will be held consisting of the research team and a group of health, gynecology, and pediatric experts from the health department of Mashhad and Ardabil University of Medical Sciences. By using the existing instructions and guidelines and the opinions of the research team and experts, the appropriate educational methods are selected to achieve the set goals according to the structures of the theory of planned behavior. To achieve each goal, the best and most applicable educational method must be determined. Based on this, at the end of this stage, the design and implementation of the plan will be determined. Then, the (educational) content will be provided to a group of mothers with gestational diabetes to ensure its comprehensibility.

Quantitative phase methodology

Quantitative studies are regular and systematic studies in which data are collected objectively and phenomena are studied with precise and quantitative measurements. In these studies, the obtained data are tested or described with statistical techniques [23]. Interventional studies are a type of quantitative method used to test scientific hypotheses. In experimental methods (randomized controlled clinical trials and semi-experimental designs) an intervention program is used to achieve the goals of the test, which is measured through a set of predetermined indicators. In semi-experimental designs, there is a comparison group that has the same basic characteristics as the intervention group, and after the implementation of the intervention program in the intervention group, any difference between the results of the control and intervention groups is measured [27]. Semi-experimental designs facilitate the investigation of causality in situations where complete control is not possible. Pre-test-post-test design with a comparison control group is the most common design used in research [28]. In the current mixed study, the quantitative phase will aim to determine the impact of education based on the theory of planned behavior on the breastfeeding behavior of women with gestational diabetes, which includes implementation and evaluation.

Research population

Mothers with a history of gestational diabetes and infants up to one year are covered by comprehensive health centers, and also who are eligible for the research sample.

Inclusion criteria

Pregnant mothers over 36 weeks or with infants in the first 6 months with a history of gestational diabetes in the last pregnancy; not having a chronic or acute disease other than gestational diabetes; willing to participate in the research and answer the questions of the questionnaire with written consent; singleton pregnancy; not having a disease whose treatment interferes with breastfeeding.

Exclusion criteria

Having breast diseases that prohibit breastfeeding; suffering from diseases whose treatment interferes with breastfeeding; mothers use of antidepressants and psychotropic drugs; mothers giving birth before the end of the fourth session of intervention; hospitalization of the baby; hospitalization of the mother; intrauterine death of the fetus.

Sample size and sampling method

Sampling of the quantitative part of the study will be done randomly. Four health centers will be randomly selected. Two centers for the intervention group and two centers for the control group. The participants will be eligible mothers referred to the selected health centers and comprehensive health centers. After providing explanations about the study, written informed consent will be obtained. A randomized controlled method will be used regarding the purpose of the study and using the Apple system that exists in comprehensive health centers. The intervention and control groups are made up of mothers with a history of gestational diabetes covered by the mentioned centers. For blinding of the intervention, the control group will be selected from other healthcare centers and they will not receive any intervention from the research team during the study.

Sample size

Since no similar article was found on breastfeeding in mothers with gestational diabetes, first a pilot study will be conducted to determine the sample size.

Data analysis

After collecting quantitative data, the data will be analyzed by SPSS software 21. The normality of data distribution of quantitative variables will be evaluated using the Kolmogorov–Smirnov test. Independent t-test/Mann–Whitney will be used to compare normal/abnormal quantitative variables in two groups (inter-group) and paired t-test/Wilcoxon will be used to compare normal/abnormal quantitative variables (intra-group). A significance level of 0.05 will be considered.

Quantitative program evaluation In a quantitative study, the impact of the educational program for mothers with gestational diabetes will be evaluated using the “breastfeeding Drop” survey tool, which is planned based on the planned theoretical constructs. With this tool, changes in “attitude, subjective norms, perceived behavior control, intention, and behavior” will be measured and compared in two intervention and control groups.

Tool description The “Breastfeeding Drop” survey tool, is a valid and reliable 52-question Likert-scale tool based on the theory of planned behavior and has the domains of “attitude, subjective norm and perceived behavioral control about breastfeeding”, and was designed by Janaki in 1994. This tool is also known as the “Breastfeeding Behavior Assessment Tool”. Out of 52 items of this tool, 29 are attitudinal items, 13 items are related to subjective norms and 10 items are related to perceived behavioral control. Participants will answer each item of this questionnaire on a six-point rating scale. Based on the theory of planned behavior, attitude items as beliefs related to the consequences of a certain behavior are multiplied by the score resulting from its positive or negative evaluation [29]. The validity and reliability of this tool were done in Iran in 2015 [30].

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