Study design
This study used a quasi-experimental study design with pre and post-test with control group involving two health clinics. Pregnant women in Salak Health Clinic were recruited as the control group and those at Dengkil Health Clinic were recruited as the intervention group. Both groups received routine antenatal care and practice which included iron supplementation from their respective clinics. Additionally, the intervention group was given theory-based health education intervention on anaemia in pregnancy. The study is conceptualized based on the Health Belief Model (HBM).
Study population
The sampling population is pregnant women in Salak and Dengkil Health Clinics diagnosed as having anaemia in pregnancy with haemoglobin (Hb) level of less than 11.0 g/dl and meet all the inclusion criteria. Subjects who met the following inclusion criteria were selected: Malaysian, pregnant woman with a Hb of less than 11 g/dl until 7.0g/dl that was booked before 24 weeks of pregnancy and want to continue her antenatal check-up at these clinics. Known case of anaemia secondary to haematological disorders, severe anaemia (Hb < 7g/dl) and women with multiple pregnancies were excluded from the study. The sampling method was all eligible women who attended the antenatal clinics during the recruitment process were invited to participate in the study.
Sample size estimation
The sample size was calculated using the formula for two population mean formula for hypothesis testing [27]. N = 2 S2 (z(1-α/2) +z(1-β))2/ (µ1-µ2)2 with S = pooled standard deviation, Z1-α/2 = 1.96 (confidence level of 95%, α is 0.05), Z1-β = 0.84 (power of 80%, β is 0.2), µ1-µ2 = estimated mean difference of two groups which µ1 and µ2 was selected from the study by Sennayake et al. [28]. Based on the above calculation, the minimum sample size needed consists of 81 pregnant women per group; after adjustment made for 20% attrition, eligibility of respondents and considering the design effect.
Outcome measures
The primary outcome of the study was haemoglobin level. The secondary outcome of the study was compliance level towards iron supplementation, dietary iron intake, knowledge on anaemia and HBM construct (perceived susceptibility, perceived severity, perceived benefit, and perceived barrier). The Hb level was measured before the 24 week of gestation (T0) and between week 35 and 37 of gestation in the third trimester (T1). The difference between T0 and T1 in the intervention group was compared with the difference in the control group.
Study questionnaire
The questionnaires consist of the following five sections. Section one was socio-demographic factors and maternal obstetrics information. This section extracts the socio-demographic characteristics of age, ethnicity, education level, employment status and socio-economic status. Maternal obstetrics history includes gravida, parity, period of gestation, and spacing between children
Section two looks at participants’ knowledge related to anaemia in pregnancy. The knowledge and perception questionnaire for this study was developed through adoption of structured questionnaire [29–30]. A total of 20 items were applied to assess the structured knowledge questionnaire. Each question has three options, “Yes”, “No”, and “I don’t know”. Correct answers achieve one (1) mark and incorrect answers or “I don’t know” achieve zero (0) marks. The total score for this section is 0 to 20, with higher values indicating better knowledge towards anaemia in pregnancy. The content validity as assessed by content validity index, result was 0.70. For reliability of knowledge section, Kuder-Richardson 20 was used, result was 0.81.
Section three tests the participants’ perceptions. The questionnaire was based on Health Belief Model including perceived susceptibility, perceived severity, perceived benefit and perceived barrier. Perceived susceptibility was assessed with 5 items, each rated on a 5-point Likert scale ranging from ‘strongly agree’ (5) to ‘strongly disagree’ (1). The total score for this section was 5–25 with higher values indicating better perceived susceptibility. Perceived severity consisted of 7 items, each rated on a 5-point Likert scale ranging from ‘strongly agree’ (5) to ‘strongly disagree’ (1). The total score for this section was 7–35 with higher values indicating better perceived severity. Perceived benefits were assessed with 5 items, each rated on a 5-point Likert scale ranging from ‘strongly agree’ (5) to ‘strongly disagree’ (1). The total score for this section was 5–25 with higher values indicating better perceived susceptibility. Perceived barrier consisted of 6 items, each rated on a 5-point Likert scale ranging from ‘strongly agree’ (5) to ‘strongly disagree’ (1). The total score for this section was 6–30 with higher values indicating poor perceived barrier. The content validity as assessed by content validity index, result was 0.75. For reliability of perception section, Cronbach alpha was 0.77.
Section four focussed on the level of compliance towards iron supplementation questionnaire. It consists of 4 questions that can measure participant level of compliance for iron supplementation [31]. Total score for this section was 0–4 with score of 0 indicating high compliance level, score of 1–2 indicating medium compliance level and score of 3–4 indicating low compliance level towards iron supplementation.
Section five looks at participants’ dietary iron intake. Three-day food record (2 weekdays and 1 weekend) was used to measure dietary intake [32]. Instructions were stated on the food record on how to measure servings without any leftovers of food. Pictures of household measurements such as spoon and cups were attached to the food records to facilitate serving size estimation. Also, other details such as method of cooking, ingredients used e.g. condiments and fat on meat were requested. Amount of food consumption including dietary iron by individuals were converted to milligrams by using dietary analysis software, Nutritionist Pro or Malaysian Food Composition Table. Data on dietary iron intakes were transferred from the Nutritionist Pro to the SPSS for statistical analysis. Dietary iron intake adequacy was assessed by comparison of energy and iron intake with the recommended nutrient intakes (RNI) for Malaysia pregnant women [10]. Dietary adequacy was considered achieved if the individual’s mean intake met or exceeded 100% of the RNI.
Intervention module
The intervention module was developed through the process of consultations with a group of experts, studying relevant literature and received opinions from the community being served. The goal of this health educational intervention is for behavioural change. The module development was guided by the Health Belief Model (HBM). The HBM addresses four major components for compliance with recommended health action: perceived barrier of recommended health action, perceived benefits of recommended health action, perceived susceptibility of the disease and perceived severity of the disease.
Intervention strategies
This program was implemented using three strategies: Pre and post intervention assessment and health education intervention. The pre-test assessment was measured through study questionnaire given to the participating women before 24 weeks of gestation and followed by the health education intervention was held within 12 weeks (3 month). There is a variety of learning activities during that period that include health talks, small group discussions, poster presentation and pamphlets. Post intervention evaluation was measured between the 35th to 37th weeks of gestation in the third trimester.
Baseline assessment
Prior to starting the intervention programme, baseline or pre-test assessment need to be performed among the anaemic pregnant women at the selected health clinics prior to health education program to identify their baseline haemoglobin level, socio-demographic status, baseline status of their knowledge, perception towards anaemia in pregnancy, dietary iron status and compliance level. A set of self-administrated study questionnaire was used to capture the baseline data. All participants must give their consent prior to answering the questionnaires and their answers are made confidential.
Post intervention assessment
After the completion of the twelve-week intervention period, the impact and outcome evaluation of the intervention programme was carried out using a set of questionnaires. The same set of questionnaires that was used in the pre-intervention assessment, except their socio-demographic status, was distributed to the participants. The post intervention haemoglobin level was taken from the participants’ antenatal book. The outcome of the activity was to determine a post-intervention level of knowledge, perception and anaemia preventive behaviour after health education program.
Health education intervention
Health education interventions were implemented after a pre-intervention assessment has been conducted. The health education intervention periods was held within 12 weeks. There is a variety of learning activities during that period. The methods and material of the theory-based health intervention programme included health talk, small group discussion, poster presentation and pamphlets.
The health talk was given by the researcher on the topics such as introduction to anaemia in pregnancy, predisposing factor, sign and symptoms, complication, prevention of anaemia in pregnancy, knowledge on wrong perception of anaemia and iron supplementation and knowledge on the various sources of food that contain high iron. It is subsequently followed by a question and answer session or activity. In this activity, participants are able to ask anything regarding anaemia in pregnancy. The health talk was given once for each participant during the intervention period in form of power point presentation for about one hour. The outcome of the health talk would enable participants to gain knowledge on the facts of anaemia in pregnancy, complication of untreated anaemia and management of anaemia in pregnancy (iron supplementation and dietary iron intake) and its importance.
The second activity of the health education intervention programme was small group discussion. A session on small group discussion was conducted and facilitated by the researcher between two to four weeks after the health talk. The participants were divided into nine small groups with eight to ten participants in one group. Each group was encountered one session during the intervention period based on timing of the participants. This activity deals with the issues to enhance the compliance towards iron supplementation and to increase the dietary iron intake by identifying their barriers towards anaemia preventive behaviours. The outcome of the discussion would enable participants to understand the severity of anaemia in pregnancy, understand the susceptibility of anaemia in pregnancy, identify and overcome the barrier of not comply with iron supplement and dietary iron intake and identify the benefit of taking iron supplement and dietary iron intake. The participant also was provided with the checklist on compliance for iron supplementation. The time required to complete the group discussion session is within 60 minutes.
The materials used in the health education intervention programme are posters and pamphlets. The posters and pamphlets were designed to make teaching interesting and receptive. Two posters were used in this activity. A large poster (A1 size) was placed in the health clinic at all time during the intervention period. There was information regarding the complication of anaemia and importance of taking iron supplementation and consumption of iron rich food. In addition, the participants were given a small poster (A4 size) to bring home as their continuous learning material after the small group discussion session. The small poster was to provide guidelines of various iron rich food. A checklist on compliance towards iron supplementation was pasted in the maternal health record. Apart from that, a pamphlet also was distributed to the participants as a self-learning tool and continuous material that aimed at enriching their information about anaemia after the health talk or small group discussion. It also helped to deliver take home messages to the participants about anaemia in pregnancy. It was covered the information regarding the definition, causes, complications and prevention of anaemia in pregnancy and examples of food rich of iron. These materials were also aimed to maintain adherence towards anaemia preventive behaviour.
Statistical analysis
Data was analysed using IBM Statistical Package for Social Science (SPSS) version 25.0. Per protocol analysis was adopted as primary analysis in this study. Per protocol analysis were utilized for those completed all 2 data collection point and included in the final analysis.
Descriptive statistics using continuous data was analysed using means, standard deviation, median and inter-quartile range. While categorical data analysed using frequencies, percentage. Normality of the data was checked using histogram, Kolmogrov-Smirnov and Shapiro-Wilk normality test. An outcome variable was compared at the baseline and post-test. For within group difference, if data were assumed normal distributed data, parametric test such as Paired t test was utilized. But if data were assumed non-normal distributed data, non-parametric tests such Wilcoxon Signed Ranks test was utilized. Apart from that, Mc Nemar Test was used to determine the association of two categorical related variables. For between groups difference, if data were assumed normal distributed data, parametric test such as Independent t test was utilized. But if data were assumed non-normal distributed data, non-parametric tests such Mann-Whitney U test were utilized. Chi Square test and Fisher Exact were used to test the association between two categorical variables. Multivariable analysis was done using generalised estimating equations (GEE) to determine the effect of intervention on the primary and secondary outcome after adjusting for the covariates. The effect of intervention on changes in outcome measures was determined three months after the intervention period.