2.1 Study Design
The study was an interventional evaluation study with before and after comparison conducted over three years duration starting from Jan. 2017 till Jan. 2020. A quasi-experimental design with random selection and posttest-only control design was done. Two villages were included in the study as intervention and control villages. Two methodological approaches were used; the first was through comparing the conducted practices as a result of the intervention between the intervention villages with those who did not receive any intervention in the non-intervention village. The second was through looking for the direct evidence: Assessing the change of the breastfeeding practices as well as the growth before and after the interventions within the intervention village which mean that the study group served as self-control.
2.2 Study setting and participants:
The intervention village: El Othmanyia village of El Mahala El Kobra district– Gharbyia governorate was selected as the site of the project implementation. El Othmanyia village total women in the childbearing period (19–45 years) were 2100. The control village was chosen as a matched group from a nearby adjacent control village (Nemra el Basal village) with similar socioeconomic status.
The selected villages have powerful and active well organized community-based associations with on-ground community health workers (CHWs) who were trained and serve as key players for the provision of the motivational messages to the target groups.
2.3 Target groups:
2.3.1 Primary group (direct and indirect beneficiaries)
The direct beneficiaries included pregnant women in their third trimester to help them have the best start and initiate their breastfeeding as soon as possible after birth, also mothers of newly born (0–6 months) and mothers of infants aged 6 months to 2 years old. A total of 600 mothers of infants aged less than 2 years and 46 pregnant women were engaged in the interventional study as a direct beneficiaries.
Women in their childbearing period were also targeted as indirect beneficiaries (n = 1454). A total number of 2100 women, including women who intended to breastfeed their infants and those who did not and who signed informed consent forms, were targeted. The age range of the women enrolled in the study was 19–45 years.
2.3.2 The secondary target group
People who influence mothers to breastfeed and those having a strong influence over women’s decisions about feeding their infants. This group included the CHWs, who are healthcare providers (nurses and physicians).
2.4 Phases of the study:
The study was conducted in phases; the first was the formative assessment research followed by the interventions phase and ended by evaluation for measuring the outcome and impact.
2.4.1 Basis for sample size calculation during the assessment and evaluation phases (20, 21):
A sample size of 141 houses produced a two-sided 90% confidence interval with a width equal to 0.100 when the sample proportion for exclusive breastfeeding up to 6 months of age is 0.130 (12) which was rounded to 150 households. Houses were randomly selected out of houses of the direct beneficiaries; those who have pregnant women in their last trimester and/or mothers of infants 0–2 years were enrolled in the study. A total number of 200 women who were resident in these houses and who fulfilled the selection criteria were included in the assessment and evaluation stages through a longitudinal study together with their infants up to 2 years.
2.4.2 Phase one; assessment phase:
Participant in-depth interviews and formative research were used to collect data from the beneficiaries. The in-depth interview focused on listening from the attending mothers about problems they met in their previous breastfeeding experience and offering the best solution for each. Community consultation to help identify the “Best practices”, those appropriate, convenient, and suitable with local culture, capabilities, and the physical environment was also conducted. Meanwhile, the formative research was used to assess the current situation of breastfeeding practices and identify the behaviors to be targeted, pricing, and the promotional messages. The formative research also identified the factors that influenced mothers’ decisions to breastfeed and those that hinder or encouraging women to breastfeed as well as the spokespersons for promoting breastfeeding. All practices were determined according to the designed pre-tested questionnaire.
2.4.3 Phase two; intervention phase:
The interventions included capacity building of the activities’ implementers (the secondary target group) by the research team specialists from the National Research Center of Egypt which lasts for 4 months. The training was directed to 7 CHWs; 5 nurses and 2 physicians of the rural health unit of the intervention village. So that they became community educators delivering the right messages about proper breastfeeding practices to caregivers. They were targeted by the educational toolkit developed by the related researchers which tailored more specifically to their needs and respected their norms according to the finding of the assessment phase.
Health education and counseling interventions targeted 646 of the direct beneficiaries and 1454 women in their childbearing period (indirect beneficiaries) with a total no of 2100 women. The longitudinal interventions followed over 646 mothers from early pregnancy throughout their infant’s second year of life.
Counseling sessions related to the importance, early initiation, continuation of mothers to successfully breastfeed their infants and identifying the warning signs that need breastfeeding consultant intervention were delivered along 12 months to target the primary beneficiaries. For Each mother 10 messages were delivered along 3 months; 3 messages were covered in the first session during the first month and 4 messages were added and covered in the second session during the second month and 3 different messages were added during the third session during the third month. Then, this is followed by repeating the same messages every 3 months. Accordingly, along 12 months implementation 4 rounds were conducted to cover delivering the messages to all targeted participants. The first set of messages were attended by 646 pregnant women and lactating mothers for children less than 2 years in addition to 1454 women in the childbearing period. The second set of messages was attended by 406 mothers, 1392 women respectively, and the third by 313 mothers and 1306 women respectively. The activation process for the targeted primary and secondary groups with follow up was conducted along 28 months.
Flow diagram of the educational interventions implementation process, messages, reach, engagement, tools, giveaways and demonstrations used to disseminate motives to cause change, was illustrated in Fig. 1
The interventions were based on the use of social marketing approach. This approach was based on using the motives for successful breastfeeding practices and overcoming the detected obstacles and factors contributing to declining of breastfeeding practices for improving breastfeeding practices along one years of interventions for educating the targeted primary group.
2.4.3 Phase three; evaluation phase:
The end-of-study evaluation was done once the interventions had been completed through using a participatory approach by CHWs under the supervision of the study team. To measure the intervention effectiveness, mothers and their infants were assessed and evaluated by the same structured questionnaires to test the breastfeeding practices and infants' growth before and after the interventions. Moreover, to measure if mothers liked the activation process or not both the reach (first-time attendance) and the engagement (more times of attendance). Measuring the reach and engagement was done for the direct primary group (the direct beneficiaries)
The key performance indicators (KPIs) to monitor the success of the interventions were:
1. Early initiation of breastfeeding
2. Exclusive breastfeeding (EBF) under 6 months
3. Continued breastfeeding at 1 year
4. Continued breastfeeding at 2 years
5. Children ever breastfed
6. Predominant breastfeeding under 6 months
7. Bottle feeding
8. % Responsiveness to cues of hunger and satiety
The agreed definitions of the relevant Breastfeeding: the child has received breast milk (direct from the breast or expressed). Exclusive breastfeeding: The infant has received only breast milk from his/her mother or a wet nurse, or expressed breast milk, and no other liquids or solids with the exception of drops or syrups consisting of vitamins, mineral supplements, or medicines (22) Predominant breastfeeding “allows” Oral Rehydration Salts (ORS), vitamin and/or mineral supplements, ritual fluids, water and water-based drinks, and fruit juice. Other liquids, including non-human milk and food-based fluids, are not allowed, and no semi-solid or solid foods are allowed.
2.5 Social marketing (SM) approach:
Health education through using social marketing principles (18): The implementation of the market plan focused on increasing the reach and engagement of mothers to have a profound impact and sustained success of breastfeeding. The marketing plan included the following:
2.5.1 Target Behaviors (outcome)
1. Increase breastfeeding early initiation rates
2. Increase breastfeeding duration rates till 2 years
3. Increase rate of EBF under 6 months
4. Increase general public support for breastfeeding practices
The Product is breastfeeding. The choice of breastfeeding benefits that has been emphasized was identified during formative research according to each targeted behavior.
The formative research indicated that the emotional benefits to the baby were emphasized more than the health benefits be more influential with mothers.
For addressing the price factor, the marketing plan focused on interventions to lower the identified costs (barriers to breastfeeding and Faulty beliefs) or make them more acceptable.
Encouragement of responsive feeding of mothers’ to their babies’ cues of hunger and satiety is free of charge. The following guiding principles during breastfeeding were provided and all are free of charge; feed directly or assisted, feed slowly and patiently, encourage feeding without forcing, avoid distractions while talking and looking at the child.
Moreover, behavioral change through the SM approach was applied to overcome the identified barriers through teaching the health providers to increase the awareness and concern of the mothers of breastfeeding's motives (benefits) and help mothers develop ways to lower the costs (barriers) most relevant to them personally.
The Place factor was addressed through using the governmental public health facilities (the village rural health unit) and the village community-based associations to make these public settings more welcoming to breastfeeding women. Moreover, nursing women were also reached at their homes through the CHWs.
Interventions to facilitate support for breastfeeding practices through professional training directed towards nurses, physicians, and health workers at the rural health unit as well as the village community-based association’s members so that they could discuss breastfeeding with family members and friends
2.5.5 Promotion and Motives:
The promotional messages targeted factors detected to motivate and deter from encouraging women to breastfeed. The promotion messages used were out of the reported motives by ever breastfed mothers (190 mothers) that were expressed by more than half of the mothers; mainly: Save money, time, and effort, increase the mother-baby bond, and boost the child's immunity. In addition reasons for not using the pacifier were also added to the motives.
The slogan of promotion to breastfeeding “nurse me like a baby” was used for message distribution. Catchy, innovative messages were developed on the basis of the detected motives and that was in line with the village local context and according to their cultural and behavioral insights. The messages were converted to posters and cards.
The messages were from babies to their mothers “one thing I wanted to tell you, my mom, once I'm out nursing me like a baby. Breastfeed me for the 1st 6 months, and don't give anything else before I'm 6 months, continue breastfeeding me for up to two years. The only food I will love is the one coming from you. When you breastfed me you will not only save money, time and effort but also increase my immunity and I feel you and you feel me in your heart, please do not use the pacifier as it makes me vulnerable to infection. LOVE you, mom."
2.5.7 Change support process:
Some tactic points were used to support the SM approach through:
• The village’s pediatricians were requested to encourage breastfeeding over other substitutes while providing recommendations for the mothers as they are reported by mothers to be out of the influencers.
• Nurses were trained to help mothers on how to start and overcome the initial challenges of breastfeeding.
• distributing maternity messages for moms having android mobiles using WhatsApp application to provide them with tips on breastfeeding
• Mothers were introduced to the competition, those who answer all questions regarding breastfeeding wins a grand prize (breastfeeding pumper) and those who joined the competition received free breastfeeding covers
• To encourage mothers to breastfeed in public and increase breastfeeding times over non-breastfeeding times in outdoor areas, the breastfed women were provided by the breastfeeding cover (gown) to encourage mothers to breastfeed anywhere
• Mothers who shared their breastfeeding experience received breastfeeding covers as an incentive.
A well-structured questionnaire was applied to the target groups through an interview to collect the nutritional data. The Centers for Disease Control (CDC) Infant Feeding Practices Questionnaire (23) was used to measure feeding practices throughout the first year of life. Food fed to the infant, including breast milk and infant formula, patterns of breastfeeding, solid food intake, and other complementary foods and liquids were recorded. Moreover, factors that may contribute to infant feeding practices and to breastfeeding success and other issues (food allergies, experiences with breast pumps and pacifiers) were also investigated. As part of the study, each mother received a number of self-report questionnaires at baseline, then monthly during a 1-year follow-up after attending her three sessions.
Growth assessment was done for each infant aged less than 2 years twice (prior and after the interventions) using anthropometric parameters as follow:
The researchers, who are biological anthropologists, took anthropometric measurements on the infants, including weight, supine length, occipito-frontal circumference (head circumference HC), and mid-upper arm circumference (MUAC) on the left hand. A flexible, non-stretchable measuring tape was applied to assess measurements to the nearest 0.1cm, following standardized research protocols and Quality control measures elaborated for the World Health Organization Multicenter Growth Reference Report (24).
Each infant was examined by the Holtain Body Composition Analyzer. The presence of any metallic element with or beside the participant should be avoided. The following parameters were derived : the percentage body fat (Fat %: an estimate of the proportion of fat to the total body weight.), fat mass (FM: an estimate of the fraction of the total body weight that is adipose tissue), fat free mass (FFM: an estimate of the fraction of the total body weight that is not adipose tissue), Basal metabolic rate (BMR: to the setting of daily energy requirements and scientific diet guidance) (25, 26) and Total Body Water (TBW: an estimate of the fluid occupies intracellular and extracellular spaces, comprising about 0.6 L/kg (63.3%) of body mass) for hydration assessment (27, 28).
After data cleaning, all completed questionnaires were entered into the computer. Statistical analysis was done by using the Statistical Package of Social Software program (SPSS), version 20. The data were summarized using descriptive statistics where mean and standard deviation were used for quantitative variables. Number and percentage were used for qualitative values. Before and after the intervention, related indices were compared between the intervention and the control village with Pearson’s Chi-square test (χ2) and Z test (for qualitative data) and with paired t-test (for continuous data between the pre and post interventions of growth parameters). A P-Value less than or equal to 0.05 was considered statistically significant