Background
Undernutrition is related to around 45% of all the deaths in children annually or 2.7 million children dying globally. To encourage the growth, development and survival of infants and children the recommended breastfeeding practices of early initiation within 1 hour, exclusiveness till 6 months, safe complementary solid foods at 6 months with continuation of breast feeding till 2 years and beyond.1 Breastmilk is the ideal food for infants, offering unmatched safety, purity and antibodies that defend against a variety of childhood diseases. Even in the second year of life, it contributes to about one-third of the child’s needs.2 Each year optimal breast feeding saves 820 000 lives of children less than 5 years of age.3 Breast feeding for longer duration is also linked to decreased incidence of diabetes mellitus, hyperlipidaemia, obesity, hypertension, myocardial infection, breast and ovarian cancers in mothers.4–7
Barriers to Exclusive Breast Feeding (EBF) included low awareness of benefits of breast feeding, cultural practices of prelacteal feeds, myths of insufficient breast milk, colostrum, bitterness of milk and weakness of the mother. Among other barriers are undernutrition of mothers, less birth spacing, mother’s occupation, not proper latching or positioning, maternal and child ailments, abnormalities in breasts, and influence of family to start top up feeds.8–11 Educating mothers on breast feeding makes them more knowledgeable, concerned and prepared with a tendency to improve breast feeding.12–14 Mother and infant skin-to-skin contact soon after birth are reported by a study of having beneficial effects on breast feeding.15 Smartphone-based applications have a convincing positive influence on mothers breastfeeding knowledge, self-efficacy and practices.16 Increased utilisation of antenatal care (ANC), health facility services, skilled attendance at birth by pregnant women were also observed with _targeted m-Health interventions.17 The breastfeeding care plus programme improved perception of breastfeeding self-efficacy in the first 4 months post partum compared with routine care, which favoured competence of mothers and families with breastfeeding exclusiveness and duration.18 A regular individualised support has also resulted in behavioural change and improved exclusive breastfeeding rates.14 A multidimensional approach involving mother, her family, healthcare providers working in health facilities and community outreach programmes prelacteal feedings can be reduced by 25% and EBF can be improved by 23%.11
As reported in Pakistan Demographic and Health Survey, infant mortality rate is 62 deaths per thousand live births. 86% of pregnant women in Pakistan receive ANC. In 2018, over 28 years, there has been an increase from 13% to 66% in facility-based deliveries. Similarly, 69% of births are attended by a skilled provider. At the age of 0–1 month, 2–3 months and 4–5 months, the infants exclusively breastfed are 56%, 52% and 35%, respectively, with a rapid decline after 3 months.19 20 With lady health workers (LHWs) within the community acting as a backbone of primary care delivery at village level in place with a mandate to improve child mortality and nutrition but with limited focus on breast feeding21 gives an opportunity to strengthen and use the existing resources in low-income to middle-income countries and develop a coordinated continuum of care programme from pregnancy to 6 months postpartum to improve ideal breastfeeding practices.
When relevant interventions are delivered adequately, practices and responsiveness to breast feeding can improve rapidly. When interventions are concurrently implemented via several channels only then better outcomes are achievable.22–24
Rationale of the study
There has been constant improvement in utilisation of maternity services in healthcare facilities from skilled health providers. There is also an improvement in communication and excess to information with the use of cell phone technology in almost every household via telephone call, text messages and WhatsApp application. In parallel population of Pakistan, a developing country is on a steep rise which brings along poverty and food insecurities. In order to secure health and well-being of both mother and newborn in developing countries, it is inevitable to educate, encourage, support and convince mother to follow ideal breastfeeding practices to improve survival and health of children with practices which comes at a minimal cost but huge benefits. Keeping in view the best practices and all the available opportunities, a continuum of care programme for breast feeding from health facilities with extension to the community where mothers reside, using available resources in a systematic and continuous manner to educate, support and motivate mother and her family is inevitable.
This study will assess the feasibility and acceptability of continuum of care programme in parallel to the already existing support system till 6 months post partum which is both health facility and community based to encourage early initiation, exclusive breast feeding till 6 months and conviction of continuation of breast feeding till 2 years and beyond. The study will inform a definitive randomised controlled trial (RCT).
Study design
Two-armed, parallel groups, pilot RCT with random allocation of as 1:1 ratio in the intervention and control group (figure 1). Study schedule is according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement 2013.
SPIRIT schedule of enrolment, interventions and assessments. SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials.
Study setting
Outdoor patient department (OPD) of gynaecology and obstetrics department of government, Aziz Bhatti Shaheed Teaching Hospital (ABSTH) Gujrat, Punjab Pakistan.
Study participants
Pregnant women attending prenatal clinic, meeting inclusion and exclusion criteria will be invited verbally to participate in the study. Enrolment will only be done with their informed consent.
Inclusion criteria
Age over 18 years, 28–32 weeks gestation, nulliparous or multiparous, communicates verbally in Urdu or Punjabi languages, intends to deliver at ABSTH, Gujrat and has excess to smart phone with WhatsApp application.
Exclusion criteria
LHW not appointed in mother’s community, not able to articulate, medical conditions or illness hindering in understanding or breast feeding.
Sample size
There is no definitive rule or formula for calculating the optimal sample size for a pilot test, but some general principles should be taken into consideration. A sample size of minimum 12 participants in one arm for a pilot study is considered as a rule of thumb. A sample size range of 24–60 participants is derived from general guidance found in the literature on pilot and feasibility studies and a practical guideline for ensuring enough participants to assess feasibility and preliminary outcomes without the expectation of statistical power for efficacy or effectiveness analyses.25–27 Keeping in consideration 20% attrition rate of the pilot sample,28 50 participants in total will be considered for the study.
Recruitment
Recruitment will be done on 3 days a week of routine OPD of gynaecology and obstetrics department teaching unit of ABSTH based on inclusion and exclusion criteria. Informed consent in Urdu or Punjabi language from all participants agreed to participate in the study up till 6 months postpartum will be taken.
Randomisation, allocation and blinding
Simple randomisation, the randomisation sequence will be computer generated using random number generator software.
The sequence of 25 computer-generated numbers will be randomly allocated into intervention group. The remaining 25 will be included in the control group.
The allocation sequence will only be known by the principal researcher. The care provider and outcome assessors will be blinded from allocation sequences and intervention or control groups.
Intervention process
Preintervention trainings
Before the intervention, training of caregivers involved in enrolment and sending invitations to mothers for counselling, female doctor counselling and training mothers on breast feeding, nurse involved in counselling and training right after delivery, LHWs in community and outcomes data collectors will be done by principal researcher and a senior trained gynaecologist and obstetrician.
Hospital-based intervention
Participants in intervention group will be invited telephonically by a lady health visitor to come to ABSTH for breastfeeding counselling sessions and antenatal visit on a particular day with a female family member considered as her support (to assist and support mother at home).
Counselling by a trained female doctor in groups of 5–7 participant mothers with their family member for almost 40 min on ideal breastfeeding practices (benefits, latching, positions, myths, difficulties and discussion).
During first antenatal visits and at the time of discharge from the hospital after delivery, a booklet for participants and video recordings having similar content to counselling will be sent via WhatsApp on the cell number provided by participants.
After delivery in recovery room or ward, a trained nurse will assist in early initiation of breastfeed, hands on train on latching technique, feeding positions and emphasise on exclusive breast feeding till 6 months.
Community-based (at-home) intervention
After delivery in hospital and discharge when mother reaches home:
Trained LHW of the participant’s community will visit regularly on the following dates 0, 1, 2 weeks and 1, 3, 4 and 6 months after delivery to assist and support breast feeding (table 1).
Control group
The control group will receive the support already provided within the hospital by the staff and nurses and at home by community health workers and family.
Follow-up will be after 2 weeks, 1, 3 and 6 months of delivery as in intervention group to determine the outcomes of the routine care.
