Clinical trial NCT05951868: An Innovative Continuum of Care to Promote Exclusive Breastfeeding
Official title: An Innovative Continuum of Care to Promote Exclusive Breastfeeding in Pakistan:a Pilot Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breastfeeding
Keywords: exclusive breastfeeding
continuum of care
Lead sponsor: Health Services Academy, Islamabad, Pakistan
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Malnutrition and non optimal breastfeeding is one the the major cause of high infant morbidity and mortality in a developing country like Pakistan. In addition low women literacy rate,socioeconomic factors, cultural limitations,poor excess to information, misconceptions and other factors has led to low breastfeeding rates.

There has also been a shift over time from home based care and delivery to antenatal care from skilled providers and deliveries within health care facilities. Which is an opportunity to strengthen breastfeeding counselling to mothers starting from health facility where mothers come for antenatal visits and by utilising other modes of counselling within the health facility (which have weak or non-existing structured breast feeding program) and when mothers home till 6 months as a continuous support. Women from different backgrounds have opportunity to get excess to complete information on benefits,misconceptions and myths of breastfeeding which is understandable and acceptable by her, to enable her to make an informed decision to initiate early, exclusively breastfeed and to continue breastfeeding till 2 years or beyond.

The intervention group will receive interventions, will include a family member as a support for participant in her breastfeeding, 2 sessions of counselling on breastfeeding during participants antenatal visits,sharing of readable booklet \& video messages on Whats App application of cell phones about breastfeeding, hands on training by nurse after delivery, and continuum of support by multiple visits of lady health workers when the mothers home till 6 months. It will also include training of doctor,nurse \& lady health workers involved in the intervention.

The content of intervention will contain benefits \& ideal breastfeeding practices, latching \& feeding positions,expression \& storage of breast milk, associated myths \& difficulties with solutions in breastfeeding.

The control group participants will receive the routine support on breastfeeding given in hospital and in the community.

Feasibility, acceptability, cost effectiveness, sustainability and effectiveness of the intervention will be assessed.

Detailed description: Feeding of Infant and young child is a fundamental area to enhance child survival and promote its growth and development As per World Health Organisation (WHO) current global health observatory's data on developing country Pakistan, infant mortality of 53 per 1000 live births and under 5 mortality rate of 63 per 1000 live births is significantly due to malnutrition and non-optimal breast feeding practices.

With a shift to 86% women receiving Antenatal care from a skilled provider, 66% deliveries at health facilities, 69% births attended by skilled providers and 81% percent of births to urban mothers in a health facility..

Also keeping in mind literacy rates, socioeconomic factors, cultural limitations, skills of care providers, limited resource settings, local context, knowledge of mothers on breastfeeding and myths related to breastfeeding, it's an opportunity to initiate and strengthen a continuum of support breastfeeding program starting from hospitals (which have weak or non-existing structured breast feeding program) and extending to community when mothers are at home. In continuum of care program with multi component support interventions starting from antenatal period till 6 months postpartum need to be tested for its feasibility, acceptability, cost effectiveness, sustainability and effectiveness to improve exclusive breast feeding and timely weaning and continued breastfeeding until 2 years or beyond.

After recruitment of 50 women coming for their antenatal checkup as per inclusion/exclusion criteria and by informed consent. Demographic data will be collected and they will be randomly allocated into intervention and control groups.

Care providers involved in the intervention will be trained by a training session.

Intervention group Participants will be invited on next antenatal visits in the health facility;

1. Participants will be accompanied by a female family member of her choice considered as her support ( to encourage and assist mother at home on exclusively breast feeding and continuation of breastfeeding )
2. Participants will be counselled in groups of 5 to 7 in 2 sessions for 45- 60 minutes on benefits \& ideal breastfeeding practices, latching \& feeding positions, associated myths \& difficulties in breastfeeding, discussion and question answer session by a trained doctor in presence of a family member
3. To read Booklet will be given to participants and video recordings having same content as counselling session will be sent by Whats App during antenatal visits and at discharge.
4. At the time of delivery nurse will assist in skin to skin contact, early initiation, proper latching train on feeding positions and reemphasise on exclusive breast feeding.

After delivery and discharge of participant mother from hospital;

1. Trained Lady Health workers (LHWs) of the participant's catchment area will visit at 0,1,2 weeks 1,3,4 \& 6 months to reemphasise and support on already learned ideal breastfeeding practices.

The control group participants will receive the routine support on breastfeeding given in hospital and in the community.

Primary \& Secondary Outcomes will be measured by a semi structured questionnaire on telephonic call to participants

Eligibility criteria: Inclusion Criteria:

1. Age \>18years
2. Both nulliparous and multiparous
3. Is between 28-32 week gestation
4. Able to understand and communicate in Urdu/Punjabi
5. Plans her delivery at Aziz Bhatti Shaheed Teaching hospital (ABSTH) Gujrat
6. Has excess to smart phone and Whats App mobile application

Exclusion Criteria:

1. Lady Health Worker currently not present in mothers catchment area.
2. Not able to communicate verbally due to any reason.
3. Known medical conditions, congenital malformations or mental illness that may hinder in breastfeeding.

Primary outcomes:
measure: Feasibility of interventions
timeFrame: At 7th months after delivery
measure: Acceptability of interventions
timeFrame: At 7th months after delivery
measure: Extent to which the intervention is implemented as intended
timeFrame: From enrolment to 7 months
Secondary outcomes:
measure: Infant feeding status
timeFrame: At 2 weeks,1,3 & 6 months after delivery
measure: Iowa Infant Feeding Attitude Scale (IIFAS)
timeFrame: After 1 months of delivery
measure: Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
timeFrame: After 3 months of delivery
Other outcomes:
Locations:
city: Gujrāt
country: Pakistan
facility: Department of Gynaecology and Obstetrics Teaching Unit, Aziz Bhatti Shaheed Teaching hospital (ABSTH)
state: Punjab
Study officials:
affiliation: Department of Gynaecology and Obstetrics teaching unit, Aziz Bhatti Shaheed Teaching Hospital Gujrat
name: Zahid A Chaudry, MSPH
role: PRINCIPAL_INVESTIGATOR
References: