An Innovative Continuum of Care to Promote Exclusive Breastfeeding

NCT05951868 | Unknown

• 1 other identifier: 2226-HSA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding

Keywords

exclusive breastfeeding; continuum of care

Outcome Measures

Primary Outcomes (3)

• Feasibility of interventions

  The feasibility of the intervention will be assessed through a semi-structured questionnaire administered to all participants and care providers after 6 months of delivery. The questionnaire will evaluate the practicality and ease of implementing the intervention.

  At 7th months after delivery

• Acceptability of interventions

  The acceptability of the intervention will be determined through a semi-structured questionnaire administered to all participants and care providers after 6 months of delivery. The questionnaire will explore the participants' and providers' satisfaction, comfort, and willingness to continue with the intervention.

  At 7th months after delivery

• Extent to which the intervention is implemented as intended

  From enrolment till the last intervention a Performa of every activity ; showing number of participants, day, time, duration, checklist of all the components of intervention delivered and signed by intervention provider on the day of activity with a pictorial evidence sent via Whats App to central record. Feedback from participants on the same checklists of all the components of intervention delivered will also be taken at end of the intervention by an independent researcher.

  From enrolment to 7 months

Secondary Outcomes (3)

• Infant feeding status

  At 2 weeks,1,3 & 6 months after delivery

• Iowa Infant Feeding Attitude Scale (IIFAS)

  After 1 months of delivery

• Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)

  After 3 months of delivery

Study Arms (2)

Continuum of support on breastfeeding

EXPERIMENTAL

Content of counselling intervention will be on ideal breast feeding practices,benefits of breastfeeding, weaning, myths \& common problems faced during breastfeeding with their solutions,Latching techniques,feeding positions, ways to express milk \& storage techniques. Discussion and Q\&A session 1. Women with her female family member of support invited for antenatal visit will be counselled by a trained doctor on breastfeeding in 2 -sessions between 32 \& 40 weeks of gestation. 2. Readable booklet \& whats app videos having same content in local Urdu language will be shared with the women during antenatal visit and at discharge from hospital. 3. At time of delivery skin to skin contact, early initiation, proper latching ,positioning and reemphasising on exclusive breastfeeding done by a trained nurse. 4. Follow up by trained community lady health workers to visit mothers home to reinforce learned information and support mothers at 0,1,2 weeks \& 1,3,4,6 months

Behavioral: Continuum of support on breastfeeding.

Control group/Routine care

NO INTERVENTION

The control group will receive routine care in terms of routine counselling done on breastfeeding in the hospital \& when mothers at home by lady health workers.

Interventions

Continuum of support on breastfeeding. BEHAVIORAL

A continuous support program for women from antenatal period till 6 months after delivery to initiate early breastfeeding, exclusively breastfeeding for 6 month and to continue breastfeeding till 2 years and beyond.

Continuum of support on breastfeeding

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Health Services Academy, Islamabad, Pakistan: lead

Study Sites (1)

Department of Gynaecology and Obstetrics Teaching Unit, Aziz Bhatti Shaheed Teaching hospital (ABSTH)

Dhok Gujra, Punjab Province, 50700, Pakistan

Location

Related Publications (1)

• Chaudry ZA, Naz T, Arshad I, Zahoor A, Javaid M, Sikander S. Innovative continuum of care to promote exclusive breast feeding in Pakistan: protocol of a pilot randomised controlled trial. BMJ Paediatr Open. 2024 May 20;8(1):e002562. doi: 10.1136/bmjpo-2024-002562.

  PMID: 38769049 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Zahid A Chaudry, MSPH

  Department of Gynaecology and Obstetrics teaching unit, Aziz Bhatti Shaheed Teaching Hospital Gujrat

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 19, 2023
• Study Start: July 6, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 30, 2024
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)