ClinicalTrials.gg
CompletedNCT05951868Updated Nov 3, 2026

An Innovative Continuum of Care to Promote Exclusive Breastfeeding

An interventional study of Continuum of support on breastfeeding. in Breastfeeding, sponsored by Health Services Academy, Islamabad, Pakistan. Completed at 1 site in Pakistan. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Health Services Academy, Islamabad, Pakistan · Not applicable, Interventional, and Other

Updated Nov 3, 2026Now CompletedPrimary completion moved+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

  • Breastfeeding

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Keywords

  • exclusive breastfeeding
  • continuum of care
03

In context

Breast Feeding

1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 844 interventional studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

Health Services Academy, Islamabad, Pakistan is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Continuum of support on breastfeeding

    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.

  • No intervention
    Control group/Routine care

    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

  • BehavioralContinuum of support on breastfeeding.

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At 7th months after delivery

  2. 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.

    Time frame: At 7th months after delivery

  3. 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.

    Time frame: From enrolment to 7 months

Secondary outcomes

  1. Infant feeding status

    Telephonic follow up by research assistant of both intervention and control group mothers with a standard questionnaire using WHO indicators for assessing breastfeeding practices \& Survey form of feeding practices at 2 weeks, 1, 3, and 6 months and intentions beyond 6 months

    Time frame: At 2 weeks,1,3 & 6 months after delivery

  2. Iowa Infant Feeding Attitude Scale (IIFAS)

    Telephonic inquiry from participants via translation of Standard adopted 17 question scale form from both intervention and control group

    Time frame: After 1 months of delivery

  3. Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)

    Telephonic inquiry from participants via translation of Standard adopted 14-item scale form both intervention and control group

    Time frame: After 3 months of delivery

07

Study locations

1 site
  • Department of Gynaecology and Obstetrics Teaching Unit, Aziz Bhatti Shaheed Teaching hospital (ABSTH)
    Dhok Gujra, Punjab Province 50700, Pakistan
08

References and documents

Publications

  • 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. PubMed 38769049 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2023 to primary completion in Apr 2024, 9 months.

Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 9 months is below that.

Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2023
First posted
Jul 19, 2023
StartActual
Jul 6, 2023
Primary completionActual
Apr 30, 2024
CompletionActual
Apr 30, 2024
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Enrolling by invitation→Completed
changed Nov 3, 2026
Sites
1 site added, 1 site removed
Show site
  • Department of Gynaecology and Obstetrics Teaching Unit, Aziz Bhatti Shaheed Teaching hospital (ABSTH) · Dhok Gujra, Pakistan
Show 1 removed
  • Department of Gynaecology and Obstetrics Teaching Unit, Aziz Bhatti Shaheed Teaching hospital (ABSTH) · Gujrāt, Pakistan
Nov 3, 2026
Primary completion
Apr 15, 2024→Apr 30, 2024 (actual)
Nov 3, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 38769049 ↗
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Enrolling by invitation→Completed
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 38769049 ↗
    1 site added, 1 site removed
    Show site
    • Department of Gynaecology and Obstetrics Teaching Unit, Aziz Bhatti Shaheed Teaching hospital (ABSTH) · Dhok Gujra, Pakistan
    Show 1 removed
    • Department of Gynaecology and Obstetrics Teaching Unit, Aziz Bhatti Shaheed Teaching hospital (ABSTH) · Gujrāt, Pakistan
    Primary completion Apr 15, 2024→Apr 30, 2024 (now actual)
    + 4 other changes: verification date, description, design details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05951868
Lead sponsor
Health Services Academy, Islamabad, Pakistan
Responsible party
zahid azam chaudry (Doctor, Health Services Academy, Islamabad, Pakistan) — Principal investigator
First posted
Jul 19, 2023
Start date
Jul 6, 2023
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024
Last update
Nov 3, 2026

Study contacts

Zahid A Chaudry, MSPH
principal investigator · Department of Gynaecology and Obstetrics teaching unit, Aziz Bhatti Shaheed Teaching Hospital Gujrat

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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