BreastfeedingNCT05951868
An Innovative Continuum of Care to Promote Exclusive Breastfeeding
A study testing Continuum of support on breastfeeding. in people with Breastfeeding, run by Health Services Academy, Islamabad, Pakistan at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Continuum of support on breastfeeding.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Jul 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Gynaecology and Obstetrics Teaching Unit, Aziz Bhatti Shaheed Teaching hospital (ABSTH)
Dhok Gujra, Punjab Province, 50700
About this study
Official title: An Innovative Continuum of Care to Promote Exclusive Breastfeeding in Pakistan:a Pilot Randomised Control Trial
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.
Read more
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;
- 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 )
- 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
- 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.
- 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;
- 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
- Conditions
- Breastfeeding
- Being tested
- Continuum of support on breastfeeding.
- Keywords
- exclusive breastfeeding, continuum of care
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuum of support on breastfeeding.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrolment to 7 months
Secondary outcomes (3)
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
Measured: At 2 weeks,1,3 & 6 months after delivery
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
Measured: After 1 months of delivery
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
Measured: After 3 months of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start6 Jul 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Services Academy, Islamabad, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zahid azam chaudry, Health Services Academy, Islamabad, Pakistan
- Investigators
- Zahid A Chaudry, MSPH, Principal investigator, Department of Gynaecology and Obstetrics teaching unit, Aziz Bhatti Shaheed Teaching Hospital Gujrat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951868
- Sponsor's protocol ID
- 2226-HSA
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Continuum of Care to Promote Exclusive Breastfeeding in Pakistan:a Pilot Randomised Control Trial
- ClinicalTrials.gov ID
- NCT05951868
- Acronym / sponsor ID
- 2226-HSA
- Conditions
- Breastfeeding
- Keywords
- exclusive breastfeeding, continuum of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Health Services Academy, Islamabad, PakistanUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- 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 )
- 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
- 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.
- 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;
- 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuum of support on breastfeeding | Experimental | Behavioral: 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuum 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. | Behavioural | Continuum of support on breastfeeding |
Primary outcome
Feasibility of interventions
Time frame: At 7th months after delivery
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.
Acceptability of interventions
Time frame: At 7th months after delivery
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.
Extent to which the intervention is implemented as intended
Time frame: From enrolment to 7 months
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.
3 secondary outcomes
Infant feeding status
Time frame: At 2 weeks,1,3 & 6 months after delivery
Iowa Infant Feeding Attitude Scale (IIFAS)
Time frame: After 1 months of delivery
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
Time frame: After 3 months of delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 38769049Chaudry 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.
- Individual participant dataSharing planned: No
Related trials for Breastfeeding
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahid A Chaudry, MSPH principal investigator
Department of Gynaecology and Obstetrics teaching unit, Aziz Bhatti Shaheed Teaching Hospital Gujrat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuum of support on breastfeeding. in people with Breastfeeding, run by Health Services Academy, Islamabad, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of interventions (time frame: At 7th months after delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05951868, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.