BreastfeedingNCT03705494
Home-based Breastfeeding Peer Counselling Programme
A study testing Home-based peer counselling (web-based) intervention in people with Breastfeeding, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
A feasibility study is proposed in the current study as women who had given birth to their first babies recruited to a previous project specifically expressed the need for postnatal breastfeeding support from peer counsellors at home and there is evidence that this could be of benefit for women and their infants. 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?
- Home-based peer counselling (web-based) intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 19 Feb 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Primiparous mothers
- Intention to breastfeed
- Singleton pregnancy
- Term infant (37-42 weeks gestational)
- Cantonese speaking
- Hong Kong resident
- Mother with no serious medical or obstetrical complications.
Who cannot join
- infant is <37 weeks gestation,
- infant has an Apgar score <8 at five minutes,
- infant has a birthweight <2500 grams,
- infant has any severe medical conditions or congenital malformations
- infant is placed in the special care baby unit for more than 48 hours after birth
- infant is placed in the neonatal intensive care unit at any time after birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Randomised Controlled Study of an Innovative Postnatal Breastfeeding Peer Counselling Programme
A feasibility study is proposed in the current study as women who had given birth to their first babies recruited to a previous project specifically expressed the need for postnatal breastfeeding support from peer counsellors at home and there is evidence that this could be of benefit for women and their infants. Evidence of whether women in Hong Kong who had peer counsellors have better breastfeeding outcomes compared to women who had standard care however is not available. Prior to undertaking a definitive trial, the investigators need to know if women would be willing to be recruited and randomised to an intervention or standard care.
Read the detailed description
Peer counselling and support has been shown to be effective in improving breastfeeding (BF) initiation, duration and exclusiveness. Peer counselling is being introduced into different country settings worldwide as an intervention to support women to achieve successful commencement and maintenance of breastfeeding, given the range of health benefits for the woman and her infant. Findings from one Cochrane review suggested that postnatal contacts in the home may reduce infant health service utilisation in the weeks following the birth, and that more home visits may encourage more women to exclusively breastfeed.
The planned study A feasibility randomized controlled trial (RCT) study is proposed in the current study as women who had given birth to their first babies recruited to a previous project specifically expressed the need for postnatal BF support from peer counsellors at home and there is evidence that this could be of benefit for women and their infants. Evidence of whether women in Hong Kong who had peer counsellors have better breastfeeding outcomes compared to women who had standard care however is not available. Prior to undertaking a definitive RCT, the investigators need to know if women would be willing to be recruited and randomised to an intervention or standard care.
This study is important for several reasons. Chinese women are expected to be housebound during the first month postnatally due to the tradition of 'doing the month', when problems with infant feeding and/or infants failing to thrive due to poor feeding could result in a decision to stop breastfeeding. The innovative home-based intervention the investigators will undertake will address an important service gap in Hong Kong to promote and sustain exclusive breastfeeding, and could be an effective strategy which reflects Chinese culture. The Health Care and Promotion Scheme grant review panel recommended that although an evaluation of a home-based peer counselling project is a high priority, a small-scale feasibility study was needed before a definitive RCT application is submitted.
Peer counsellors will be recruited from those who passed the UNICEF and La Leche League Peer Counselling Training programme. Additional training tailored to issues that they may encounter in home-based contacts with women who are breastfeeding, for example solving problems of exclusive breastfeeding and correct breastfeeding technique will be needed and conducted by team leaders for the peer counsellors. Women planning to breastfeed who meet the study's inclusion criteria will be recruited from hospital postnatal ward and randomly allocated using opaque, sealed envelopes, by an independent research assistant not involved in participant recruitment, data collection or analysis to the intervention group (n=10, home-based peer counselling intervention and standard usual care) and control groups (n=10, standard usual care).
- Conditions
- Breastfeeding
- Being tested
- Home-based peer counselling (web-based) intervention
- Keywords
- Breastfeeding, Peer counsellor
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based peer counselling (web-based) interventionOther
The intervention consists of 5-6 home based visits (web-based) over 6 months by trained peer counsellors who will focus on breastfeeding among mothers who have already decided to breastfeed and are interested in this programme.
| Study group | Role | What they receive |
|---|---|---|
| Home-based peer counselling intervention | Active comparator | Women planning to breastfeed who meet the study's inclusion criteria Receives: Other: Home-based peer counselling (web-based) intervention |
| Standard usual care | No intervention | Women planning to breastfeed who meet the study's inclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention
The number of participants who have completed the in-depth qualitative interviews on their views on the peer counselling breastfeeding intervention programme.
Participants who are in the intervention group and have received intervention were approached for qualitative interviews after study completion at six months. Eight participants have received intervention, two of which has been lost to follow-up. Thus, six participants were approached for the interview. One participants refused to be interviewed.
Measured: through study completion, an average of 6 months
Secondary outcomes (4)
Number of Participants Who Exclusively Breastfeed
The number of participants who exclusive breastfeed at each follow-up time-points
Measured: At 1, 2, 4 and 6 months postpartum
Exclusive Breastfeeding Duration
Exclusive breastfeeding duration is measured using time in weeks
Measured: At 1, 2, 4 and 6 months postpartum
Women's Self-efficacy in Breastfeeding
Breastfeeding Self-efficacy Scale measures maternal breastfeeding self-efficacy. It consists of 14 items measured on a 5-point likert scale. On scale 1 indicates "not at all confident" and 5 indicates "always confident". Total scores range from 14 to 70 with higher scores indicating greater breastfeeding confidence and self-efficacy.
Measured: At baseline, 2 and 4 months postpartum
Women's Attitude in Breastfeeding
Iowa Infant Feeding Attitude Scale is a measure of attitudes towards feeding. It consists of 17 items that are scored on a 5-point Likert scale, which ranges from 1 (strongly disagree) to 5 (strongly agree). Eight items are worded in a favourable manner towards breastfeeding, while nine are favourable towards formula feeding. Items favouring formula feeding are reverse-scored (i.e. 1=5, 2=4, 4=2 and 5=1). The total attitude scores range from 17 (indicating positive bottle feeding attitudes) to 85 (reflecting positive breastfeeding attitudes). Total scores are grouped into the following three categories: (1) positive towards breastfeeding (70-85); (2) neutral (49-69); and (3) positive towards formula feeding (17-48).
Measured: At baseline, 2 and 4 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start19 Feb 2019
- Primary completion1 Oct 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kris YW Dr Lok, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705494
- Sponsor's protocol ID
- BFPC1
- Status last verified
- Sep 2019
- First submitted
- 2 Sep 2018
- Last updated
- 6 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lok KY, Chow CLY, Shing JSY, Smith R, Lam CCO, Bick D, Chang YS. Feasibility, acceptability, and potential efficacy of an innovative postnatal home-based breastfeeding peer support programme in Hong Kong: a feasibility and pilot randomised controlled trial. Int Breastfeed J. 2021 Apr 13;16(1):34. doi: 10.1186/s13006-021-00381-5.
PubMed 33849582
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomised Controlled Study of an Innovative Postnatal Breastfeeding Peer Counselling Programme
- ClinicalTrials.gov ID
- NCT03705494
- Acronym / sponsor ID
- BFPC1
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding, Peer counsellor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 24 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A feasibility study is proposed in the current study as women who had given birth to their first babies recruited to a previous project specifically expressed the need for postnatal breastfeeding support from peer counsellors at home and there is evidence that this could be of benefit for women and their infants. Evidence of whether women in Hong Kong who had peer counsellors have better breastfeeding outcomes compared to women who had standard care however is not available. Prior to undertaking a definitive trial, the investigators need to know if women would be willing to be recruited and randomised to an intervention or standard care.
Detailed description
Peer counselling and support has been shown to be effective in improving breastfeeding (BF) initiation, duration and exclusiveness. Peer counselling is being introduced into different country settings worldwide as an intervention to support women to achieve successful commencement and maintenance of breastfeeding, given the range of health benefits for the woman and her infant. Findings from one Cochrane review suggested that postnatal contacts in the home may reduce infant health service utilisation in the weeks following the birth, and that more home visits may encourage more women to exclusively breastfeed.
The planned study A feasibility randomized controlled trial (RCT) study is proposed in the current study as women who had given birth to their first babies recruited to a previous project specifically expressed the need for postnatal BF support from peer counsellors at home and there is evidence that this could be of benefit for women and their infants. Evidence of whether women in Hong Kong who had peer counsellors have better breastfeeding outcomes compared to women who had standard care however is not available. Prior to undertaking a definitive RCT, the investigators need to know if women would be willing to be recruited and randomised to an intervention or standard care.
This study is important for several reasons. Chinese women are expected to be housebound during the first month postnatally due to the tradition of 'doing the month', when problems with infant feeding and/or infants failing to thrive due to poor feeding could result in a decision to stop breastfeeding. The innovative home-based intervention the investigators will undertake will address an important service gap in Hong Kong to promote and sustain exclusive breastfeeding, and could be an effective strategy which reflects Chinese culture. The Health Care and Promotion Scheme grant review panel recommended that although an evaluation of a home-based peer counselling project is a high priority, a small-scale feasibility study was needed before a definitive RCT application is submitted.
Peer counsellors will be recruited from those who passed the UNICEF and La Leche League Peer Counselling Training programme. Additional training tailored to issues that they may encounter in home-based contacts with women who are breastfeeding, for example solving problems of exclusive breastfeeding and correct breastfeeding technique will be needed and conducted by team leaders for the peer counsellors. Women planning to breastfeed who meet the study's inclusion criteria will be recruited from hospital postnatal ward and randomly allocated using opaque, sealed envelopes, by an independent research assistant not involved in participant recruitment, data collection or analysis to the intervention group (n=10, home-based peer counselling intervention and standard usual care) and control groups (n=10, standard usual care).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based peer counselling intervention | Active comparator | Other: Home-based peer counselling (web-based) interventionWomen planning to breastfeed who meet the study's inclusion criteria |
| Standard usual care | No intervention | –Women planning to breastfeed who meet the study's inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primiparous mothers
- Intention to breastfeed
- Singleton pregnancy
- Term infant (37-42 weeks gestational)
- Cantonese speaking
Key exclusion criteria (6 listed)
- infant is <37 weeks gestation,
- infant has an Apgar score <8 at five minutes,
- infant has a birthweight <2500 grams,
- infant has any severe medical conditions or congenital malformations
- infant is placed in the special care baby unit for more than 48 hours after birth
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 |
|---|---|---|
| Home-based peer counselling (web-based) interventionThe intervention consists of 5-6 home based visits (web-based) over 6 months by trained peer counsellors who will focus on breastfeeding among mothers who have already decided to breastfeed and are interested in this programme. | Other | Home-based peer counselling intervention |
Primary outcome
Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention
Time frame: through study completion, an average of 6 months
The number of participants who have completed the in-depth qualitative interviews on their views on the peer counselling breastfeeding intervention programme. Participants who are in the intervention group and have received intervention were approached for qualitative interviews after study completion at six months. Eight participants have received intervention, two of which has been lost to follow-up. Thus, six participants were approached for the interview. One participants refused to be interviewed.
4 secondary outcomes
Number of Participants Who Exclusively Breastfeed
Time frame: At 1, 2, 4 and 6 months postpartum
Exclusive Breastfeeding Duration
Time frame: At 1, 2, 4 and 6 months postpartum
Women's Self-efficacy in Breastfeeding
Time frame: At baseline, 2 and 4 months postpartum
Women's Attitude in Breastfeeding
Time frame: At baseline, 2 and 4 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33849582Lok KY, Chow CLY, Shing JSY, Smith R, Lam CCO, Bick D, Chang YS. Feasibility, acceptability, and potential efficacy of an innovative postnatal home-based breastfeeding peer support programme in Hong Kong: a feasibility and pilot randomised controlled trial. Int Breastfeed J. 2021 Apr 13;16(1):34. doi: 10.1186/s13006-021-00381-5.
- Individual participant dataSharing planned: No
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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.
Kris YW Dr Lok, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based peer counselling (web-based) intervention in people with Breastfeeding, run by The University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 6 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 6 Jun 2023. 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 Hong Kong. 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?
Yes. Results are posted in the registry (first posted 24 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention (time frame: through study completion, an average of 6 months). 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 NCT03705494, 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 6 Jun 2023.