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Home-based Breastfeeding Peer Counselling Programme

A Feasibility Randomised Controlled Study of an Innovative Postnatal Breastfeeding Peer Counselling Programme

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03705494
Enrollment
20
Registered
2018-10-15
Start date
2019-02-19
Completion date
2020-06-30
Last updated
2023-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

Keywords

Breastfeeding, Peer counsellor

Brief 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. 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).

Interventions

OTHERHome-based peer counselling (web-based) intervention

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.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Interventionthrough study completion, an average of 6 monthsThe 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.

Secondary

MeasureTime frameDescription
Number of Participants Who Exclusively BreastfeedAt 1, 2, 4 and 6 months postpartumThe number of participants who exclusive breastfeed at each follow-up time-points
Exclusive Breastfeeding DurationAt 1, 2, 4 and 6 months postpartumExclusive breastfeeding duration is measured using time in weeks
Women's Self-efficacy in BreastfeedingAt baseline, 2 and 4 months postpartumBreastfeeding 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.
Women's Attitude in BreastfeedingAt baseline, 2 and 4 months postpartumIowa 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).

Countries

Hong Kong

Participant flow

Participants by arm

ArmCount
Home-based Peer Counselling Intervention
Women planning to breastfeed who meet the study's inclusion criteria Home-based peer counselling intervention: The intervention consists of 5-6 home based visits 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.
10
Standard Usual Care
Women planning to breastfeed who meet the study's inclusion criteria
10
Total20

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up21
Overall StudyWithdrawal by Subject52

Baseline characteristics

CharacteristicStandard Usual CareHome-based Peer Counselling InterventionTotal
Age, Customized
18-24 years
0 Participants3 Participants3 Participants
Age, Customized
25-29 years
1 Participants1 Participants2 Participants
Age, Customized
30-34 years
6 Participants4 Participants10 Participants
Age, Customized
≥35 years
3 Participants2 Participants5 Participants
Attended antenatal breastfeeding class7 Participants7 Participants14 Participants
Attended antenatal childbirth class8 Participants8 Participants16 Participants
Length of residence in Hong Kong
≥15 years
9 Participants10 Participants19 Participants
Length of residence in Hong Kong
5-15 years
0 Participants0 Participants0 Participants
Length of residence in Hong Kong
<5 years
1 Participants0 Participants1 Participants
Maternal education
Compulsory Secondary
1 Participants0 Participants1 Participants
Maternal education
Post-graduate Degree
0 Participants1 Participants1 Participants
Maternal education
Post-secondary
4 Participants5 Participants9 Participants
Maternal education
Primary
0 Participants0 Participants0 Participants
Maternal education
University Degree
5 Participants4 Participants9 Participants
Monthly family income
<HK$15,000
1 Participants1 Participants2 Participants
Monthly family income
HK$15,000-29,999
1 Participants2 Participants3 Participants
Monthly family income
≥HK$30,000
8 Participants7 Participants15 Participants
Parity
Multiparous
2 Participants1 Participants3 Participants
Parity
Primiparous
8 Participants9 Participants17 Participants
Planned duration of breastfeeding
<6 months
0 Participants1 Participants1 Participants
Planned duration of breastfeeding
≥6 months
10 Participants9 Participants19 Participants
Planned to exclusively breastfeed8 Participants9 Participants17 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Hong Kong
10 Participants10 Participants20 Participants
Return to work postpartum
No or not sure
1 Participants3 Participants4 Participants
Return to work postpartum
Yes
9 Participants7 Participants16 Participants
Self-breastfed6 Participants4 Participants10 Participants
Sex: Female, Male
Female
10 Participants10 Participants20 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 10
other
Total, other adverse events
0 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 10

Outcome results

Primary

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.

Time frame: through study completion, an average of 6 months

Population: Participants in the intervention group who have received peer support intervention or completed the intervention

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Home-based Peer Counselling InterventionNumber of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding InterventionCompleted qualitative interview5 Participants
Home-based Peer Counselling InterventionNumber of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding InterventionNot completed qualitative interview1 Participants
Standard Usual CareNumber of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding InterventionCompleted qualitative interview0 Participants
Standard Usual CareNumber of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding InterventionNot completed qualitative interview0 Participants
Secondary

Exclusive Breastfeeding Duration

Exclusive breastfeeding duration is measured using time in weeks

Time frame: At 1, 2, 4 and 6 months postpartum

ArmMeasureValue (MEAN)Dispersion
Home-based Peer Counselling InterventionExclusive Breastfeeding Duration6.0 weeksStandard Deviation 9.1
Standard Usual CareExclusive Breastfeeding Duration4.7 weeksStandard Deviation 8
Secondary

Number of Participants Who Exclusively Breastfeed

The number of participants who exclusive breastfeed at each follow-up time-points

Time frame: At 1, 2, 4 and 6 months postpartum

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Home-based Peer Counselling InterventionNumber of Participants Who Exclusively Breastfeed1 month postpartum4 Participants
Home-based Peer Counselling InterventionNumber of Participants Who Exclusively Breastfeed2 months postpartum3 Participants
Home-based Peer Counselling InterventionNumber of Participants Who Exclusively Breastfeed4 months postpartum3 Participants
Home-based Peer Counselling InterventionNumber of Participants Who Exclusively Breastfeed6 months postpartum1 Participants
Standard Usual CareNumber of Participants Who Exclusively Breastfeed6 months postpartum1 Participants
Standard Usual CareNumber of Participants Who Exclusively Breastfeed1 month postpartum3 Participants
Standard Usual CareNumber of Participants Who Exclusively Breastfeed4 months postpartum3 Participants
Standard Usual CareNumber of Participants Who Exclusively Breastfeed2 months postpartum3 Participants
Secondary

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).

Time frame: At baseline, 2 and 4 months postpartum

Population: Cases lost to follow up or withdraw are not included

ArmMeasureGroupValue (MEAN)Dispersion
Home-based Peer Counselling InterventionWomen's Attitude in BreastfeedingBaseline66.2 score on a scaleStandard Deviation 6.2
Home-based Peer Counselling InterventionWomen's Attitude in Breastfeeding2 months postpartum59.3 score on a scaleStandard Deviation 7.3
Home-based Peer Counselling InterventionWomen's Attitude in Breastfeeding4 months postpartum61.5 score on a scaleStandard Deviation 6
Standard Usual CareWomen's Attitude in BreastfeedingBaseline61.5 score on a scaleStandard Deviation 5.2
Standard Usual CareWomen's Attitude in Breastfeeding2 months postpartum63.1 score on a scaleStandard Deviation 8.4
Standard Usual CareWomen's Attitude in Breastfeeding4 months postpartum66 score on a scaleStandard Deviation 7.3
Secondary

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.

Time frame: At baseline, 2 and 4 months postpartum

Population: Cases lost to follow-up or withdrew were not included in the follow-up assessments. Cases who were no longer breastfeeding at the time of follow-up were not also not included.

ArmMeasureGroupValue (MEAN)Dispersion
Home-based Peer Counselling InterventionWomen's Self-efficacy in BreastfeedingBaseline37.1 score on a scaleStandard Deviation 10.8
Home-based Peer Counselling InterventionWomen's Self-efficacy in Breastfeeding2 months postpartum45.3 score on a scaleStandard Deviation 12.7
Home-based Peer Counselling InterventionWomen's Self-efficacy in Breastfeeding4 months postpartum47.3 score on a scaleStandard Deviation 11.8
Standard Usual CareWomen's Self-efficacy in BreastfeedingBaseline44.5 score on a scaleStandard Deviation 5.9
Standard Usual CareWomen's Self-efficacy in Breastfeeding2 months postpartum46.6 score on a scaleStandard Deviation 13.2
Standard Usual CareWomen's Self-efficacy in Breastfeeding4 months postpartum57.5 score on a scaleStandard Deviation 13.7

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026