Breastfeeding
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Exclusively Breastfeed | At 1, 2, 4 and 6 months postpartum | The number of participants who exclusive breastfeed at each follow-up time-points |
| Exclusive Breastfeeding Duration | At 1, 2, 4 and 6 months postpartum | Exclusive breastfeeding duration is measured using time in weeks |
| Women's Self-efficacy in Breastfeeding | At baseline, 2 and 4 months postpartum | 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. |
| Women's Attitude in Breastfeeding | At baseline, 2 and 4 months postpartum | 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). |
Countries
Hong Kong
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 2 |
Baseline characteristics
| Characteristic | Standard Usual Care | Home-based Peer Counselling Intervention | Total |
|---|---|---|---|
| Age, Customized 18-24 years | 0 Participants | 3 Participants | 3 Participants |
| Age, Customized 25-29 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized 30-34 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Customized ≥35 years | 3 Participants | 2 Participants | 5 Participants |
| Attended antenatal breastfeeding class | 7 Participants | 7 Participants | 14 Participants |
| Attended antenatal childbirth class | 8 Participants | 8 Participants | 16 Participants |
| Length of residence in Hong Kong ≥15 years | 9 Participants | 10 Participants | 19 Participants |
| Length of residence in Hong Kong 5-15 years | 0 Participants | 0 Participants | 0 Participants |
| Length of residence in Hong Kong <5 years | 1 Participants | 0 Participants | 1 Participants |
| Maternal education Compulsory Secondary | 1 Participants | 0 Participants | 1 Participants |
| Maternal education Post-graduate Degree | 0 Participants | 1 Participants | 1 Participants |
| Maternal education Post-secondary | 4 Participants | 5 Participants | 9 Participants |
| Maternal education Primary | 0 Participants | 0 Participants | 0 Participants |
| Maternal education University Degree | 5 Participants | 4 Participants | 9 Participants |
| Monthly family income <HK$15,000 | 1 Participants | 1 Participants | 2 Participants |
| Monthly family income HK$15,000-29,999 | 1 Participants | 2 Participants | 3 Participants |
| Monthly family income ≥HK$30,000 | 8 Participants | 7 Participants | 15 Participants |
| Parity Multiparous | 2 Participants | 1 Participants | 3 Participants |
| Parity Primiparous | 8 Participants | 9 Participants | 17 Participants |
| Planned duration of breastfeeding <6 months | 0 Participants | 1 Participants | 1 Participants |
| Planned duration of breastfeeding ≥6 months | 10 Participants | 9 Participants | 19 Participants |
| Planned to exclusively breastfeed | 8 Participants | 9 Participants | 17 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Hong Kong | 10 Participants | 10 Participants | 20 Participants |
| Return to work postpartum No or not sure | 1 Participants | 3 Participants | 4 Participants |
| Return to work postpartum Yes | 9 Participants | 7 Participants | 16 Participants |
| Self-breastfed | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Home-based Peer Counselling Intervention | Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention | Completed qualitative interview | 5 Participants |
| Home-based Peer Counselling Intervention | Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention | Not completed qualitative interview | 1 Participants |
| Standard Usual Care | Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention | Completed qualitative interview | 0 Participants |
| Standard Usual Care | Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention | Not completed qualitative interview | 0 Participants |
Exclusive Breastfeeding Duration
Exclusive breastfeeding duration is measured using time in weeks
Time frame: At 1, 2, 4 and 6 months postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Home-based Peer Counselling Intervention | Exclusive Breastfeeding Duration | 6.0 weeks | Standard Deviation 9.1 |
| Standard Usual Care | Exclusive Breastfeeding Duration | 4.7 weeks | Standard Deviation 8 |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Home-based Peer Counselling Intervention | Number of Participants Who Exclusively Breastfeed | 1 month postpartum | 4 Participants |
| Home-based Peer Counselling Intervention | Number of Participants Who Exclusively Breastfeed | 2 months postpartum | 3 Participants |
| Home-based Peer Counselling Intervention | Number of Participants Who Exclusively Breastfeed | 4 months postpartum | 3 Participants |
| Home-based Peer Counselling Intervention | Number of Participants Who Exclusively Breastfeed | 6 months postpartum | 1 Participants |
| Standard Usual Care | Number of Participants Who Exclusively Breastfeed | 6 months postpartum | 1 Participants |
| Standard Usual Care | Number of Participants Who Exclusively Breastfeed | 1 month postpartum | 3 Participants |
| Standard Usual Care | Number of Participants Who Exclusively Breastfeed | 4 months postpartum | 3 Participants |
| Standard Usual Care | Number of Participants Who Exclusively Breastfeed | 2 months postpartum | 3 Participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home-based Peer Counselling Intervention | Women's Attitude in Breastfeeding | Baseline | 66.2 score on a scale | Standard Deviation 6.2 |
| Home-based Peer Counselling Intervention | Women's Attitude in Breastfeeding | 2 months postpartum | 59.3 score on a scale | Standard Deviation 7.3 |
| Home-based Peer Counselling Intervention | Women's Attitude in Breastfeeding | 4 months postpartum | 61.5 score on a scale | Standard Deviation 6 |
| Standard Usual Care | Women's Attitude in Breastfeeding | Baseline | 61.5 score on a scale | Standard Deviation 5.2 |
| Standard Usual Care | Women's Attitude in Breastfeeding | 2 months postpartum | 63.1 score on a scale | Standard Deviation 8.4 |
| Standard Usual Care | Women's Attitude in Breastfeeding | 4 months postpartum | 66 score on a scale | Standard Deviation 7.3 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home-based Peer Counselling Intervention | Women's Self-efficacy in Breastfeeding | Baseline | 37.1 score on a scale | Standard Deviation 10.8 |
| Home-based Peer Counselling Intervention | Women's Self-efficacy in Breastfeeding | 2 months postpartum | 45.3 score on a scale | Standard Deviation 12.7 |
| Home-based Peer Counselling Intervention | Women's Self-efficacy in Breastfeeding | 4 months postpartum | 47.3 score on a scale | Standard Deviation 11.8 |
| Standard Usual Care | Women's Self-efficacy in Breastfeeding | Baseline | 44.5 score on a scale | Standard Deviation 5.9 |
| Standard Usual Care | Women's Self-efficacy in Breastfeeding | 2 months postpartum | 46.6 score on a scale | Standard Deviation 13.2 |
| Standard Usual Care | Women's Self-efficacy in Breastfeeding | 4 months postpartum | 57.5 score on a scale | Standard Deviation 13.7 |