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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based peer counselling intervention | Active Comparator | Women 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based peer counselling (web-based) intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Exclusively Breastfeed | The number of participants who exclusive breastfeed at each follow-up time-points | At 1, 2, 4 and 6 months postpartum |
| Exclusive Breastfeeding Duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kris YW Dr Lok, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33849582 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard Usual Care | Women planning to breastfeed who meet the study's inclusion criteria |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants in the intervention group who have received peer support intervention or completed the intervention | Posted | Count of Participants | Participants | through study completion, an average of 6 months |
|
6 months or between participants' recruitment and exit the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kris LOK | The University of Hong Kong | 39176690 | krislok@hku.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2018 | Nov 4, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
Exclusive breastfeeding duration is measured using time in weeks
| 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. | 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). | At baseline, 2 and 4 months postpartum |
| BG001 |
| Standard Usual Care |
Women planning to breastfeed who meet the study's inclusion criteria |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Maternal education | Count of Participants | Participants |
|
| Monthly family income | Count of Participants | Participants |
|
| Length of residence in Hong Kong | Count of Participants | Participants |
|
| Return to work postpartum | Count of Participants | Participants |
|
| Parity | Count of Participants | Participants |
|
| Self-breastfed | Count of Participants | Participants |
|
| Attended antenatal childbirth class | Count of Participants | Participants |
|
| Attended antenatal breastfeeding class | Count of Participants | Participants |
|
| Planned to exclusively breastfeed | Count of Participants | Participants |
|
| Planned duration of breastfeeding | Count of Participants | Participants |
|
| OG001 | Standard Usual Care | Women planning to breastfeed who meet the study's inclusion criteria |
|
|
| Secondary | Number of Participants Who Exclusively Breastfeed | The number of participants who exclusive breastfeed at each follow-up time-points | Posted | Count of Participants | Participants | At 1, 2, 4 and 6 months postpartum |
|
|
|
| Secondary | Exclusive Breastfeeding Duration | Exclusive breastfeeding duration is measured using time in weeks | Posted | Mean | Standard Deviation | weeks | At 1, 2, 4 and 6 months postpartum |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | At baseline, 2 and 4 months postpartum |
|
|
|
| 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). | Cases lost to follow up or withdraw are not included | Posted | Mean | Standard Deviation | score on a scale | At baseline, 2 and 4 months postpartum |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Standard Usual Care | Women planning to breastfeed who meet the study's inclusion criteria | 0 | 10 | 0 | 10 | 0 | 10 |
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| Post-secondary |
|
| University Degree |
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| Post-graduate Degree |
|
| ≥HK$30,000 |
|
| ≥15 years |
|
| 4 months postpartum |
|
| 6 months postpartum |
|
| 2 months postpartum |
|
|
| 4 months postpartum |
|
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| 2 months postpartum |
|
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| 4 months postpartum |
|
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