Trial Outcomes & Findings for Home-based Breastfeeding Peer Counselling Programme (NCT NCT03705494)
NCT ID: NCT03705494
Last Updated: 2023-06-06
Results Overview
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.
COMPLETED
NA
20 participants
through study completion, an average of 6 months
2023-06-06
Participant Flow
Participant milestones
| Measure |
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.
|
Standard Usual Care
Women planning to breastfeed who meet the study's inclusion criteria
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
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.
|
Standard Usual Care
Women planning to breastfeed who meet the study's inclusion criteria
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Home-based Peer Counselling Intervention
n=10 Participants
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.
|
Standard Usual Care
n=10 Participants
Women planning to breastfeed who meet the study's inclusion criteria
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-24 years
|
3 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
|
Age, Customized
25-29 years
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Age, Customized
30-34 years
|
4 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
|
Age, Customized
≥35 years
|
2 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Hong Kong
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
|
Maternal education
Primary
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Maternal education
Compulsory Secondary
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Maternal education
Post-secondary
|
5 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
|
Maternal education
University Degree
|
4 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
|
Maternal education
Post-graduate Degree
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Monthly family income
<HK$15,000
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Monthly family income
HK$15,000-29,999
|
2 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
|
Monthly family income
≥HK$30,000
|
7 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
15 Participants
n=20 Participants
|
|
Length of residence in Hong Kong
<5 years
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Length of residence in Hong Kong
5-15 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Length of residence in Hong Kong
≥15 years
|
10 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
|
Return to work postpartum
No or not sure
|
3 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
|
Return to work postpartum
Yes
|
7 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
16 Participants
n=20 Participants
|
|
Parity
Primiparous
|
9 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
17 Participants
n=20 Participants
|
|
Parity
Multiparous
|
1 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
|
Self-breastfed
|
4 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
10 Participants
n=20 Participants
|
|
Attended antenatal childbirth class
|
8 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
16 Participants
n=20 Participants
|
|
Attended antenatal breastfeeding class
|
7 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
14 Participants
n=20 Participants
|
|
Planned to exclusively breastfeed
|
9 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
17 Participants
n=20 Participants
|
|
Planned duration of breastfeeding
<6 months
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Planned duration of breastfeeding
≥6 months
|
9 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
19 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Participants in the intervention group who have received peer support intervention or completed the 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.
Outcome measures
| Measure |
Home-based Peer Counselling Intervention
n=6 Participants
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.
|
Standard Usual Care
Women planning to breastfeed who meet the study's inclusion criteria
|
|---|---|---|
|
Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention
Completed qualitative interview
|
5 Participants
|
0 Participants
|
|
Number of Participants Completing Qualitative Interviews on the Peer Counselling Breastfeeding Intervention
Not completed qualitative interview
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 1, 2, 4 and 6 months postpartumThe number of participants who exclusive breastfeed at each follow-up time-points
Outcome measures
| Measure |
Home-based Peer Counselling Intervention
n=10 Participants
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.
|
Standard Usual Care
n=10 Participants
Women planning to breastfeed who meet the study's inclusion criteria
|
|---|---|---|
|
Number of Participants Who Exclusively Breastfeed
1 month postpartum
|
4 Participants
|
3 Participants
|
|
Number of Participants Who Exclusively Breastfeed
2 months postpartum
|
3 Participants
|
3 Participants
|
|
Number of Participants Who Exclusively Breastfeed
4 months postpartum
|
3 Participants
|
3 Participants
|
|
Number of Participants Who Exclusively Breastfeed
6 months postpartum
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At 1, 2, 4 and 6 months postpartumExclusive breastfeeding duration is measured using time in weeks
Outcome measures
| Measure |
Home-based Peer Counselling Intervention
n=10 Participants
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.
|
Standard Usual Care
n=10 Participants
Women planning to breastfeed who meet the study's inclusion criteria
|
|---|---|---|
|
Exclusive Breastfeeding Duration
|
6.0 weeks
Standard Deviation 9.1
|
4.7 weeks
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: At baseline, 2 and 4 months postpartumPopulation: 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.
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.
Outcome measures
| Measure |
Home-based Peer Counselling Intervention
n=10 Participants
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.
|
Standard Usual Care
n=10 Participants
Women planning to breastfeed who meet the study's inclusion criteria
|
|---|---|---|
|
Women's Self-efficacy in Breastfeeding
Baseline
|
37.1 score on a scale
Standard Deviation 10.8
|
44.5 score on a scale
Standard Deviation 5.9
|
|
Women's Self-efficacy in Breastfeeding
2 months postpartum
|
45.3 score on a scale
Standard Deviation 12.7
|
46.6 score on a scale
Standard Deviation 13.2
|
|
Women's Self-efficacy in Breastfeeding
4 months postpartum
|
47.3 score on a scale
Standard Deviation 11.8
|
57.5 score on a scale
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: At baseline, 2 and 4 months postpartumPopulation: Cases lost to follow up or withdraw are not included
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).
Outcome measures
| Measure |
Home-based Peer Counselling Intervention
n=10 Participants
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.
|
Standard Usual Care
n=10 Participants
Women planning to breastfeed who meet the study's inclusion criteria
|
|---|---|---|
|
Women's Attitude in Breastfeeding
Baseline
|
66.2 score on a scale
Standard Deviation 6.2
|
61.5 score on a scale
Standard Deviation 5.2
|
|
Women's Attitude in Breastfeeding
2 months postpartum
|
59.3 score on a scale
Standard Deviation 7.3
|
63.1 score on a scale
Standard Deviation 8.4
|
|
Women's Attitude in Breastfeeding
4 months postpartum
|
61.5 score on a scale
Standard Deviation 6.0
|
66 score on a scale
Standard Deviation 7.3
|
Adverse Events
Home-based Peer Counselling Intervention
Standard Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place