Effectiveness of interventions in improving continued exclusive breastfeeding in Brunei Darussalam
| ISRCTN | ISRCTN55245820 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55245820 |
- Submission date
- 28/04/2021
- Registration date
- 24/05/2021
- Last edited
- 11/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Despite the known benefits of breastfeeding for both infants and mothers, the rates of exclusive breastfeeding in Brunei Darussalam remains suboptimal. This study is a single-blinded randomised controlled trial that aims to evaluate effectiveness of antenatal breastfeeding workshop and postpartum brief motivational intervention in improving primiparous mother's exclusive breastfeeding practice.
Who can participate?
First-time pregnant women who are above 18 years old with no medical conditions that require medications can participate in this trial.
What does the study involve?
These women who attend their antenatal health educational talks at Gadong and Berakas Maternal Child Health Clinics in Brunei will be randomly assigned to either the intervention group (breastfeeding workshop and brief motivational intervention) or the control group (breastfeeding workshop only). They are then followed up until six months after their infant is born to assess their exclusive breastfeeding practice.
What are the possible benefits and risks of participating?
There are no risks to participants for joining this trial and there are no direct financial or other benefits for participants.
Where is the study run from?
Ministry of Health (Brunei)
When is the study starting and how long is it expected to run for?
October 2020 to December 2023
Who is funding the study?
Ministry of Health (Brunei)
Who is the main contact?
Dr Faezah Amin, faezah.amin@moh.gov.bn
Contact information
Scientific
Ministry of Health
Commonwealth Drive
Bandar Seri Begawan
BB3900
Brunei Darussalam
| Phone | +673 (0)8305515 |
|---|---|
| faezah.amin@moh.gov.bn |
Scientific
Health Promotion Centre
Ministry of Health
Commonwealth Drive
Bandar Seri Begawan
BB3900
Brunei Darussalam
 ORCID ID |
0000-0002-1026-8401 |
|---|---|
| Phone | +673 (0)238 5800 |
| lubna.razak@moh.gov.bn |
Study information
| Study design | Single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | ISRCTN55245820_PIS.pdf |
| Scientific title | A single-blinded randomised controlled trial to assess the effectiveness of an antenatal breastfeeding workshop and postnatal brief motivational intervention in improving continued exclusive breastfeeding in the first 6 months among primiparous mothers |
| Study objectives | Interventions of antenatal breastfeeding workshop and postnatal brief motivational intervention are effective at improving exclusive breastfeeding (EBF) rates for infants less than 6 months among primiparous mothers. |
| Ethics approval(s) | Approved 27/01/2021, Medical and Health Research & Ethics Committee (MHREC Executive Screening Suite, Basement Carpak Level 1, Raja Isteri Pengiran Anak Saleha Hospital, Bandar Seri Begawan BA1710, Negara Brunei Darussalam, Brunei; +673-2381640; mhrec@moh.gov.bn), ref: MRHEC/MOH/2020/20(1) |
| Health condition(s) or problem(s) studied | Exclusive breastfeeding among primiparous mothers |
| Intervention | First-time pregnant women are recruited during their routine antenatal health educational talk at two maternal and child health centres. Those who fit the eligibility criteria are then assigned randomly into either control or intervention groups with a 1:1 allocation as per a computer generated randomization schedule stratified by site using permuted blocks of random sizes.* The block sizes will not be disclosed, to ensure concealment. 1. Intervention group: In addition to the routine care, first-time mothers assigned to the intervention group will be invited to attend antenatal breastfeeding workshop. They will also receive a 15-minute Brief Motivational Intervention (BMI) via phone call at the first and third month postpartum. 2. Control group: In addition to the routine care, first-time mothers assigned to this group will be invited to the antenatal breastfeeding workshop in addition the routine care. They will however not receive any BMI via phone call postpartum. *Sealed Envelope Ltd. 2021. Simple randomisation service. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/ [Accessed 6 May 2021]. |
| Intervention type | Behavioural |
| Primary outcome measure | Mother's breastfeeding status (whether they are still exclusively breastfeeding, partially breastfeeding, or not breastfeeding). This is routinely assessed by community health nurse at their infant’s follow-up at first week, second month, fourth month and sixth month of age. |
| Secondary outcome measures | Mother's breastfeeding self-efficacy measured using the Hill & Hummenic questionnaire which will be assessed at first week, second month, fourth month and sixth month of infant’s age during child health clinic visits. |
| Overall study start date | 11/10/2020 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 232 |
| Key inclusion criteria | Primigravida (first-time pregnant mothers) |
| Key exclusion criteria | 1. Has medical conditions requiring to take medications 2. Has attended other breastfeeding interventions in addition to the antenatal breastfeeding workshop they are recruited from |
| Date of first enrolment | 01/07/2022 |
| Date of final enrolment | 30/04/2023 |
Locations
Countries of recruitment
- Brunei Darussalam
Study participating centres
Spg 256 – 23, Kampong Rimba, Gadong
Negara Brunei Darussalam
Bandar Seri Begawan
BE3119
Brunei Darussalam
Bandar Seri Begawan
BB3713
Brunei Darussalam
Sponsor information
Government
Commonwealth Drive
Bandar Seri Begawan
BB3900
Brunei Darussalam
| Phone | +673 (0)238 5800 |
|---|---|
| hpc@moh.gov.bn | |
| Website | http://moh.gov.bn |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (faezah.amin@moh.gov.bn) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/06/2021 | No | Yes |
Additional files
- ISRCTN55245820_PIS.pdf
- Uploaded 01/06/2021
Editorial Notes
11/03/2024: The intention to publish date was changed from 01/02/2024 to 01/01/2025.
11/08/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/06/2021 to 01/07/2022.
2. The recruitment end date was changed from 28/02/2022 to 30/04/2023.
3. The overall end date was changed from 30/07/2022 to 31/12/2023.
4. The intention to publish date was changed from 01/08/2022 to 01/02/2024.
5. The plain English summary was updated to reflect these changes.
01/06/2021: The participant information sheet has been uploaded as an additional file.
10/05/2021: Trial's existence confirmed by Medical and Health Research & Ethics Committee.
