Caricature-based Antenatal BreastFeeding Education Trial (CABFET)
| ISRCTN | ISRCTN60994059 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60994059 |
- Submission date
- 15/07/2022
- Registration date
- 19/07/2022
- Last edited
- 28/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Antenatal breastfeeding education is essential in supporting future mothers to breastfeed their newborns. Nowadays, health care professionals are innovating teaching methods and using technology in patient education to gain patient satisfaction and change their behaviors. Therefore, this clinical trial aims to examine the effect of caricature-based breastfeeding education in increasing exclusive breastfeeding practice and reducing the unnecessary use of milk formula.
Who can participate?
Pregnant women in the second or third trimester who attend follow-up in primary care centers belonging to Riyadh First Health Cluster (C1) in Saudi Arabia.
What does the study involve?
Participants will be allocated to one of two groups, with an equal chance of being in either group (like tossing a coin). One group will receive caricature-based online lectures on breastfeeding for 2 hours, while the other group will receive a 1-hour standard online lecture on breastfeeding. All participants will be provided a paper booklet on breastfeeding. Participants will be followed up until 3 months after delivery using electronic Google surveys delivered via WhatsApp.
What are the possible benefits and risks of participating?
The pregnant women who join the study as participants will benefit from the educational sessions. There is no expected harm to them and their data will be kept confidential.
Where is the study run from?
Ministry of Health (Saudi Arabia)
When is the study starting and how long is it expected to run for?
September 2020 to December 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Dr Fouzia Alhreashy; fouziaalhreashy@yahoo.com
2. Arwa Mobeirek; Arwa.Mobeirek@gmail.com
Contact information
Scientific
Ministry of Health
Riyadh
13216
Saudi Arabia
| Arwa.Mobeirek@gmail.com |
Scientific
Ministry of Health
Riyadh
13216
Saudi Arabia
 ORCID ID |
0000-0003-3329-7640 |
|---|---|
| falhreashy@moh.gov.sa |
Study information
| Study design | Single-center interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Caricature-based antenatal breastfeeding education: a randomized controlled trial |
| Study acronym | CABFET |
| Study objectives | Caricature-based antenatal breastfeeding education will increase exclusive breastfeeding rate at one month and 3 months postpartum by 17%. |
| Ethics approval(s) | Approved 25/03/2021, King Saud Medical City Institutional Review Board Committee (Imam Abdul Aziz Ibn Muhammad Ibn Saud, Ulaishah, Riyadh; +966 435 5555 ext. 2345; irb@ksmc.med.sa), ref: H1RI-10-Mar21-01 |
| Health condition(s) or problem(s) studied | Antenatal breastfeeding education |
| Intervention | Previous: Random allocation to intervention or control groups was done via randomizer.org. Updated 02/08/2022: Participants were randomly assigned to the intervention or control arms in a 1:1 ratio using computerized random numbers. The intervention group received two caricature-based lectures on breastfeeding (2 hours). The control group received one standard lecture on breastfeeding (1 hour). Both groups received a breastfeeding paper booklet. There will be 4 follow-up points of data collection. First follow-up (during pregnancy before the intervention): sociodemographic data and intention to breastfeed Second follow-up (during pregnancy after the intervention): prenatal breastfeeding self-efficacy scale and satisfaction about health education Third follow-up (1 month postpartum): infant feeding practice and breastfeeding self-efficacy scale – short form Fourth follow-up (3 months postpartum): infant feeding practice and Iowa infant feeding attitude scale |
| Intervention type | Behavioural |
| Primary outcome measure | Exclusive breastfeeding measured using electronic Google surveys on infant feeding practice delivered via WhatsApp at 1 and 3 months postpartum |
| Secondary outcome measures | 1. Prenatal breastfeeding self-efficacy measured using the prenatal breastfeeding self-efficacy scale during pregnancy after the intervention 2. Maternal satisfaction about the health education measured using the satisfaction about health education questionnaire during pregnancy after the intervention 3. Postpartum breastfeeding self-efficacy measured using the breastfeeding self-efficacy scale – short form at 1 month postpartum 4. Infant feeding attitude measured using the Iowa infant feeding attitude scale at 3 months postpartum |
| Overall study start date | 01/09/2020 |
| Completion date | 01/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 270 |
| Total final enrolment | 85 |
| Key inclusion criteria | 1. Aged >18 years 2. Pregnant women in the second or third trimesters 3. Receiving antenatal care in Riyadh First Health Cluster (C1) 4. No contraindication to breastfeeding 5. Have access to the internet 6. Literate |
| Key exclusion criteria | 1. Pregnant women in the first trimester 2. Contraindication to breastfeeding 3. No access to internet 4. Illiterate |
| Date of first enrolment | 01/05/2021 |
| Date of final enrolment | 01/05/2022 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
North Wing
Gate D
Al Akaria Plaza
Riyadh
11622
Saudi Arabia
Sponsor information
Government
Digital City
Prince Turki Bin Abdulaziz Al Awwal Road
Al Nakheel
Riyadh
12382
Saudi Arabia
| Phone | +966112059911 |
|---|---|
| nutrition@moh.gov.sa | |
| Website | https://www.moh.gov.sa/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | Data sharing statement to be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/04/2024 | 28/05/2024 | Yes | No |
Editorial Notes
28/05/2024: Publication reference added.
02/08/2022: The interventions were updated.
01/08/2022: Both of the scientific contacts' details have been updated.
19/07/2022: Trial’s existence confirmed by King Saud Medical City Institutional Review Board Committee.
