Plain English Summary
Background and study aims
Drowning is the process of not being able to breathe from being in, or under, a liquid (for example, water). It can result in death, ongoing health problems or a full recovery. Drowning is the 3rd leading cause of death for children aged 1-4 years in many Asian countries. More than 200,000 children drown across Asia every year and 96% of drowning occurs in low and middle income countries. Children under the age of 5 and males are especially at risk of drowning. Risk factors include having access to water, low socio-economic status, lack of education, and lack of parental supervision. In Bangladesh, drowning is the single leading cause of death after infancy. 50% of drowning occurs between ages 0-4 years, 60% of drowning incidents happen during 9am-1pm, 80% drowning cases occur in ponds, ditches, buckets and drums and 80% happen within 20 meters of the house. Children from large families are twice as likely to drown than those from small families. 18225 children drown in Bangladesh every year. Therefore, this study aims to testing the efficacy of a mobile phone app intervention called MOBILE COACH (by sms, images, videos and audios) developed to prevent childhood drowning in Bangladesh.
Who can participate?
Parents with children aged under the age of 5.
What does the study involve?
Participants are randomly allocated to an intervention group or control group depending on in which village they reside. Those in the intervention group are given the mobile coach based intervention. Those in the control group are simply assessed during the study period. The mobile coach app is individually tailored, taking into account demographic data. Individual SMS, audio, videos and images about childhood drowning are sent to the participants of the intervention group over a period of 6 months. Participants receive one text message (SMS) and one image per week and one video and audio text per month. All participants are assessed on their knowledge, safety awareness and behavior practice regarding childhood drowning at the start of the study and 6 months later.
What are the possible benefits and risks of participating?
Participants will benefit from understanding childhood drowning or child injuries in Bangladesh, being given information on the number of cases and risk factors of childhood drowning. They should be able to identify the factors that contribute to drowning and know how to prevent and reduce it. There are no possible risks or side effects. Participation in this study is voluntary.
Where is the study run from?
A community centre in Rajshahi, Bangledesh
When is the study starting and how long is it expected to run for?
March 2015 to September 2015
Who is funding the study?
Ministry of Education, Government of the People's Republic of Bangladesh
Who is the main contact?
Mr Md Hossain
m_population@yahoo.com
Study website
Contact information
Type
Public
Contact name
Mr Md Hossain
ORCID ID
http://orcid.org/0000-0002-1554-3476
Contact details
Serdang
Selangor
43400
Malaysia
0109807282
m_population@yahoo.com
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
FPSK(EXP15)010
Study information
Scientific title
Randomized controlled trial on drowning prevention for parents with children aged below five years in Bangladesh
Acronym
Study hypothesis
Main hypothesis is that the integrated intervention will be more effective and inexpensive way to prevent on childhood drowning among children below aged five years and also increase the parent’s awareness of their children from drowning
Ethics approval(s)
University Putra Malaysia medical research ethics committee, 11/02/2015, ref: UPM / TNCPI / RMC / JKEUPM / 1.4.18.1 / F1
Study design
Two-arm cluster randomised community trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Study setting(s)
Community
Study type
Prevention
Patient information sheet
Condition
Drowning
Intervention
MOBILE COACH based intervention for childhood drowning prevention
Intervention type
Behavioural
Primary outcome measure
Per monthly increase in knowledge, safety awareness and behaviours practice about childhood drowning prevention of the intervention group compared to that of the assessment only control group.
Secondary outcome measures
1. Reducing incidence of childhood drowning
2. Self-efficacy for childhood drowning prevention
3. Determine the risk factors for childhood drowning
Will be measured at baseline and after study end
Overall study start date
01/03/2015
Overall study end date
01/09/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Parents with children under 5
2. Children living with parents
3. Must have access to a mobile phone
Participant type(s)
Patient
Age group
Child
Upper age limit
5 Years
Sex
Both
Target number of participants
1680 parents with children aged under 5
Total final enrolment
788
Participant exclusion criteria
1. Parents who are not available at the time of data collection
2. Children with a physical disability preventing them from walking
Recruitment start date
01/03/2015
Recruitment end date
01/09/2015
Locations
Countries of recruitment
Bangladesh
Study participating centre
Community Centre
Rajshahi
6505
Bangladesh
Sponsor information
Organisation
Government of the People’s Republic of Bangladesh
Sponsor details
Building # 6
Floor # 17th & 18th
Bangladesh Secretariat
Dhaka
6505
Bangladesh
0088029677485
mdsaifullah56@yahoo.com
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Education, Government of the People's Republic of Bangladesh
Alternative name(s)
Ministry of Education, MoE
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Bangladesh
Results and Publications
Publication and dissemination plan
2020 preprint in https://doi.org/10.21203/rs.3.rs-39470/v1 (added 15/10/2020)
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Available on request
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | protocol | 11/05/2015 | Yes | No | |
Other publications | SMS Text Messages for Parents for the Prevention of Child Drowning in Bangladesh: Acceptability Study | 23/09/2020 | 04/04/2023 | Yes | No |