Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/02/2015
Date assigned
08/03/2015
Last edited
11/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Public

Primary contact

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 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

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

Trial setting

Community

Trial type

Prevention

Patient information sheet

Condition

Drowning

Intervention

MOBILE COACH based intervention for childhood drowning prevention

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/2015

Overall trial end date

01/09/2015

Reason abandoned

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

Patient

Age group

Child

Gender

Both

Target number of participants

1680 parents with children aged under 5

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

Trial 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

Federal/National Government

Location

Bangladesh

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25957574

Publication citations

Additional files

Editorial Notes