Clinical trial NCT01146496: A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia
Official title: A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pesticide Poisoning
Keywords: Pesticide poisoning
Suicide
Unintentional poisoning
Prevention
Cluster randomised controlled trial
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: University of Bristol
name: University of Oxford
name: University of Peradeniya
name: University of Kelaniya
name: University of Copenhagen
First posted: 2010-06-17
Enrollment: 223861
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A major global public health priority is to identify effective methods for preventing deaths from pesticide self-poisoning. The aim of this work is to determine whether the provision of lockable storage containers to poor households in rural Asia can reduce the incidence of intentional pesticide self-poisoning. Secondary questions include the effect of these containers on unintentional pesticide poisoning in children and overall self-harm.

Detailed description: We will set up a large community-based, cluster randomised controlled trial of 162 villages (mean adult population 900) in rural Sri Lanka to determine the effectiveness and cost of the provision of safe storage containers to prevent pesticide poisoning.

The study will be based in Anuradhapura District where we have carried out public health studies of pesticide poisoning since 2002. 81 intervention and 81 control villages will be recruited. Randomisation will be clustered, with villages rather than households randomised. A census will be performed at baseline and after 3 years to establish the population demographics and number of person-years exposed.

The primary outcome will be the incidence of pesticide self-poisoning; secondary outcomes will be the incidence of all self-poisoning, all self-harm, fatal self-harm, pesticide poisoning and unintentional paediatric pesticide poisoning. We will use Poisson regression models, taking account of clustering and stratification, for the analysis.

The study will provide definitive evidence concerning the cost-effectiveness of this approach that will determine whether it should be promoted across Asia.

Eligibility criteria: Inclusion Criteria:

* Any village in the study area that gives consent to the study

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of Pesticide Self-poisoning
timeFrame: For three years after intervention
Secondary outcomes:
measure: Incidence of All Self-poisoning
timeFrame: For three years post-intervention
measure: Incidence of All Self-harm
timeFrame: For three years after intervention
measure: Incidence of Fatal Self-harm
timeFrame: For three years post intervention
measure: Incidence of Pesticide Poisoning
timeFrame: For three years post intervention
measure: Incidence of Unintentional Paediatric Pesticide Poisoning
timeFrame: For three years post intervention
Other outcomes:
Locations:
city: Anuradhapura
country: Sri Lanka
facility: Mahaweli H area
state: North Central Province
Study officials:
affiliation: University of Edinburgh
name: Michael Eddleston
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Flemming Konradsen
role: STUDY_DIRECTOR
References:
citation: Pearson M, Metcalfe C, Jayamanne S, Gunnell D, Weerasinghe M, Pieris R, Priyadarshana C, Knipe DW, Hawton K, Dawson AH, Bandara P, deSilva D, Gawarammana I, Eddleston M, Konradsen F. Effectiveness of household lockable pesticide storage to reduce pesticide self-poisoning in rural Asia: a community-based, cluster-randomised controlled trial. Lancet. 2017 Oct 21;390(10105):1863-1872. doi: 10.1016/S0140-6736(17)31961-X. Epub 2017 Aug 11.
citation: Knipe DW, Gunnell D, Pieris R, Priyadarshana C, Weerasinghe M, Pearson M, Jayamanne S, Dawson AH, Mohamed F, Gawarammana I, Hawton K, Konradsen F, Eddleston M, Metcalfe C. Is socioeconomic position associated with risk of attempted suicide in rural Sri Lanka? A cross-sectional study of 165 000 individuals. BMJ Open. 2017 Mar 22;7(3):e014006. doi: 10.1136/bmjopen-2016-014006.
citation: Madsen LB, Eddleston M, Hansen KS, Pearson M, Agampodi S, Jayamanne S, Konradsen F. Cost-effectiveness analyses of self-harm strategies aimed at reducing the mortality of pesticide self-poisonings in Sri Lanka: a study protocol. BMJ Open. 2015 Feb 27;5(2):e007333. doi: 10.1136/bmjopen-2014-007333.
citation: Pearson M, Konradsen F, Gunnell D, Dawson AH, Pieris R, Weerasinghe M, Knipe DW, Jayamanne S, Metcalfe C, Hawton K, Wickramasinghe AR, Atapattu W, Bandara P, de Silva D, Ranasinghe A, Mohamed F, Buckley NA, Gawarammana I, Eddleston M. A community-based cluster randomised trial of safe storage to reduce pesticide self-poisoning in rural Sri Lanka: study protocol. BMC Public Health. 2011 Nov 21;11:879. doi: 10.1186/1471-2458-11-879.