Clinical trial NCT02081521: Evaluation of a Multiple Behaviour Programme for Diarrhoea Management
Official title: Evaluation of a Multiple Behaviour Programme to Prevent and Manage Diarrhoea Among Children Under-five in Lusaka, Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhoeal Disease
Keywords: behaviour change
diarrhoeal disease
handwashing
breastfeeding
diarrhoea management
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Centre for Infectious Disease Research in Zambia
name: Absolute Return for Kids
First posted: 2014-03-07
Enrollment: 640
Sex: ALL
Minimum age (years): 1
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Control of diarrhoeal disease requires a comprehensive package of preventive and curative interventions. in Zambia, the Programme for Awareness and Elimination of Diarrhoea (PAED) aims to reduce child deaths by combating diarrhoea in Lusaka province, Zambia. The behaviour change component of the PAED programme seeks to change behaviours important for diarrhoea prevention (handwashing with soap and exclusive breastfeeding) and improved treatment outcomes (use of oral rehydration solution (ORS) and zinc in home management of child diarrhoea).

The study aims to evaluate the feasibility of implementing a multiple behaviour change community programme to tackle diarrhoeal disease in children under-five and to assess the impact of this programme on practice of the target behaviours by caregivers of children under-five. The research questions will be answered through a a two-arm cluster-randomised trial (eight clusters per study arm).

Detailed description: Specific objectives of the study are as follows:

* Evaluate the effect of the programme on ORS and zinc uptake and usage, exclusive breastfeeding and handwashing with soap (primary objective)
* Determine the extent to which the programme has positively influenced key mediating factors that determine behaviour (i.e. social norms, physical infrastructure, attitudes, and disease and treatment perceptions)
* Investigate which components of the community programme (i.e. specific activities in clinics, community events etc.) are linked to the success of the programme (most acceptable, feasible etc) and in what context

  o Validate model of intervention theory that explains how the context and mechanisms of the intervention interact to produce behavioural outcomes
* Determine which target populations are more likely to uptake the desired behaviours and identify the supporting factors that might explain this
* Conduct process evaluation to assess i) if the programme has been implemented as intended, ii) if the desired levels of reach and coverage have been achieved, iii) costs of implementation, iv) the extent to which changes in behaviour are likely to be due to the intervention.

Eligibility criteria: Inclusion Criteria:

* caregiver with child under six months (for assessment of handwashing and exclusive breastfeeding outcomes - healthy volunteers)
* caregiver with child under five years with current or recent (last 7 days) diarrhoea (for assessment of ORS and zinc outcomes)

Exclusion Criteria:

* Not resident in study area

Primary outcomes:
measure: Change in target behaviour: zinc use
timeFrame: six weeks post-intervention
measure: Change in target behaviour: correct ORS preparation
timeFrame: six weeks post-intervention
measure: Change in target behaviour: Exclusive breastfeeding
timeFrame: six weeks post-intervention
measure: Change in target behaviour: Handwashing with soap
timeFrame: six weeks post-intervention
Secondary outcomes:
measure: Change in target behaviours: ORS use
timeFrame: six weeks post-intervention
measure: Change in target behaviours: ORS storage
timeFrame: six weeks post-intervention
measure: Change in target behaviours: zinc trial
timeFrame: six weeks post-intervention
measure: Zinc awareness
timeFrame: six weeks post-intervention
measure: Change in target behaviours: exclusive breastfeeding 0-2 months
timeFrame: six weeks post-intervention
measure: Change in target behaviours: predominant breastfeeding
timeFrame: six weeks post-intervention
measure: Change in target behaviours: handwashing with soap at key times
timeFrame: six weeks post-intervention
measure: Change in target behaviours: use of soap
timeFrame: six weeks post-intervention
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Centre for Infectious Disease Research Zambia
state: Lusaka Province
Study officials:
affiliation: Centre for Infectious Disease Research in Zambia
name: Roma Chilengi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greenland K, Chipungu J, Chilekwa J, Chilengi R, Curtis V. Disentangling the effects of a multiple behaviour change intervention for diarrhoea control in Zambia: a theory-based process evaluation. Global Health. 2017 Oct 17;13(1):78. doi: 10.1186/s12992-017-0302-0.
citation: Greenland K, Chipungu J, Curtis V, Schmidt WP, Siwale Z, Mudenda M, Chilekwa J, Lewis JJ, Chilengi R. Multiple behaviour change intervention for diarrhoea control in Lusaka, Zambia: a cluster randomised trial. Lancet Glob Health. 2016 Dec;4(12):e966-e977. doi: 10.1016/S2214-109X(16)30262-5.