Evaluation of a Multiple Behaviour Programme for Diarrhoea Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a Multiple Behaviour Programme to Prevent and Manage Diarrhoea Among Children Under-five in Lusaka, Zambia

Conditions
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Diarrhoeal Disease

Intervention / Treatment
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* Behavioral: Community behaviour change campaign


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community behaviour change campaign<br>Participants will be exposed to the community behaviour change intervention. | Behavioral: Community behaviour change campaign<br>* Community campaign targeting exclusive breastfeeding, handwashing with soap, and use of ORS and zinc to manage child diarrhoea. Includes a range of activities within the community (large events and small group sessions); clinic activities (ORS preparation), radio adverts.<br>|
| No Intervention: No community behaviour change campaign<br>No community intervention will take place in the control arm, although exposure to some intervention messaging (radio adverts) may take place. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in target behaviour: zinc use | Proportion of under-five diarrhoeal episodes receiving zinc. The study aims to demonstrate the intervention can successfully change behaviour and therefore no health outcomes were chosen and there is a primary outcome for each behaviour. | six weeks post-intervention | 
| Change in target behaviour: correct ORS preparation | Proportion of caregivers able to demonstrate correct ORS preparation. | six weeks post-intervention | 
| Change in target behaviour: Exclusive breastfeeding | Proportion of mothers exclusively breastfeeding infants 0-5 months of age. | six weeks post-intervention | 
| Change in target behaviour: Handwashing with soap | Proportion of observed handwashing events where there is risk of faecal contamination (i.e. after latrine and when dealing with child stools) accompanied by handwashing with soap | six weeks post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in target behaviours: ORS use | Proportion of under-five diarrhoeal episodes receiving ORS. | six weeks post-intervention | 
| Change in target behaviours: ORS storage | Proportion of caregivers storing ORS sachets at home | six weeks post-intervention | 
| Change in target behaviours: zinc trial | Proportion of caregivers of a child under-five who have ever used zinc to treat diarrhoea in a child | six weeks post-intervention | 
| Zinc awareness | Proportion of caregivers who have heard of zinc for diarrhoea treatment | six weeks post-intervention | 
| Change in target behaviours: exclusive breastfeeding 0-2 months | Proportion of mothers exclusively breastfeeding infants 0-2 months of age. | six weeks post-intervention | 
| Change in target behaviours: predominant breastfeeding | Proportion of mothers predominantly breastfeeding infants 0-5 months of age. | six weeks post-intervention | 
| Change in target behaviours: handwashing with soap at key times | Proportion of observed handwashing events associated with food handling or faeces accompanied by handwashing with soap | six weeks post-intervention | 
| Change in target behaviours: use of soap | Proportion of observed handwashing occasions where soap is used | six weeks post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behaviour change, diarrhoeal disease, handwashing, breastfeeding, diarrhoea management