Evaluation of a Multiple Behaviour Programme for Diarrhoea Management

Diarrhoeal Disease Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Diarrhoeal Disease

• NCT number: NCT02081521
• Study type: Interventional
• Source: London School of Hygiene and Tropical Medicine
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Completion date: November 2014