Evaluation of a Multiple Behaviour Programme to Prevent and Manage Diarrhoea Among Children Under-five in Lusaka, Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Change in target behaviour: Exclusive breastfeeding
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Not resident in study area
研究组 & 干预措施
Community behaviour change campaign
Participants will be exposed to the community behaviour change intervention.
干预措施: Community behaviour change campaign (Behavioral)
No community behaviour change campaign
No community intervention will take place in the control arm, although exposure to some intervention messaging (radio adverts) may take place.
结局指标
主要结局
Change in target behaviour: Exclusive breastfeeding
时间窗: six weeks post-intervention
Proportion of mothers exclusively breastfeeding infants 0-5 months of age.
Change in target behaviour: correct ORS preparation
时间窗: six weeks post-intervention
Proportion of caregivers able to demonstrate correct ORS preparation.
Change in target behaviour: Handwashing with soap
时间窗: six weeks post-intervention
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
Change in target behaviour: zinc use
时间窗: six weeks post-intervention
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.
次要结局
- Change in target behaviours: exclusive breastfeeding 0-2 months(six weeks post-intervention)
- Change in target behaviours: predominant breastfeeding(six weeks post-intervention)
- Change in target behaviours: ORS use(six weeks post-intervention)
- Change in target behaviours: ORS storage(six weeks post-intervention)
- Zinc awareness(six weeks post-intervention)
- Change in target behaviours: handwashing with soap at key times(six weeks post-intervention)
- Change in target behaviours: zinc trial(six weeks post-intervention)
- Change in target behaviours: use of soap(six weeks post-intervention)