Evaluation of a Multiple Behaviour Programme for Diarrhoea Management
10 de marzo de 2016 actualizado por: London School of Hygiene and Tropical Medicine
Evaluation of a Multiple Behaviour Programme to Prevent and Manage Diarrhoea Among Children Under-five in Lusaka, Zambia
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).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
640
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Lusaka Province
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Lusaka, Lusaka Province, Zambia
- Centre for Infectious Disease Research Zambia
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
1 mes a 4 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Community behaviour change campaign
Participants will be exposed to the community behaviour change intervention.
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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.
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Sin intervención: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in target behaviour: zinc use
Periodo de tiempo: 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. |
six weeks post-intervention
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Change in target behaviour: correct ORS preparation
Periodo de tiempo: six weeks post-intervention
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Proportion of caregivers able to demonstrate correct ORS preparation.
|
six weeks post-intervention
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Change in target behaviour: Exclusive breastfeeding
Periodo de tiempo: six weeks post-intervention
|
Proportion of mothers exclusively breastfeeding infants 0-5 months of age.
|
six weeks post-intervention
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Change in target behaviour: Handwashing with soap
Periodo de tiempo: 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
|
six weeks post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in target behaviours: ORS use
Periodo de tiempo: six weeks post-intervention
|
Proportion of under-five diarrhoeal episodes receiving ORS.
|
six weeks post-intervention
|
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Change in target behaviours: ORS storage
Periodo de tiempo: six weeks post-intervention
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Proportion of caregivers storing ORS sachets at home
|
six weeks post-intervention
|
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Change in target behaviours: zinc trial
Periodo de tiempo: six weeks post-intervention
|
Proportion of caregivers of a child under-five who have ever used zinc to treat diarrhoea in a child
|
six weeks post-intervention
|
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Zinc awareness
Periodo de tiempo: six weeks post-intervention
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Proportion of caregivers who have heard of zinc for diarrhoea treatment
|
six weeks post-intervention
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Change in target behaviours: exclusive breastfeeding 0-2 months
Periodo de tiempo: six weeks post-intervention
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Proportion of mothers exclusively breastfeeding infants 0-2 months of age.
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six weeks post-intervention
|
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Change in target behaviours: predominant breastfeeding
Periodo de tiempo: six weeks post-intervention
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Proportion of mothers predominantly breastfeeding infants 0-5 months of age.
|
six weeks post-intervention
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Change in target behaviours: handwashing with soap at key times
Periodo de tiempo: six weeks post-intervention
|
Proportion of observed handwashing events associated with food handling or faeces accompanied by handwashing with soap
|
six weeks post-intervention
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Change in target behaviours: use of soap
Periodo de tiempo: six weeks post-intervention
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Proportion of observed handwashing occasions where soap is used
|
six weeks post-intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Roma Chilengi, Centre for Infectious Disease Research in Zambia
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2014
Finalización primaria (Actual)
1 de noviembre de 2014
Finalización del estudio (Actual)
1 de noviembre de 2014
Fechas de registro del estudio
Enviado por primera vez
5 de marzo de 2014
Primero enviado que cumplió con los criterios de control de calidad
5 de marzo de 2014
Publicado por primera vez (Estimar)
7 de marzo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
11 de marzo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
10 de marzo de 2016
Última verificación
1 de marzo de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- QA511
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