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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081521
• Other study ID #: QA511
• Status: Completed
• Phase: N/A
• First received: March 5, 2014
• Last updated: March 10, 2016
• Start date: January 2014
• Est. completion date: November 2014

Study information

• Verified date: March 2016
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zambia: Ministry of Health
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 59 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diarrhea
• Diarrhoeal Disease

Intervention

Behavioral:
• Community behaviour change campaign
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.

Locations

Country	Name	City	State
Zambia	Centre for Infectious Disease Research Zambia	Lusaka	Lusaka Province

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Absolute Return for Kids, Centre for Infectious Disease Research in Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Change in target behaviour: correct ORS preparation	Proportion of caregivers able to demonstrate correct ORS preparation.	six weeks post-intervention	No
Primary	Change in target behaviour: Exclusive breastfeeding	Proportion of mothers exclusively breastfeeding infants 0-5 months of age.	six weeks post-intervention	No
Primary	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	No
Secondary	Change in target behaviours: ORS use	Proportion of under-five diarrhoeal episodes receiving ORS.	six weeks post-intervention	No
Secondary	Change in target behaviours: ORS storage	Proportion of caregivers storing ORS sachets at home	six weeks post-intervention	No
Secondary	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	No
Secondary	Zinc awareness	Proportion of caregivers who have heard of zinc for diarrhoea treatment	six weeks post-intervention	No
Secondary	Change in target behaviours: exclusive breastfeeding 0-2 months	Proportion of mothers exclusively breastfeeding infants 0-2 months of age.	six weeks post-intervention	No
Secondary	Change in target behaviours: predominant breastfeeding	Proportion of mothers predominantly breastfeeding infants 0-5 months of age.	six weeks post-intervention	No
Secondary	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	No
Secondary	Change in target behaviours: use of soap	Proportion of observed handwashing occasions where soap is used	six weeks post-intervention	No

External Links

•   Background information on the PAED programme within which the community behaviour change programme sits