Evaluation of a Multiple Behaviour Programme for Diarrhoea Management
Primary Purpose
Diarrhoeal Disease
Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Community behaviour change campaign
Sponsored by
About this trial
This is an interventional prevention trial for Diarrhoeal Disease focused on measuring behaviour change, diarrhoeal disease, handwashing, breastfeeding, diarrhoea management
Eligibility Criteria
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
Sites / Locations
- Centre for Infectious Disease Research Zambia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Community behaviour change campaign
No community behaviour change campaign
Arm Description
Participants will be exposed to the community behaviour change intervention.
No community intervention will take place in the control arm, although exposure to some intervention messaging (radio adverts) may take place.
Outcomes
Primary Outcome Measures
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.
Change in target behaviour: correct ORS preparation
Proportion of caregivers able to demonstrate correct ORS preparation.
Change in target behaviour: Exclusive breastfeeding
Proportion of mothers exclusively breastfeeding infants 0-5 months of age.
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
Secondary Outcome Measures
Change in target behaviours: ORS use
Proportion of under-five diarrhoeal episodes receiving ORS.
Change in target behaviours: ORS storage
Proportion of caregivers storing ORS sachets at home
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
Zinc awareness
Proportion of caregivers who have heard of zinc for diarrhoea treatment
Change in target behaviours: exclusive breastfeeding 0-2 months
Proportion of mothers exclusively breastfeeding infants 0-2 months of age.
Change in target behaviours: predominant breastfeeding
Proportion of mothers predominantly breastfeeding infants 0-5 months of age.
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
Change in target behaviours: use of soap
Proportion of observed handwashing occasions where soap is used
Full Information
NCT ID
NCT02081521
First Posted
March 5, 2014
Last Updated
March 10, 2016
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Centre for Infectious Disease Research in Zambia, Absolute Return for Kids
1. Study Identification
Unique Protocol Identification Number
NCT02081521
Brief Title
Evaluation of a Multiple Behaviour Programme for Diarrhoea Management
Official Title
Evaluation of a Multiple Behaviour Programme to Prevent and Manage Diarrhoea Among Children Under-five in Lusaka, Zambia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Centre for Infectious Disease Research in Zambia, Absolute Return for Kids
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoeal Disease
Keywords
behaviour change, diarrhoeal disease, handwashing, breastfeeding, diarrhoea management
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
640 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Community behaviour change campaign
Arm Type
Experimental
Arm Description
Participants will be exposed to the community behaviour change intervention.
Arm Title
No community behaviour change campaign
Arm Type
No Intervention
Arm Description
No community intervention will take place in the control arm, although exposure to some intervention messaging (radio adverts) may take place.
Intervention Type
Behavioral
Intervention Name(s)
Community behaviour change campaign
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in target behaviour: zinc use
Description
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.
Time Frame
six weeks post-intervention
Title
Change in target behaviour: correct ORS preparation
Description
Proportion of caregivers able to demonstrate correct ORS preparation.
Time Frame
six weeks post-intervention
Title
Change in target behaviour: Exclusive breastfeeding
Description
Proportion of mothers exclusively breastfeeding infants 0-5 months of age.
Time Frame
six weeks post-intervention
Title
Change in target behaviour: Handwashing with soap
Description
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
Time Frame
six weeks post-intervention
Secondary Outcome Measure Information:
Title
Change in target behaviours: ORS use
Description
Proportion of under-five diarrhoeal episodes receiving ORS.
Time Frame
six weeks post-intervention
Title
Change in target behaviours: ORS storage
Description
Proportion of caregivers storing ORS sachets at home
Time Frame
six weeks post-intervention
Title
Change in target behaviours: zinc trial
Description
Proportion of caregivers of a child under-five who have ever used zinc to treat diarrhoea in a child
Time Frame
six weeks post-intervention
Title
Zinc awareness
Description
Proportion of caregivers who have heard of zinc for diarrhoea treatment
Time Frame
six weeks post-intervention
Title
Change in target behaviours: exclusive breastfeeding 0-2 months
Description
Proportion of mothers exclusively breastfeeding infants 0-2 months of age.
Time Frame
six weeks post-intervention
Title
Change in target behaviours: predominant breastfeeding
Description
Proportion of mothers predominantly breastfeeding infants 0-5 months of age.
Time Frame
six weeks post-intervention
Title
Change in target behaviours: handwashing with soap at key times
Description
Proportion of observed handwashing events associated with food handling or faeces accompanied by handwashing with soap
Time Frame
six weeks post-intervention
Title
Change in target behaviours: use of soap
Description
Proportion of observed handwashing occasions where soap is used
Time Frame
six weeks post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roma Chilengi
Organizational Affiliation
Centre for Infectious Disease Research in Zambia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Infectious Disease Research Zambia
City
Lusaka
State/Province
Lusaka Province
Country
Zambia
12. IPD Sharing Statement
Citations:
PubMed Identifier
29041941
Citation
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.
Results Reference
derived
PubMed Identifier
27855872
Citation
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.
Results Reference
derived
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Evaluation of a Multiple Behaviour Programme for Diarrhoea Management
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