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Evaluation of a Multiple Behaviour Programme for Diarrhoea Management

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ClinicalTrials.gov Identifier: NCT02081521
Recruitment Status : Completed
First Posted : March 7, 2014
Last Update Posted : March 11, 2016
Sponsor:
Collaborators:
Centre for Infectious Disease Research in Zambia
Absolute Return for Kids
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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).


Condition or disease Intervention/treatment Phase
Diarrhoeal Disease Behavioral: Community behaviour change campaign Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of a Multiple Behaviour Programme to Prevent and Manage Diarrhoea Among Children Under-five in Lusaka, Zambia
Study Start Date : January 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Community behaviour change campaign
Participants will be exposed to the community behaviour change 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.

No Intervention: 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.



Primary Outcome Measures :
  1. Change in target behaviour: zinc use [ Time Frame: 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.


  2. Change in target behaviour: correct ORS preparation [ Time Frame: six weeks post-intervention ]
    Proportion of caregivers able to demonstrate correct ORS preparation.

  3. Change in target behaviour: Exclusive breastfeeding [ Time Frame: six weeks post-intervention ]
    Proportion of mothers exclusively breastfeeding infants 0-5 months of age.

  4. Change in target behaviour: Handwashing with soap [ Time Frame: 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


Secondary Outcome Measures :
  1. Change in target behaviours: ORS use [ Time Frame: six weeks post-intervention ]
    Proportion of under-five diarrhoeal episodes receiving ORS.

  2. Change in target behaviours: ORS storage [ Time Frame: six weeks post-intervention ]
    Proportion of caregivers storing ORS sachets at home

  3. Change in target behaviours: zinc trial [ Time Frame: six weeks post-intervention ]
    Proportion of caregivers of a child under-five who have ever used zinc to treat diarrhoea in a child

  4. Zinc awareness [ Time Frame: six weeks post-intervention ]
    Proportion of caregivers who have heard of zinc for diarrhoea treatment

  5. Change in target behaviours: exclusive breastfeeding 0-2 months [ Time Frame: six weeks post-intervention ]
    Proportion of mothers exclusively breastfeeding infants 0-2 months of age.

  6. Change in target behaviours: predominant breastfeeding [ Time Frame: six weeks post-intervention ]
    Proportion of mothers predominantly breastfeeding infants 0-5 months of age.

  7. Change in target behaviours: handwashing with soap at key times [ Time Frame: six weeks post-intervention ]
    Proportion of observed handwashing events associated with food handling or faeces accompanied by handwashing with soap

  8. Change in target behaviours: use of soap [ Time Frame: six weeks post-intervention ]
    Proportion of observed handwashing occasions where soap is used



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081521


Locations
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Zambia
Centre for Infectious Disease Research Zambia
Lusaka, Lusaka Province, Zambia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Centre for Infectious Disease Research in Zambia
Absolute Return for Kids
Investigators
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Principal Investigator: Roma Chilengi Centre for Infectious Disease Research in Zambia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02081521    
Other Study ID Numbers: QA511
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: March 2016
Keywords provided by London School of Hygiene and Tropical Medicine:
behaviour change
diarrhoeal disease
handwashing
breastfeeding
diarrhoea management
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive