Evaluation of a Multiple Behaviour Programme for Diarrhoea Management

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).

Study Overview

• Status: Completed
• Conditions: Diarrhoeal Disease
• Intervention / Treatment: Behavioral: Community behaviour change campaign

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.

• Study Type: Interventional
• Enrollment (Actual): 640
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Lusaka Province
    • Lusaka, Lusaka Province, Zambia
      • Centre for Infectious Disease Research Zambia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in target behaviour: correct ORS preparation	Proportion of caregivers able to demonstrate correct ORS preparation.	six weeks post-intervention
Change in target behaviour: Exclusive breastfeeding	Proportion of mothers exclusively breastfeeding infants 0-5 months of age.	six weeks post-intervention
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in target behaviours: ORS use	Proportion of under-five diarrhoeal episodes receiving ORS.	six weeks post-intervention
Change in target behaviours: ORS storage	Proportion of caregivers storing ORS sachets at home	six weeks post-intervention
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
Zinc awareness	Proportion of caregivers who have heard of zinc for diarrhoea treatment	six weeks post-intervention
Change in target behaviours: exclusive breastfeeding 0-2 months	Proportion of mothers exclusively breastfeeding infants 0-2 months of age.	six weeks post-intervention
Change in target behaviours: predominant breastfeeding	Proportion of mothers predominantly breastfeeding infants 0-5 months of age.	six weeks post-intervention
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
Change in target behaviours: use of soap	Proportion of observed handwashing occasions where soap is used	six weeks post-intervention

Collaborators and Investigators

• Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Centre for Infectious Disease Research in Zambia; Absolute Return for Kids
• Investigators: Principal Investigator: Roma Chilengi, Centre for Infectious Disease Research in Zambia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (Estimate): March 7, 2014

Study Record Updates

• Last Update Posted (Estimate): March 11, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: breastfeeding; handwashing; behaviour change; diarrhoeal disease; diarrhoea management
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: QA511