Evaluation of a Multiple Behaviour Programme for Diarrhoea Management

NCT02081521 | Completed

• 1 other identifier: QA511
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

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).

Conditions

Diarrhoeal Disease

Keywords

behaviour change; diarrhoeal disease; handwashing; breastfeeding; diarrhoea management

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Change in target behaviours: ORS use

  six weeks post-intervention

• Change in target behaviours: ORS storage

  six weeks post-intervention

• Change in target behaviours: zinc trial

  six weeks post-intervention

• Zinc awareness

  six weeks post-intervention

• Change in target behaviours: exclusive breastfeeding 0-2 months

  six weeks post-intervention

Study Arms (2)

Community behaviour change campaign

EXPERIMENTAL

Participants will be exposed to the community behaviour change intervention.

Behavioral: Community behaviour change campaign

No community behaviour change campaign

NO INTERVENTION

No community intervention will take place in the control arm, although exposure to some intervention messaging (radio adverts) may take place.

Interventions

Community behaviour change campaign BEHAVIORAL

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.

Community behaviour change campaign

Eligibility Criteria

• Age: 1 Month - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Not resident in study area

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Centre for Infectious Disease Research in Zambia: collaborator
• Absolute Return for Kids: collaborator

Study Sites (1)

Centre for Infectious Disease Research Zambia

Lusaka, Lusaka Province, Zambia

Location

Related Publications (2)

• 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.

  PMID: 29041941 DERIVED

• 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.

  PMID: 27855872 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Roma Chilengi

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 7, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 11, 2016

Record last verified: 2016-03

Locations

ZA (1)