CClinicalTrials.gg
CompletedNCT02081521Updated Mar 11, 2016

Evaluation of a Multiple Behaviour Programme for Diarrhoea Management

An interventional study of Community behaviour change campaign in Diarrhoeal Disease, sponsored by London School of Hygiene and Tropical Medicine. Completed at 1 site in Zambia. Open to participants aged 1 Month to 59 Months. Per ClinicalTrials.gov, last updated 2016-03-11.

Sponsored by London School of Hygiene and Tropical Medicine · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
640
Allocation
Randomized
Ages
1 Month to 59 Months
Sex
All
01

Study 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).

Read the 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.
02

Conditions studied

  • Diarrhoeal Disease

Browse trials for

Keywords

  • behaviour change
  • diarrhoeal disease
  • handwashing
  • breastfeeding
  • diarrhoea management
03

In context

Diarrhea

852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.

This study's enrollment of 640 is above the median of 136 across 713 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

London School of Hygiene and Tropical Medicine is the lead sponsor of 296 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 59 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Not resident in study area
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
640 participants (actual)

Study arms

  • Experimental
    Community behaviour change campaign

    Participants will be exposed to the community behaviour change intervention.

    Behavioral: Community behaviour change campaign

  • 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.

Interventions

  • BehavioralCommunity 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: six weeks post-intervention

  2. Change in target behaviour: correct ORS preparation

    Proportion of caregivers able to demonstrate correct ORS preparation.

    Time frame: six weeks post-intervention

  3. Change in target behaviour: Exclusive breastfeeding

    Proportion of mothers exclusively breastfeeding infants 0-5 months of age.

    Time frame: six weeks post-intervention

  4. 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

    Time frame: six weeks post-intervention

Secondary outcomes

  1. Change in target behaviours: ORS use

    Proportion of under-five diarrhoeal episodes receiving ORS.

    Time frame: six weeks post-intervention

  2. Change in target behaviours: ORS storage

    Proportion of caregivers storing ORS sachets at home

    Time frame: six weeks post-intervention

  3. 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

    Time frame: six weeks post-intervention

  4. Zinc awareness

    Proportion of caregivers who have heard of zinc for diarrhoea treatment

    Time frame: six weeks post-intervention

  5. Change in target behaviours: exclusive breastfeeding 0-2 months

    Proportion of mothers exclusively breastfeeding infants 0-2 months of age.

    Time frame: six weeks post-intervention

  6. Change in target behaviours: predominant breastfeeding

    Proportion of mothers predominantly breastfeeding infants 0-5 months of age.

    Time frame: six weeks post-intervention

  7. 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

    Time frame: six weeks post-intervention

  8. Change in target behaviours: use of soap

    Proportion of observed handwashing occasions where soap is used

    Time frame: six weeks post-intervention

07

Study locations

1 site
  • Centre for Infectious Disease Research Zambia
    Lusaka, Lusaka Province, Zambia
08

References and documents

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. PubMed 29041941 ↗
  • 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. PubMed 27855872 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02081521
Lead sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Centre for Infectious Disease Research in Zambia, Absolute Return for Kids
Responsible party
Sponsor
First posted
Mar 7, 2014
Start date
Jan 2014
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Mar 11, 2016

Study contacts

Roma Chilengi
principal investigator · Centre for Infectious Disease Research in Zambia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion