Diarrhoeal DiseaseNCT02081521
Evaluation of a Multiple Behaviour Programme for Diarrhoea Management
A study testing Community behaviour change campaign in people with Diarrhoeal Disease, run by London School of Hygiene and Tropical Medicine at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 59 months
- Conditions the study is for
- Diarrhoeal Disease
- What is being tested?
- Community behaviour change campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteZambia
- Study dates
- Jan 2014to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Not resident in study area
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Centre for Infectious Disease Research Zambia
Lusaka, Lusaka Province
About this study
Official title: 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).
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
- 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.
- Conditions
- Diarrhoeal Disease
- Being tested
- Community behaviour change campaign
- Keywords
- behaviour change, diarrhoeal disease, handwashing, breastfeeding, diarrhoea management
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community behaviour change campaignBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Community behaviour change campaign | Experimental | Participants will be exposed to the community behaviour change intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six weeks post-intervention
Change in target behaviour: correct ORS preparation
Proportion of caregivers able to demonstrate correct ORS preparation.
Measured: six weeks post-intervention
Change in target behaviour: Exclusive breastfeeding
Proportion of mothers exclusively breastfeeding infants 0-5 months of age.
Measured: 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
Measured: six weeks post-intervention
Secondary outcomes (8)
Change in target behaviours: ORS use
Proportion of under-five diarrhoeal episodes receiving ORS.
Measured: six weeks post-intervention
Change in target behaviours: ORS storage
Proportion of caregivers storing ORS sachets at home
Measured: 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
Measured: six weeks post-intervention
Zinc awareness
Proportion of caregivers who have heard of zinc for diarrhoea treatment
Measured: six weeks post-intervention
Change in target behaviours: exclusive breastfeeding 0-2 months
Proportion of mothers exclusively breastfeeding infants 0-2 months of age.
Measured: six weeks post-intervention
Change in target behaviours: predominant breastfeeding
Proportion of mothers predominantly breastfeeding infants 0-5 months of age.
Measured: 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
Measured: six weeks post-intervention
Change in target behaviours: use of soap
Proportion of observed handwashing occasions where soap is used
Measured: six weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diarrhoeal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, Absolute Return for Kids
- Responsible party
- Sponsor
- Investigators
- Roma Chilengi, Principal investigator, Centre for Infectious Disease Research in Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081521
- Sponsor's protocol ID
- QA511
- Status last verified
- Mar 2016
- First submitted
- 5 Mar 2014
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
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 29041941Greenland 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multiple Behaviour Programme to Prevent and Manage Diarrhoea Among Children Under-five in Lusaka, Zambia
- ClinicalTrials.gov ID
- NCT02081521
- Acronym / sponsor ID
- QA511
- Conditions
- Diarrhoeal Disease
- Keywords
- behaviour change, diarrhoeal disease, handwashing, breastfeeding, diarrhoea management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, Absolute Return for Kids
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community behaviour change campaign | Experimental | Behavioral: Community behaviour change campaignParticipants will be exposed to the community behaviour change intervention. |
| 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. |
Who may qualify
- Ages
- 1 month to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Not resident in study area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community behaviour change campaignCommunity 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. | Behavioural | Community behaviour change campaign |
Primary outcome
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.
Change in target behaviour: correct ORS preparation
Time frame: six weeks post-intervention
Proportion of caregivers able to demonstrate correct ORS preparation.
Change in target behaviour: Exclusive breastfeeding
Time frame: six weeks post-intervention
Proportion of mothers exclusively breastfeeding infants 0-5 months of age.
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
8 secondary outcomes
Change in target behaviours: ORS use
Time frame: six weeks post-intervention
Change in target behaviours: ORS storage
Time frame: six weeks post-intervention
Change in target behaviours: zinc trial
Time frame: six weeks post-intervention
Zinc awareness
Time frame: six weeks post-intervention
Change in target behaviours: exclusive breastfeeding 0-2 months
Time frame: six weeks post-intervention
Change in target behaviours: predominant breastfeeding
Time frame: six weeks post-intervention
Change in target behaviours: handwashing with soap at key times
Time frame: six weeks post-intervention
Change in target behaviours: use of soap
Time frame: six weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Derived from this study: PubMed 29041941Greenland 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.
- Derived from this study: PubMed 27855872Greenland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roma Chilengi principal investigator
Centre for Infectious Disease Research in Zambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community behaviour change campaign in people with Diarrhoeal Disease, run by London School of Hygiene and Tropical Medicine at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in target behaviour: zinc use (time frame: six weeks post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02081521, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016; AzTrials last refreshed its copy on 29 Oct 2026.