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Register:	ClinicalTrials.gov
Last refreshed on:	11 April 2016
Main ID:	NCT02081521
Date of registration:	05/03/2014
Prospective Registration:	No
Primary sponsor:	London School of Hygiene and Tropical Medicine
Public title:	Evaluation of a Multiple Behaviour Programme for Diarrhoea Management
Scientific title:	Evaluation of a Multiple Behaviour Programme to Prevent and Manage Diarrhoea Among Children Under-five in Lusaka, Zambia
Date of first enrolment:	January 2014
Target sample size:	640
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02081521
Study type:	Interventional
Study design:	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Phase:	N/A

Countries of recruitment
Zambia

Contacts

Name:	Roma Chilengi
Address:
Telephone:
Email:
Affiliation:	Centre for Infectious Disease Research in Zambia

Key inclusion & exclusion 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

Age minimum: 1 Month
Age maximum: 59 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Diarrhoeal Disease

Intervention(s)

Behavioral: Community behaviour change campaign

Primary Outcome(s)

Change in target behaviour: zinc use [Time Frame: six weeks post-intervention]

Change in target behaviour: Exclusive breastfeeding [Time Frame: six weeks post-intervention]

Change in target behaviour: Handwashing with soap [Time Frame: six weeks post-intervention]

Change in target behaviour: correct ORS preparation [Time Frame: six weeks post-intervention]

Secondary Outcome(s)

Change in target behaviours: exclusive breastfeeding 0-2 months [Time Frame: six weeks post-intervention]

Change in target behaviours: ORS use [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]

Zinc awareness [Time Frame: six weeks post-intervention]

Change in target behaviours: use of soap [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]

Secondary ID(s)

QA511

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Absolute Return for Kids

Centre for Infectious Disease Research in Zambia

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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