Community Based Intervention and Evaluation of the Impact of Social Marketing of a Diarrhea Management Pack
Primary Purpose
Diarrhea
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Diarrhea Pack
ORS
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring Children, Recovery, Diarrhea Pack, Social Marketing
Eligibility Criteria
Inclusion Criteria:
- Children under 5 years of age suffering from diarrhea residing in study area and having consent to participate
Exclusion Criteria:
- Failure to provide consent or children having debilitating illness or requiring emergency hospital care.
Sites / Locations
- AKU Project Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm Description
A diarrhea Pack comprising of low osmolality ORS, Zinc, water purification sachets and pictorial chart.
Standard Care through National LHW (Lady Health Workers)program
Outcomes
Primary Outcome Measures
Reduction in Diarrhea related morbidity
Secondary Outcome Measures
Full Information
NCT ID
NCT00942812
First Posted
July 20, 2009
Last Updated
August 9, 2011
Sponsor
Aga Khan University
Collaborators
John Snow, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00942812
Brief Title
Community Based Intervention and Evaluation of the Impact of Social Marketing of a Diarrhea Management Pack
Official Title
A Community Based Intervention and Evaluation of the Impact of Social Marketing of a Diarrhea Management Pack(Comprising of Low Osmolality ORS, Zinc Tablets, Water Purification Tablets and Pictorial Chart) on Childhood Diarrhea.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aga Khan University
Collaborators
John Snow, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Diarrhoeal diseases are still the major paediatric health concern worldwide, contributing for 2.5 million annual deaths in children. Although the treatment of diarrhoeal illness as per the World Health Organization (WHO) guidelines brings about a considerable decline in the burden of the disease but there is still a lot to be done for this issue. Zinc supplementation along with Oral Rehydration Solution (ORS) has emerged as a potent approach to treat diarrhoea. It is believed that the children having zinc deficiency are at high risk of developing infectious diseases which eventually lead to a high burden of mortality.
In order to prevent and effectively manage diarrheal episodes, it is important that water purification tablets, zinc and oral rehydration salt is always available in each household. Though, these products are easily available in the market separately, but are rarely available together in any household. If these products are made available in a single packet, it is likely to be an effective strategy in combating diarrheal diseases in the community.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
Children, Recovery, Diarrhea Pack, Social Marketing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
A diarrhea Pack comprising of low osmolality ORS, Zinc, water purification sachets and pictorial chart.
Arm Title
Control
Arm Type
Other
Arm Description
Standard Care through National LHW (Lady Health Workers)program
Intervention Type
Other
Intervention Name(s)
Diarrhea Pack
Intervention Description
Low osmolality ORS, Zinc tablets, water purification tablets and pictorial chart
Intervention Type
Other
Intervention Name(s)
ORS
Intervention Description
ORS has been supplied to diarrheal cases as standard care through the LHW program at community level
Primary Outcome Measure Information:
Title
Reduction in Diarrhea related morbidity
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children under 5 years of age suffering from diarrhea residing in study area and having consent to participate
Exclusion Criteria:
Failure to provide consent or children having debilitating illness or requiring emergency hospital care.
Facility Information:
Facility Name
AKU Project Office
City
Khairpur
State/Province
Sind
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Community Based Intervention and Evaluation of the Impact of Social Marketing of a Diarrhea Management Pack
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