- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03454100
Community Resilience to Acute Malnutrition (CRAM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Concern Worldwide has developed a model of intervention called Community Resilience to Acute Malnutrition (CRAM). This model is based on the need for (a) the introduction of longer-term programming to build community resilience to shocks, while recognising that there may be a need for humanitarian intervention, and (b) a multi-sectoral package of activities given experience in programming from other settings. The goal of the study is to rigorously test the impact of the model and associated activities on community resilience to shocks in the Goz Beida area of Chad. Where community resilience is proxied by the primary outcome variable: acute malnutrition.
In order to answer this question, 69 villages had been randomized to either receive the full multi-sectoral program or not. In each village, approximately 20 households were surveyed (randomly selected from a household list from a previous emergency distribution) for a total of 1420 households. Those households were then surveyed in November/December 2012 (prior to the intervention), and again a the same time period in 2014, 2015, and 2017.
Data was collected on household demographics, livelihoods, child health, and nutrition, including child (6-59 months) anthropometry.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sila Region
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Goz Beida, Sila Region, Chad
- Concern Worldwide Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- child is from household with B, C, or D wealth ranking (wealth ranking is from A-D with A being the highest wealth and D being the lowest wealth)
- child is between the ages of 6-59 months
- child is present in the selected household at the time of the survey
Exclusion Criteria:
- child has a skin disorder
- too ill to be measured on height board or weight scale
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: multi-sectoral package of activities
Villages in the experimental arm received the full multi-sectoral package of village level activities, including having a well dug, a shared latrine installed, training on handwashing and hygiene across the water chain, training on conservation agriculture techniques, care groups for pregnant and breastfeeding mothers, and training on market gardens.
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A multi-sectoral package of village level activities, including having a well dug, a shared latrine installed, training on handwashing and hygiene across the water chain, training on conservation agriculture techniques, care groups for pregnant and breastfeeding mothers, and training on market gardens.
|
No Intervention: Control
Villages in the control arm did not receive teh multi-sectoral package of village level activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Malnutrition
Time Frame: 5 years
|
prevalence of wasting (weight for age z-score<-2)
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic Malnutrition
Time Frame: 5 years
|
prevalence of stunting (height for age z-score<-2)
|
5 years
|
height for age
Time Frame: 5 years
|
height for age z-score
|
5 years
|
child morbidity
Time Frame: 5 years
|
Child ill in the past two weeks
|
5 years
|
weight for height
Time Frame: 5 years
|
weight for height z-score
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Helen Young, DR, Tufts University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A06/B14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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