Community Resilience to Acute Malnutrition (CRAM)
Primary Purpose
Malnutrition, Child
Status
Completed
Phase
Not Applicable
Locations
Chad
Study Type
Interventional
Intervention
multisectoral package of activities
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition, Child
Eligibility Criteria
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
Sites / Locations
- Concern Worldwide Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
multi-sectoral package of activities
Control
Arm Description
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.
Villages in the control arm did not receive teh multi-sectoral package of village level activities.
Outcomes
Primary Outcome Measures
Acute Malnutrition
prevalence of wasting (weight for age z-score<-2)
Secondary Outcome Measures
Chronic Malnutrition
prevalence of stunting (height for age z-score<-2)
height for age
height for age z-score
child morbidity
Child ill in the past two weeks
weight for height
weight for height z-score
Full Information
NCT ID
NCT03454100
First Posted
February 9, 2018
Last Updated
February 26, 2018
Sponsor
Tufts University
Collaborators
Concern Worldwide, Department for International Development, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT03454100
Brief Title
Community Resilience to Acute Malnutrition
Acronym
CRAM
Official Title
Community Resilience to Acute Malnutrition
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2012 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University
Collaborators
Concern Worldwide, Department for International Development, United Kingdom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study evaluates the impact of a multi-sectoral intervention (water, sanitation, and hygiene; training on climate smart activities; care groups for mothers; market gardens) on the prevalence of acute malnutrition as the primary outcome using a randomized intervention trial between 2012-2017 with four points of data collection (2012, 2014, 2015, and 2017).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Panel cluster randomized intervention trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
multi-sectoral package of activities
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Villages in the control arm did not receive teh multi-sectoral package of village level activities.
Intervention Type
Behavioral
Intervention Name(s)
multisectoral package of activities
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute Malnutrition
Description
prevalence of wasting (weight for age z-score<-2)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Chronic Malnutrition
Description
prevalence of stunting (height for age z-score<-2)
Time Frame
5 years
Title
height for age
Description
height for age z-score
Time Frame
5 years
Title
child morbidity
Description
Child ill in the past two weeks
Time Frame
5 years
Title
weight for height
Description
weight for height z-score
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Young, DR
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Concern Worldwide Office
City
Goz Beida
State/Province
Sila Region
Country
Chad
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27932595
Citation
Marshak A, Young H, Bontrager EN, Boyd EM. The Relationship Between Acute Malnutrition, Hygiene Practices, Water and Livestock, and Their Program Implications in Eastern Chad. Food Nutr Bull. 2017 Mar;38(1):115-127. doi: 10.1177/0379572116681682. Epub 2016 Dec 8.
Results Reference
result
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Community Resilience to Acute Malnutrition
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