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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
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition, Child

Eligibility Criteria

6 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

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

First Posted
February 9, 2018
Last Updated
February 26, 2018
Sponsor
Tufts University
Collaborators
Concern Worldwide, Department for International Development, United Kingdom
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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
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Community Resilience to Acute Malnutrition

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