Community Resilience to Acute Malnutrition (CRAM)

February 26, 2018 updated by: Tufts University
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).

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

1420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sila Region
      • Goz Beida, Sila Region, Chad
        • Concern Worldwide Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Helen Young, DR, Tufts University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • A06/B14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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