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CompletedNCT03454100CRAMUpdated Mar 5, 2018

Community Resilience to Acute Malnutrition

An interventional study of multisectoral package of activities in Malnutrition, Child, sponsored by Tufts University. Completed at 1 site in Chad. Open to participants aged 6 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by Tufts University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,420
Allocation
Randomized
Ages
6 Months to 59 Months
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Malnutrition, Child
03

Who can participate

Ages eligible
6 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • child has a skin disorder
  • too ill to be measured on height board or weight scale
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,420 participants (actual)

Study arms

  • 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.

    Behavioral: multisectoral package of activities

  • No intervention
    Control

    Villages in the control arm did not receive teh multi-sectoral package of village level activities.

Interventions

  • Behavioralmultisectoral package of activities

    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.

05

What researchers measure

Primary outcomes

  1. Acute Malnutrition

    prevalence of wasting (weight for age z-score\<-2)

    Time frame: 5 years

Secondary outcomes

  1. Chronic Malnutrition

    prevalence of stunting (height for age z-score\<-2)

    Time frame: 5 years

  2. height for age

    height for age z-score

    Time frame: 5 years

  3. child morbidity

    Child ill in the past two weeks

    Time frame: 5 years

  4. weight for height

    weight for height z-score

    Time frame: 5 years

06

Study locations

1 site
  • Concern Worldwide Office
    Goz Beida, Sila Region, Chad
07

References and documents

Publications

  • 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. PubMed 27932595 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03454100
Lead sponsor
Tufts University
Collaborators
Concern Worldwide, Department for International Development, United Kingdom
Responsible party
Sponsor
First posted
Mar 5, 2018
Start date
Nov 1, 2012
Primary completion
Jan 1, 2018
Completion
Jan 1, 2018
Last update
Mar 5, 2018

Study contacts

Helen Young, DR
principal investigator · Tufts University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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