Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03454100
Other study ID # A06/B14
Secondary ID
Status Completed
Phase N/A
First received February 9, 2018
Last updated February 26, 2018
Start date November 1, 2012
Est. completion date January 1, 2018

Study information

Verified date February 2018
Source Tufts University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 1420
Est. completion date January 1, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 59 Months
Eligibility 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 Design


Intervention

Behavioral:
multisectoral 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.

Locations

Country Name City State
Chad Concern Worldwide Office Goz Beida Sila Region

Sponsors (3)

Lead Sponsor Collaborator
Tufts University Concern Worldwide, Department for International Development, United Kingdom

Country where clinical trial is conducted

Chad, 

References & Publications (1)

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. 2016 Dec 8. pii: 0379572116681682. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Acute Malnutrition prevalence of wasting (weight for age z-score<-2) 5 years
Secondary Chronic Malnutrition prevalence of stunting (height for age z-score<-2) 5 years
Secondary height for age height for age z-score 5 years
Secondary child morbidity Child ill in the past two weeks 5 years
Secondary weight for height weight for height z-score 5 years
See also
  Status Clinical Trial Phase
Completed NCT05012592 - Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children by the School Nurses N/A
Completed NCT04216043 - Milk Matters in Malnutrition, is it the Lactose or Dairy Protein? N/A
Enrolling by invitation NCT05603793 - YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition
Completed NCT03573713 - Decreasing Stunting by Reducing Maternal Depression in Uganda: A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes N/A
Not yet recruiting NCT05792514 - The Reliable Nutritional Risk Screening Tools
Recruiting NCT04109352 - Labelled Carbon Sucrose Breath Test (13C-SBT) as a Marker of Environmental Enteropathy
Enrolling by invitation NCT03355313 - Use of Low-level Laser Therapy on Children Aged One to Five Years With Energy-protein Malnutrition N/A
Completed NCT05551819 - Acceptability of a Microbiome-directed Food in Young Children With Acute Malnutrition N/A
Completed NCT04101487 - Cash Transfers to Increase Dietary Diversity in Grand Gedeh County, Liberia N/A
Active, not recruiting NCT05571280 - Community-based, Controlled, Open-label, Cluster-randomized Trial for the Reduction of Chronic Malnutrition in Children Under Two Years of Age, With Three Intervention Arms Grouped by Clusters, in Two Provinces in Southern Angola, Huíla and Cunene. N/A
Withdrawn NCT05437068 - Nutritional Supplementation in Children at Risk of Undernutrition N/A
Recruiting NCT05442424 - Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii N/A
Completed NCT04896996 - The Effect of Continuous Egg Supplement on Personalized Nutri-omics in Primary School Children (SI-EGG STUDY) N/A
Not yet recruiting NCT06049680 - Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients Phase 4
Recruiting NCT06382857 - Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition N/A
Recruiting NCT05269992 - Childrens Real Food Tolerance Study N/A
Active, not recruiting NCT05123378 - Liberia National Community Health Assistant (NCHA) Program and Under-five Mortality N/A
Completed NCT04688515 - Effectiveness of a Positive Deviance Program in Reducing Childhood Undernutrition N/A
Not yet recruiting NCT04810468 - Study of Malnutrition in Primary School Children N/A
Completed NCT04334538 - Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition N/A