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. - Trial NCT05571280

Timeline & Enrollment

Primary Outcome

● Proportion of children with moderate an serious chronic malnutrition (indices below -2 and -3 Z- scores below the reference median) at 24 months of age in the provinces of Huíla and Cunene.

Summary

The severity of the stunting in the provinces of Huíla and Cunene, Angola, in children aged 6
 to 59 months is considered to be very high, as defined by the World Health Organization (WHO)
 classification of 2018. Some of the strategies that present promising results in the fight
 against chronic malnutrition have been specific nutritional interventions and money
 transfers. Among these, those that have so far had a greater impact in reducing chronic
 malnutrition indicators are fortified foods and lipid-based nutrient supplementation in small
 amounts.
 
 The hypothesis of the study is that these interventions applied from pregnancy can
 significantly reduce chronic malnutrition, each of which may have different impacts.
 
 The study intends, therefore, to evaluate an intervention that aims to obtain the highest
 quality scientific evidence on the best package of sensitive and specific measures that
 reduce chronic malnutrition and mortality in children under 2 years of age, maintaining the
 fundamental premises of sustainability, cost-benefit ratio, and scalability for other regions
 of the country.
 
 To this end, it was designed a community trial randomized by clusters in which different
 strategies will be evaluated separately:
 
 - Standard Intervention (CONTROL Arm) The Standard package includes a series of actions
 carried out by Community and Health Development Agents (ADECOS), which are characterized
 by having demonstrated strong evidence of their effectiveness in the scientific
 literature, and are part of the WHO guidelines and national health guidelines in
 different countries, including Angola.
 
 - CONTROL+ NUT (Nutrients Arm): Standard Intervention plus nutritional supplementation
 
 - CONTROL+ TM (Money transfers Arm): Standard Intervention plus money transfers
 
 Study population: pregnant women with more than 16 years of age; however the target
 population of the interventions will be the household where the pregnant woman lives. The
 impacts of interventions on indicators of chronic malnutrition in children under 5 years of
 age belonging to the household will also be analyzed.

ICD-10 Classifications