Clinical trial 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.
Official title: Maternal and Child Interventions Against Chronic Malnutrition in Angola. A Cluster-randomized Cost-effectiveness Community-based Study.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malnutrition, Child
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
name: Action Contre la Faim
First posted: 2022-10-07
Enrollment: 1423
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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 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.
* Standard+ NUT (Nutrients Arm - Control Arm): Standard Intervention plus nutritional supplementation
* Standard+ 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.


Eligibility criteria: Inclusion Criteria:

* Women of 16 years of age or older;
* Pregnancy confirmed through a test;
* Accept to participate in the study upon the informed consent form is signed by the community leader and confirmed by potential participants.

Exclusion Criteria:

* Women of 16 years of age or older, pregnant, who do not belong to the pre-selected districts/villages of the study;
* Women that, although in the household, are maids, reside in rented homes or are temporary visits;
* Women who have planned to travel or move outside of the district within the study follow-up period;
* Women who manifest the impossibility of completing follow-up visits;
* Alcohol-dependent women or with a history of alcohol abuse (considered as intake of \>3 drinks on any day or \>7 drinks per week);
* Any condition that, at the investigator's discretion, is non-compliant with interventions or follow-up controls;
* Pregnant women with acute malnutrition (brachial circumference \< 21 cm).

Primary outcomes:
measure: ● 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.
timeFrame: 24 months
Secondary outcomes:
measure: ● Proportion of children under 5 years of age with moderate and severe chronic malnutrition (indices below -2 and -3 Z-scores below the reference median) at the beginning and end of the study in the provinces of Huíla and Cunene.
timeFrame: 0-1 and 24 months
measure: Mortality rate at 3, 6, 12, 18, and 24 months after enrollment in the study.
timeFrame: 3, 6, 12, 18, and 24 months
measure: Incidence rate in relevant comorbidities
timeFrame: 6, 12, 18, and 24 months
measure: Increment of food diversity grade at the end of the study compared to baseline.
timeFrame: 0-1 and 24 months
measure: Number of pre- and post-natal visits.
timeFrame: 6 months
measure: Cost-effectiveness incremental ratios (obtained dividing the incremental cost by the incremental benefit for health ).
timeFrame: 2 years
measure: Proportion of children with moderate and severe chronic malnutrition (indices below -2 and -3 Z- scores below the reference median) at 3, 6, 12, 18, months of age in the provinces of Huíla and Cunene.
timeFrame: 3, 6, 12, 18 months
Other outcomes:
Locations:
city: Otchinjau; Mupa
country: Angola
facility: Cunene
state: Cunene
city: Libongue; Jamba Sede
country: Angola
facility: Huíla province
Study officials:
affiliation: Vall d'Hebron Institut de Recerca (VHIR)
name: Israel Molina
role: STUDY_CHAIR
References: