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.

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.

Conditions

• Malnutrition, Child

Interventions

DIETARY_SUPPLEMENT

Nutritional Supplementation

The Small-quantity lipid-based nutrient supplementation (SQ-LNS) consists of micronutrients delivered in a lipid-based vehicle. All pregnant women (as of 12 weeks self-referred) within households who were randomly included in the study in the nutritional supplementation arm and their children as of 6 months of age will receive the SQ-LNS. ● Pregnant women: 20-g sachets, 20 g (1 sachet) dose per day. Nutritional composition and caloric intake. Total = 12/13 months approximately. ● Children from 6 months of age: 20-g sachets, 20 g (1 sachet) dose per day. Nutritional composition and caloric intake. Total = 18 months. The distribution will be made by ADECOS on a fortnightly basis. A family ration will be distributed: family supplementation is presented in a basket of locally produced basic foods that complement the usual diet. The caloric distribution of the basket will be 45% of cereals, 30% of pulses, and 25% in oil, and 1 kg of iodized salt.

BEHAVIORAL

Money transfers

The distribution of the amounts will be made through the corresponding financial providers, together with the Municipal or Communal Administration authorities, the Assistants of Community Activities, the Investigator's personnel, and the ADECOS. The distribution frequency will be every 3 months until the end of the study.

BEHAVIORAL

Standard intervention

The activities included are the following: 1. Community interventions against malnutrition and promotion of adequate nutrition: raise awareness of malnutrition and training mothers to recognize signs of malnutrition. 2. Community interventions in promoting hygiene and proper sanitation: a) Promotion of Community-Led Total Sanitation approach (CLTS)strategy: community awareness of the entire population included in the cluster about the dangers of open defecation, and the direct link to malnutrition; b) Promotion of Baby-Wash strategy: to make the community aware of the problems and consequences of unsafe water consumption. 3. Biannual supplementation with vitamin A for children from 6 to 24 months of age. 4. Biannual deworming (albendazole/mebendazole) for children from 12 months to 24 months of age and pregnant women as of 2nd quarter. 5. Malaria prophylaxis with sulfadoxine-pyrimethamine (SP) in pregnant women as of 13 weeks of pregnancy.

Sponsors & Collaborators

• Carlos III Health Institute

  collaborator OTHER_GOV

• Action Contre la Faim

  collaborator OTHER

• Hospital Universitari Vall d'Hebron Research Institute

  lead OTHER

Principal Investigators

• Israel Molina · Vall d'Hebron Institut de Recerca (VHIR)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-10

Primary Completion

2025-10-31

Completion

2026-07-31

Countries

• Angola