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.

Vall d'Hebron University Hospital (HUVH)

Status: Active, not recruiting

Conditions: Malnutrition, Child

Treatments: Behavioral: Money transfers; Behavioral: Standard intervention; Dietary Supplement: Nutritional Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT05571280

MuCCUA

Details and patient eligibility

About

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.

Enrollment: 1,423 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,423 participants in 3 patient groups

Standard Intervention

Experimental group

Description:

The Standard package includes a series of actions carried out by the Community and Health Development Agents (ADECOS), who improves access to primary health care practices and promotes well-being behaviors at community levels. ADECOS has the potential to facilitate improvements in the health state and quality of life in rural communities. Activities performed by ADECOS can be grouped into two blocks: * Health awareness-raising, and promotion activities at the community level (against malnutrition and promoting adequate nutrition). * Preventive community activities involving the promotion of treatment against malnutrition at the community level and direct referral to local health facilities when necessary.

Treatment:

Behavioral: Standard intervention

Standard Intervention plus nutritional supplementation (Standard+NUT Arm)

Active Comparator group

Description:

In addition to the services performed by the ADECOS, it is included a supply of complementary food rations (individual + family) at the relative level, being: * One individual portion composed by nutritional lipid supplements in small quantities (SQ-LNS) * One complementary family portion composed by local foods.

Treatment:

Dietary Supplement: Nutritional Supplementation

Standard Intervention plus money transfers (Standard+TM Arm)

Experimental group

Description:

In addition to the services performed by the ADECOS, it will be delivered a total of 14,000.00 Kz per month and per relative with 4 or more people living in the same household by the end of the study. It will be delivered a total of 11,000.00 Kz per month and per relative with 3 or fewer people living in the same household by the end of the study. The monetary value will be delivered in cash with unconditional format, and it will not be determined by the investigator team the use and the destination of said amount and nothing will be requested in return.

Treatment:

Behavioral: Money transfers