Malnutrition, Child Clinical Trial
Official title:
Maternal and Child Interventions Against Chronic Malnutrition in Angola. A Cluster-randomized Cost-benefit Community-based Study.
Verified date | October 2023 |
Source | Hospital Universitari Vall d'Hebron Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 1423 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Angola | Huíla province | Libongue; Jamba Sede | |
Angola | Cunene | Otchinjau; Mupa | Cunene |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari Vall d'Hebron Research Institute | Acción Contra el Hambre, Fundo de Apoio Social, Instituto de Salud Carlos III, Universidade Mandume Ya Ndemufayo |
Angola,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ? 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. | Effectiveness of three interventions (standard care, money transfers, and nutritional supplements) to reduce chronic malnutrition in children under two years of age in the provinces of Huíla and Cunene by the proportion of children with different degrees of malnutrition. | 24 months | |
Secondary | ? 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. | Effectiveness of three interventions (standard care, money transfers, and nutritional supplements) individually to reduce chronic malnutrition in children under 5 years of age in the provinces of Huíla and Cunene will be assessed by measuring height/length per age score. | 0-1 and 24 months | |
Secondary | Mortality rate at 3, 6, 12, 18, and 24 months after enrollment in the study. | Mortality will be assessed during all study at selected time frames | 3, 6, 12, 18, and 24 months | |
Secondary | Incidence rate in relevant comorbidities | Incidence of malaria, pneumonia, diarrhea, and anemia (Hemoglobin < 12g/dL) in children up to 2 years of age in the provinces of Huíla and Cunene will be measured. | 6, 12, 18, and 24 months | |
Secondary | Increment of food diversity grade at the end of the study compared to baseline. | Attitudes and eating habits of families in the provinces of Huíla and Cunene will be quantified. | 0-1 and 24 months | |
Secondary | Number of pre- and post-natal visits. | Pre- and post-natal care indicators such as exclusive breastfeeding rate in children up to 6 months of age and low birth weight will be assessed | 6 months | |
Secondary | Cost-effectiveness incremental ratios (obtained dividing the incremental cost by the incremental benefit for health ). | The cost-effectiveness of different interventions will be measured. | 2 years | |
Secondary | 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. | Effectiveness of three interventions (standard care, money transfers, and nutritional supplements) to reduce chronic malnutrition in children under two years of age in the provinces of Huíla and Cunene by the proportion of children with different degrees of malnutrition. | 3, 6, 12, 18 months |
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