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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.

Primary Purpose

Malnutrition, Child

Status
Recruiting
Phase
Not Applicable
Locations
Angola
Study Type
Interventional
Intervention
Nutritional Supplementation
Money transfers
Standard intervention
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition, Child

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleAccepts 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).

Sites / Locations

  • CuneneRecruiting
  • Huíla provinceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard Intervention (CONTROL Arm)

Standard Intervention plus nutritional supplementation (CONTROL+NUT Arm)

Standard Intervention plus money transfers (CONTROL+TM Arm)

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

● 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.

Secondary Outcome Measures

● 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.
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
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.
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.
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
Cost-effectiveness incremental ratios (obtained dividing the incremental cost by the incremental benefit for health ).
The cost-effectiveness of different interventions will be measured.
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.

Full Information

First Posted
September 16, 2022
Last Updated
January 24, 2023
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Universidade Mandume Ya Ndemufayo, Fundo de Apoio Social, Instituto de Salud Carlos III, Acción Contra el Hambre
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1. Study Identification

Unique Protocol Identification Number
NCT05571280
Brief Title
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-benefit Community-based Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
Universidade Mandume Ya Ndemufayo, Fundo de Apoio Social, Instituto de Salud Carlos III, Acción Contra el Hambre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Intervention (CONTROL Arm)
Arm Type
Active Comparator
Arm 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.
Arm Title
Standard Intervention plus nutritional supplementation (CONTROL+NUT Arm)
Arm Type
Experimental
Arm 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.
Arm Title
Standard Intervention plus money transfers (CONTROL+TM Arm)
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional Supplementation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Money transfers
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard intervention
Intervention Description
The activities included are the following: Community interventions against malnutrition and promotion of adequate nutrition: raise awareness of malnutrition and training mothers to recognize signs of malnutrition. 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. Biannual supplementation with vitamin A for children from 6 to 24 months of age. Biannual deworming (albendazole/mebendazole) for children from 12 months to 24 months of age and pregnant women as of 2nd quarter. Malaria prophylaxis with sulfadoxine-pyrimethamine (SP) in pregnant women as of 13 weeks of pregnancy.
Primary Outcome Measure Information:
Title
● 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.
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
● 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.
Description
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.
Time Frame
0-1 and 24 months
Title
Mortality rate at 3, 6, 12, 18, and 24 months after enrollment in the study.
Description
Mortality will be assessed during all study at selected time frames
Time Frame
3, 6, 12, 18, and 24 months
Title
Incidence rate in relevant comorbidities
Description
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.
Time Frame
6, 12, 18, and 24 months
Title
Increment of food diversity grade at the end of the study compared to baseline.
Description
Attitudes and eating habits of families in the provinces of Huíla and Cunene will be quantified.
Time Frame
0-1 and 24 months
Title
Number of pre- and post-natal visits.
Description
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
Time Frame
6 months
Title
Cost-effectiveness incremental ratios (obtained dividing the incremental cost by the incremental benefit for health ).
Description
The cost-effectiveness of different interventions will be measured.
Time Frame
2 years
Title
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.
Description
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.
Time Frame
3, 6, 12, 18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Israel Molina
Phone
+34679337605
Email
israel.molina@vallhebron.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Trigo
Phone
+34649021539
Email
etrigoes@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Israel Molina
Organizational Affiliation
Vall d'Hebron Institut de Recerca (VHIR)
Official's Role
Study Chair
Facility Information:
Facility Name
Cunene
City
Otchinjau; Mupa
State/Province
Cunene
Country
Angola
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Esteban
Phone
+ 34 649 02 15 39
Email
etrigoes@gmail.com
Facility Name
Huíla province
City
Libongue; Jamba Sede
Country
Angola
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Esteban
Phone
+ 34 649 02 15 39
Email
etrigoes@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://crescerangola.com/
Description
Operational research against chronic child malnutrition in Angola (CRESCER Project)

Learn more about this trial

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.

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