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Completed

NCT Number: NCT02323815

The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Mali: a Cluster Randomized Intervention Study

Globally, child undernutrition is the underlying cause for 3.1 million deaths of children younger than 5 years. 18.7 million children under five years of age suffer from severe acute malnutrition (SAM) and an additional 33 million children suffer from moderate acute malnutrition, and are at risk of developing SAM

In Sub-Saharan Africa, there is often poor integration between programs to treat child acute malnutrition and programs that focus on the prevention of acute and chronic undernutrition - resulting in many missed opportunities for using prevention platforms to screen and refer SAM children, or for using screening and referral platforms to provide prevention services.

This project will address two critical gaps related to the integration of preventive and treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically integrated into routine health-center visits or mainstreamed into community outreach programs; and 2) screening programs do not offer any preventive services for those children found not to be suffering from MAM/SAM at the time of screening; mothers of children identified as non-MAM/SAM case are usually sent home without receiving any health or nutrition inputs and as a result, may fail to come back for screening because they do not see any tangible benefit associated with their participation in the screening. This project will specifically address these gaps by assessing the effect of an integrated approach consisting of higher screening coverage and preventive Behavior Change Communication (BCC) + Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment of child undernutrition.

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Key information

Conditions

Child Acute Malnutrition

Age range

6 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bla and San Health Districts

Bla and San, Ségou, Mali

About this study

Because of the intended dual role of BCC/SQ-LNS on child undernutrition in this study - e.g. to help prevent child undernutrition and enhance the coverage of screening, referral and treatment of SAM/MAM, it is necessary to combine two study designs to rigorously evaluate the impact of the proposed intervention and to tease out the contribution of prevention and enhanced coverage/treatment to the overall impact on child malnutrition.

The proposed study will therefore use two types of study designs. The first one is a repeated cross-sectional design that will compare select study outcomes between intervention and control groups at endline, after 24 months of program implementation. These cross-sectional surveys among children 6-23 months, at baseline and after 24 months (on different children) will be used to assess the impact of the intervention on the prevalence of several outcomes, including the prevalence of MAM/SAM and stunting, the coverage of MAM/SAM screening and maternal ENA/IYCF/WASH knowledge and practices. The second study design entails a longitudinal design whereby individual children will be recruited at 6 months of age and followed-up monthly until they reach 24 months of age.This design will allow us to assess the intervention's effects on the incidence, recovery and recurrence rates of MAM/SAM.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Cross-sectional study (baseline and endline)

Inclusion criteria

  • At least one index child 6-23 months of age in the household
  • Mother should be living in the study area since the index child's delivery
  • Singleton infants

Exclusion criteria

  • Index child should not present congenital deformations that hamper anthropometric measurements

Longitudinal study

Inclusion criteria

  • Child 6-6.9 months of age;
  • Child with WHZ>-2 and MUAC>125 mm and no bilateral pitting edema
  • Mother should be living in the study area since the index child's delivery
  • Singleton infants

Exclusion criteria

  • Congenital malformations that make anthropometric measurements impossible
  • Mother planning to leave the study are in the coming year

Treatment and study plan

Small-quantity lipid-based nutrient supplement

Dietary Supplement

A monthly dose of SQ-LNS (31 sachets of 20g) will be distributed to mothers attending counselling sessions

Other names: SQ-LNS

Child's health and nutrition topics

Behavioral

Monthly group counselling meetings organized at village level. Caregivers of participating children are invited to attend monthly counselling meetings that treat topics on child nutrition, health, hygiene and good sanitary practices. During these visits children are also screened for acute malnutrition measuring arm circumference.

Primary outcomes

  1. Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of age

    Time frame: After 24 months of program implementation

    • Cross-sectional study
    • To calculate WHZ scores the 2006 WHO growth reference will be used

  2. Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 6-23 months)

    Time frame: monthly from study inclusion at 6 months to 23 months of age and at study endline

    • Cross-sectional study
    • Longitudinal study

  3. Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm

    Time frame: Monthly from study inclusion at 6 months to 23 months of age

    • Longitudinal study
    • To calculate WHZ scores the 2006 WHO growth reference will be used

  4. Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)

    Time frame: monthly from study inclusion at 6 months to 23 months of age and at study endline

    • Cross-sectional study
    • Longitudinal study

Secondary outcomes

  1. Prevalence of child stunting defined by HAZ<-2 in children 6-23 months of age

    Time frame: After 24 months of program implementation

    To calculate HAZ scores the 2006 WHO growth reference will be used

  2. Mean WHZ-score in children 6-23 months of age

    Time frame: After 24 months of program implementation

    To calculate WHZ scores the 2006 WHO growth reference will be used

  3. Mean HAZ-score in children 6-23 months of age

    Time frame: After 24 months of program implementation

    To calculate HAZ scores the 2006 WHO growth reference will be used

  4. Mean Mid-Upper Arm Circumference in children 6-23 months of age

    Time frame: After 24 months of program implementation

  5. Mean hemoglobin concentration at endline in children 6-23 months of age

    Time frame: After 24 months of program implementation

  6. Prevalence of child anemia (Hb concentration<11g.dL-1) at endline in children 6-23 months of age

    Time frame: After 24 months of program implementation

  7. Prevalence of Severe Acute Malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm

    Time frame: After 24 months of program implementation

    To calculate WHZ scores the 2006 WHO growth reference will be used

  8. Prevalence of severe stunting defined by a HAZ<-3 in children 6-23 months of age

    Time frame: After 24 months of program implementation

    To calculate HAZ scores the 2006 WHO growth reference will be used

  9. Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), Essential Nutrition Actions (ENA) and Water, Sanitation and Hygiene (WASH)

    Time frame: After 24 months of program implementation

  10. Incidence of child stunting defined by HAZ<-2 in children from 6 to 23 months of age

    Time frame: monthly from inclusion at 6 months to 23 months of age

    To calculate HAZ scores the 2006 WHO growth reference will be used

  11. Linear growth velocity (HAZ increment/month)

    Time frame: monthly from inclusion at 6 months to 23 months

    To calculate HAZ scores the 2006 WHO growth reference will be used

  12. Ponderal growth velocity (WHZ increment/month)

    Time frame: monthly from inclusion at 6 months to 23 months

    To calculate WHZ scores the 2006 WHO growth reference will be used

  13. Weight gain (weight increment/month)

    Time frame: monthly from inclusion at 6 months to 23 months

  14. Mid-Upper Arm Circumference gain (MUAC increment /month)

    Time frame: monthly from inclusion at 6 months to 23 months

  15. Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)

    Time frame: monthly from inclusion at 6 months to 23 months

    Malaria will be tested in case of fever (or recalled fever over last 24 hrs) using rapid tests

  16. Relapse rate after treatment of MAM/SAM (proportion WHZ<-2 or MUAC<125mm or bilateral pitting edema after discharge from MAM or SAM treatment program over a total number of children treated

    Time frame: monthly from inclusion at 6 months to 23 months

  17. Child development (motor, language and personal-social development)

    Time frame: After 24 months of program implementation

    Determined by DMC-II

Sponsors and collaborators

Lead sponsor

International Food Policy Research Institute

Other

Collaborators

  • Helen Keller International

Registry information

Acronym: PROMIS-Mali

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 24, 2014
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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