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

Phase 4

Completed

• Conditions: Child Acute Malnutrition
• Interventions: Dietary Supplement: Small-Quantity Lipid-based nutrient supplement; Behavioral: Child's health and nutrition topics

• Registration Number: NCT02323815
• Lead Sponsor: International Food Policy Research Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-24
• Study Start: 2015-02-01
• Primary Completion: 2017-05-05
• Study Completion: 2017-09-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2304

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PROMIS intervention	Small-Quantity Lipid-based nutrient supplement	* Behavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly meetings for children 6-23 months of age * Caregivers with children 6-23 months of age that attend Counselling meetings will be provided with a monthly dose of SQ-LNS (20g/day)
Control	Child's health and nutrition topics	Behavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly meetings for children 6-23 months of age
PROMIS intervention	Child's health and nutrition topics	* Behavior change communication (BCC) on Essential Nutrition Actions (ENA), Infant and Young Child Feeding (IYCF) and Water, sanitation and hygiene (WASH) is provided during monthly meetings for children 6-23 months of age * Caregivers with children 6-23 months of age that attend Counselling meetings will be provided with a monthly dose of SQ-LNS (20g/day)

Primary Outcome Measures

Name	Time	Method
Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)	monthly from study inclusion at 6 months to 23 months of age and at study endline	* Cross-sectional study; * Longitudinal study
Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 6-23 months)	monthly from study inclusion at 6 months to 23 months of age and at study endline	* Cross-sectional study; * Longitudinal study
Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of age	After 24 months of program implementation	* Cross-sectional study; * To calculate WHZ scores the 2006 WHO growth reference will be used
Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm	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

Secondary Outcome Measures

Name	Time	Method
Prevalence of child stunting defined by HAZ<-2 in children 6-23 months of age	After 24 months of program implementation	To calculate HAZ scores the 2006 WHO growth reference will be used
Mean hemoglobin concentration at endline in children 6-23 months of age	After 24 months of program implementation
Ponderal growth velocity (WHZ increment/month)	monthly from inclusion at 6 months to 23 months	To calculate WHZ scores the 2006 WHO growth reference will be used
Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)	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
Prevalence of Severe Acute Malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm	After 24 months of program implementation	To calculate WHZ scores the 2006 WHO growth reference will be used
Mid-Upper Arm Circumference gain (MUAC increment /month)	monthly from inclusion at 6 months to 23 months
Mean Mid-Upper Arm Circumference in children 6-23 months of age	After 24 months of program implementation
Incidence of child stunting defined by HAZ<-2 in children from 6 to 23 months of age	monthly from inclusion at 6 months to 23 months of age	To calculate HAZ scores the 2006 WHO growth reference will be used
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	monthly from inclusion at 6 months to 23 months
Mean WHZ-score in children 6-23 months of age	After 24 months of program implementation	To calculate WHZ scores the 2006 WHO growth reference will be used
Prevalence of child anemia (Hb concentration<11g.dL-1) at endline in children 6-23 months of age	After 24 months of program implementation
Mean HAZ-score in children 6-23 months of age	After 24 months of program implementation	To calculate HAZ scores the 2006 WHO growth reference will be used
Prevalence of severe stunting defined by a HAZ<-3 in children 6-23 months of age	After 24 months of program implementation	To calculate HAZ scores the 2006 WHO growth reference will be used
Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), Essential Nutrition Actions (ENA) and Water, Sanitation and Hygiene (WASH)	After 24 months of program implementation
Linear growth velocity (HAZ increment/month)	monthly from inclusion at 6 months to 23 months	To calculate HAZ scores the 2006 WHO growth reference will be used
Weight gain (weight increment/month)	monthly from inclusion at 6 months to 23 months
Child development (motor, language and personal-social development)	After 24 months of program implementation	Determined by DMC-II

Trial Locations

Locations (1)

Bla and San Health Districts; 🇲🇱 Bla And San, Segou, Mali