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

Child Acute Malnutrition Clinical Trial

— PROMIS-Mali  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323815
• Other study ID #: IFPRI
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2014
• Last updated: March 8, 2018
• Start date: February 1, 2015
• Est. completion date: September 1, 2017

Study information

• Verified date: March 2018
• Source: International Food Policy Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2304
• Est. completion date: September 1, 2017
• Est. primary completion date: May 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 23 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Acute Malnutrition
• Child Nutrition Disorders
• Malnutrition

Intervention

Dietary Supplement:
• Small-Quantity Lipid-based nutrient supplement
A monthly dose of SQ-LNS (31 sachets of 20g) will be distributed to mothers attending counselling sessions

Behavioral:
• Child's health and nutrition topics
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.

Locations

Country	Name	City	State
Mali	Bla and San Health Districts	Bla And San	Segou

Sponsors (2)

Lead Sponsor	Collaborator
International Food Policy Research Institute	Helen Keller International

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of age	Cross-sectional study; To calculate WHZ scores the 2006 WHO growth reference will be used	After 24 months of program implementation
Primary	Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 6-23 months)	Cross-sectional study; Longitudinal study	monthly from study inclusion at 6 months to 23 months of age and at study endline
Primary	Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm	Longitudinal study; To calculate WHZ scores the 2006 WHO growth reference will be used	Monthly from study inclusion at 6 months to 23 months of age
Primary	Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)	Cross-sectional study; Longitudinal study	monthly from study inclusion at 6 months to 23 months of age and at study endline
Secondary	Prevalence of child stunting defined by HAZ<-2 in children 6-23 months of age	To calculate HAZ scores the 2006 WHO growth reference will be used	After 24 months of program implementation
Secondary	Mean WHZ-score in children 6-23 months of age	To calculate WHZ scores the 2006 WHO growth reference will be used	After 24 months of program implementation
Secondary	Mean HAZ-score in children 6-23 months of age	To calculate HAZ scores the 2006 WHO growth reference will be used	After 24 months of program implementation
Secondary	Mean Mid-Upper Arm Circumference in children 6-23 months of age		After 24 months of program implementation
Secondary	Mean hemoglobin concentration at endline in children 6-23 months of age		After 24 months of program implementation
Secondary	Prevalence of child anemia (Hb concentration<11g.dL-1) at endline in children 6-23 months of age		After 24 months of program implementation
Secondary	Prevalence of Severe Acute Malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm	To calculate WHZ scores the 2006 WHO growth reference will be used	After 24 months of program implementation
Secondary	Prevalence of severe stunting defined by a HAZ<-3 in children 6-23 months of age	To calculate HAZ scores the 2006 WHO growth reference will be used	After 24 months of program implementation
Secondary	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
Secondary	Incidence of child stunting defined by HAZ<-2 in children from 6 to 23 months of age	To calculate HAZ scores the 2006 WHO growth reference will be used	monthly from inclusion at 6 months to 23 months of age
Secondary	Linear growth velocity (HAZ increment/month)	To calculate HAZ scores the 2006 WHO growth reference will be used	monthly from inclusion at 6 months to 23 months
Secondary	Ponderal growth velocity (WHZ increment/month)	To calculate WHZ scores the 2006 WHO growth reference will be used	monthly from inclusion at 6 months to 23 months
Secondary	Weight gain (weight increment/month)		monthly from inclusion at 6 months to 23 months
Secondary	Mid-Upper Arm Circumference gain (MUAC increment /month)		monthly from inclusion at 6 months to 23 months
Secondary	Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)	Malaria will be tested in case of fever (or recalled fever over last 24 hrs) using rapid tests	monthly from inclusion at 6 months to 23 months
Secondary	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
Secondary	Child development (motor, language and personal-social development)	Determined by DMC-II	After 24 months of program implementation