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

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.

Study Overview

• Status: Completed
• Conditions: Child Acute Malnutrition
• Intervention / Treatment: Behavioral: Child's health and nutrition topics; Dietary supplement: Small-Quantity Lipid-based nutrient supplement

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 Type: Interventional
• Enrollment (Anticipated): 2304
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mali
  • Segou
    • Bla And San, Segou, Mali
      • Bla and San Health Districts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 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	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.
Experimental: PROMIS intervention; 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)	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.; 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; Other Names: SQ-LNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Mean Mid-Upper Arm Circumference in children 6-23 months of age		After 24 months of program implementation
Mean hemoglobin concentration at endline in children 6-23 months of age		After 24 months of program implementation
Prevalence of child anemia (Hb concentration<11g.dL-1) at endline in children 6-23 months of age		After 24 months of program implementation
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
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
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
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
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
Weight gain (weight increment/month)		monthly from inclusion at 6 months to 23 months
Mid-Upper Arm Circumference gain (MUAC increment /month)		monthly from inclusion at 6 months to 23 months
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
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
Child development (motor, language and personal-social development)	Determined by DMC-II	After 24 months of program implementation

Collaborators and Investigators

• Sponsor: International Food Policy Research Institute
• Collaborators: Helen Keller International
• Investigators: Study Director: Marie Ruel, PhD, International Food Policy Research Institute; Principal Investigator: Harouna Konde, MD, Helen Keller International - Mali; Principal Investigator: Lieven Huybregts, PhD, International Food Policy Research Institute; Principal Investigator: Agnes Le Port, International Food Policy Research Institute

Publications and helpful links

General Publications

• Huybregts L, Becquey E, Zongrone A, Le Port A, Khassanova R, Coulibaly L, Leroy JL, Rawat R, Ruel MT. The impact of integrated prevention and treatment on child malnutrition and health: the PROMIS project, a randomized control trial in Burkina Faso and Mali. BMC Public Health. 2017 Mar 9;17(1):237. doi: 10.1186/s12889-017-4146-6.
• Huybregts L, Le Port A, Becquey E, Zongrone A, Barba FM, Rawat R, Leroy JL, Ruel MT. Impact on child acute malnutrition of integrating small-quantity lipid-based nutrient supplements into community-level screening for acute malnutrition: A cluster-randomized controlled trial in Mali. PLoS Med. 2019 Aug 27;16(8):e1002892. doi: 10.1371/journal.pmed.1002892. eCollection 2019 Aug.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): May 5, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: December 18, 2014
• First Submitted That Met QC Criteria: December 18, 2014
• First Posted (Estimate): December 24, 2014

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: behavior change communication; lipid-based nutrient supplement; screening coverage; child acute malnutrition prevention
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Child Nutrition Disorders
• Other Study ID Numbers: IFPRI