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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02323815
Acronym
PROMIS-Mali
Enrollment
2304
Registered
2014-12-24
Start date
2015-02-01
Completion date
2017-09-01
Last updated
2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Acute Malnutrition

Keywords

child acute malnutrition prevention, behavior change communication, lipid-based nutrient supplement, screening coverage

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.

Interventions

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

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.

Sponsors

Helen Keller International
CollaboratorOTHER
International Food Policy Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 23 Months
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of ageAfter 24 months of program implementation* Cross-sectional study * To calculate WHZ scores the 2006 WHO growth reference will be used
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
Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mmMonthly 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
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

Secondary

MeasureTime frameDescription
Mean hemoglobin concentration at endline in children 6-23 months of ageAfter 24 months of program implementation
Prevalence of child anemia (Hb concentration<11g.dL-1) at endline in children 6-23 months of ageAfter 24 months of program implementation
Prevalence of Severe Acute Malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mmAfter 24 months of program implementationTo calculate WHZ scores the 2006 WHO growth reference will be used
Prevalence of severe stunting defined by a HAZ<-3 in children 6-23 months of ageAfter 24 months of program implementationTo 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
Incidence of child stunting defined by HAZ<-2 in children from 6 to 23 months of agemonthly from inclusion at 6 months to 23 months of ageTo calculate HAZ scores the 2006 WHO growth reference will be used
Prevalence of child stunting defined by HAZ<-2 in children 6-23 months of ageAfter 24 months of program implementationTo calculate HAZ scores the 2006 WHO growth reference will be used
Ponderal growth velocity (WHZ increment/month)monthly from inclusion at 6 months to 23 monthsTo calculate WHZ scores the 2006 WHO growth reference will be used
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)monthly from inclusion at 6 months to 23 monthsMalaria will be tested in case of fever (or recalled fever over last 24 hrs) using rapid tests
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 treatedmonthly from inclusion at 6 months to 23 months
Child development (motor, language and personal-social development)After 24 months of program implementationDetermined by DMC-II
Linear growth velocity (HAZ increment/month)monthly from inclusion at 6 months to 23 monthsTo calculate HAZ scores the 2006 WHO growth reference will be used
Mean WHZ-score in children 6-23 months of ageAfter 24 months of program implementationTo calculate WHZ scores the 2006 WHO growth reference will be used
Mean HAZ-score in children 6-23 months of ageAfter 24 months of program implementationTo calculate HAZ scores the 2006 WHO growth reference will be used
Mean Mid-Upper Arm Circumference in children 6-23 months of ageAfter 24 months of program implementation

Countries

Mali

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026