Clinical trial NCT02323815: The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Mali: a Cluster Randomized Intervention Study
Official title: The Effect of Integrated Prevention and Treatment on Child Malnutrition and Health in Mali: a Cluster Randomized Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Child Acute Malnutrition
Keywords: child acute malnutrition prevention
behavior change communication
lipid-based nutrient supplement
screening coverage
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
Collaborators: name: Helen Keller International
First posted: 2014-12-24
Enrollment: 2304
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of acute child malnutrition defined by WHZ<-2 or MUAC <125mm or bilateral pitting edema in children 6-23 months of age
timeFrame: After 24 months of program implementation
measure: Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 6-23 months)
timeFrame: monthly from study inclusion at 6 months to 23 months of age and at study endline
measure: Incidence of child acute malnutrition defined by WHZ<-2 or MUAC<125mm
timeFrame: Monthly from study inclusion at 6 months to 23 months of age
measure: Compliance to treatment of acute malnutrition (% of cases that complete treatment over total admitted)
timeFrame: monthly from study inclusion at 6 months to 23 months of age and at study endline
Secondary outcomes:
measure: Prevalence of child stunting defined by HAZ<-2 in children 6-23 months of age
timeFrame: After 24 months of program implementation
measure: Mean WHZ-score in children 6-23 months of age
timeFrame: After 24 months of program implementation
measure: Mean HAZ-score in children 6-23 months of age
timeFrame: After 24 months of program implementation
measure: Mean Mid-Upper Arm Circumference in children 6-23 months of age
timeFrame: After 24 months of program implementation
measure: Mean hemoglobin concentration at endline in children 6-23 months of age
timeFrame: After 24 months of program implementation
measure: Prevalence of child anemia (Hb concentration<11g.dL-1) at endline in children 6-23 months of age
timeFrame: After 24 months of program implementation
measure: Prevalence of Severe Acute Malnutrition defined by a WHZ<-3 or bilateral pitting edema or a MUAC<115mm
timeFrame: After 24 months of program implementation
measure: Prevalence of severe stunting defined by a HAZ<-3 in children 6-23 months of age
timeFrame: After 24 months of program implementation
measure: Caregiver's knowledge and practices related to Infant and Young Child Feeding (IYCF), Essential Nutrition Actions (ENA) and Water, Sanitation and Hygiene (WASH)
timeFrame: After 24 months of program implementation
measure: Incidence of child stunting defined by HAZ<-2 in children from 6 to 23 months of age
timeFrame: monthly from inclusion at 6 months to 23 months of age
measure: Linear growth velocity (HAZ increment/month)
timeFrame: monthly from inclusion at 6 months to 23 months
measure: Ponderal growth velocity (WHZ increment/month)
timeFrame: monthly from inclusion at 6 months to 23 months
measure: Weight gain (weight increment/month)
timeFrame: monthly from inclusion at 6 months to 23 months
measure: Mid-Upper Arm Circumference gain (MUAC increment /month)
timeFrame: monthly from inclusion at 6 months to 23 months
measure: Infant morbidity (acute respiratory infections, fever, malaria (RDT), vomiting, diarrhea)
timeFrame: monthly from inclusion at 6 months to 23 months
measure: 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
timeFrame: monthly from inclusion at 6 months to 23 months
measure: Child development (motor, language and personal-social development)
timeFrame: After 24 months of program implementation
Other outcomes:
Locations:
city: Bla And San
country: Mali
facility: Bla and San Health Districts
state: Segou
Study officials:
affiliation: International Food Policy Research Institute
name: Marie Ruel, PhD
role: STUDY_DIRECTOR
affiliation: Helen Keller International - Mali
name: Harouna Konde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Food Policy Research Institute
name: Lieven Huybregts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Food Policy Research Institute
name: Agnes Le Port
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.