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

NCT02323815 | Completed Phase 4

• 1 other identifier: IFPRI
• Study Type: interventional
• Target: 2,304
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Acute Malnutrition

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (17)

• Prevalence of child stunting defined by HAZ<-2 in children 6-23 months of age

  After 24 months of program implementation

• Mean WHZ-score 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

• 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

Study Arms (2)

Control

ACTIVE COMPARATOR

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

PROMIS intervention

EXPERIMENTAL

* 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)

Dietary Supplement: Small-Quantity Lipid-based nutrient supplement; Behavioral: Child's health and nutrition topics

Interventions

Small-Quantity Lipid-based nutrient supplement DIETARY_SUPPLEMENT

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

Also known as: SQ-LNS

PROMIS intervention

Child's health and nutrition topics BEHAVIORAL

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.

Control; PROMIS intervention

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Index child should not present congenital deformations that hamper anthropometric measurements
• Longitudinal study
• 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
• Congenital malformations that make anthropometric measurements impossible
• Mother planning to leave the study are in the coming year

Sponsors & Collaborators

• International Food Policy Research Institute: lead
• Helen Keller International: collaborator

Study Sites (1)

Bla and San Health Districts

Bla and San, Ségou, Mali

Location

Related Publications (2)

• 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.

  PMID: 31454356 DERIVED

• 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.

  PMID: 28274214 DERIVED

Study Officials

• Marie Ruel, PhD

  International Food Policy Research Institute

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 24, 2014
• Study Start: February 1, 2015
• Primary Completion: May 5, 2017
• Study Completion: September 1, 2017
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

MA (1)