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

NCT02245152 | Completed Phase 4

• 2 other identifiers: IFPRI-2014-001DFATD
• Study Type: interventional
• Target: 2,400
• 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 often 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 0-17 months of age

  * Cross-sectional study * To calculate WHZ scores the 2006 WHO growth reference will be used * The MUAC criterion (125mm) is only used for children 6-17months of age

  After 24 months of program implementation

• Screening coverage of acute child malnutrition (proportion of children monthly screened / total number of eligible children (aged 0-17 months)

  * Cross-sectional study * Longitudinal study

  monthly from study inclusion at 0 months to 17 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 0 months to 17 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 0 months to 17 months of age and at study endline

Secondary Outcomes (16)

• Prevalence of child stunting defined by HAZ<-2 in children 0-17 months of age

  After 24 months of program implementation

• Mean WHZ-score in children 0 -17 months of age

  After 24 months of program implementation

• Mean HAZ-score in children 0-17 months of age

  After 24 months of program implementation

• Mean mid-upper arm circumference in children 0-17 months of age

  After 24 months of program implementation

• Mean hemoglobin concentration in children 3-17 months of age

  After 24 months of program implementation

Study Arms (2)

PROMIS intervention

EXPERIMENTAL

* Small group 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 well-baby visits for children 0-17 months of age * Caregivers with children 0-17 months of age that attend the well-baby visit will be provided with a monthly dose of LNS (20g/day)

Dietary Supplement: LNS; Behavioral: Child's health and nutrition topics; Behavioral: National policy well-baby visits

control

ACTIVE COMPARATOR

Monthly well-baby visits as prescribed by national policy This arm is the basic comparison arm. Caregivers are invited to frequent the health center once a month for well-baby visits. During these visits necessary vaccinations are administered, child growth and nutrition status is evaluated and preventive counseling on child nutrition and health is provided in large groups of caregivers.

Behavioral: National policy well-baby visits

Interventions

LNS DIETARY_SUPPLEMENT

A monthly dose of LNS (31 sachets of 20g) will be distributed to mothers attending well-baby visits and participating in small group counseling

Also known as: Lipid-based nutrient supplement (LNS)

PROMIS intervention

Child's health and nutrition topics BEHAVIORAL

After the well-baby visit. Caregivers will be invited to participate in a small group counseling or BCC (2-3 caregivers at a time). Every month a set of topics related to child's health and nutrition will be treated. These BCC sessions will be organized in an interactive way centering around the condition of the participating children.

PROMIS intervention

National policy well-baby visits BEHAVIORAL

PROMIS intervention; control

Eligibility Criteria

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

You may qualify if:

• At least one index child 0-17 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 (n=2,180)
• child 0-1.4 months of age;
• 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 area in the coming year
• WHZ\<-2 both at enrollment and at the first follow-up.

Sponsors & Collaborators

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

Study Sites (1)

Gourcy Health District

Gourcy, Région Du Nord, Burkina Faso

Location

Related Publications (2)

• Becquey E, Huybregts L, Zongrone A, Le Port A, Leroy JL, Rawat R, Toure M, Ruel MT. Impact on child acute malnutrition of integrating a preventive nutrition package into facility-based screening for acute malnutrition during well-baby consultation: A cluster-randomized controlled trial in Burkina Faso. PLoS Med. 2019 Aug 27;16(8):e1002877. doi: 10.1371/journal.pmed.1002877. eCollection 2019 Aug.

  PMID: 31454347 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

  PRINCIPAL INVESTIGATOR

• Jean-Celestin Somda, MD

  Helen Keller International

  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: September 16, 2014
• First Posted: September 19, 2014
• Study Start: October 6, 2014
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 9, 2018

Record last verified: 2017-03

Locations

BU (1)