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

NCT ID: NCT02323815

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2017-09-01

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.

Conditions

Child Acute Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Child's health and nutrition topics

Intervention Type: 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.

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)

Group Type: EXPERIMENTAL

Small-Quantity Lipid-based nutrient supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Child's health and nutrition topics

Intervention Type: 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.

Interventions

Small-Quantity Lipid-based nutrient supplement

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

SQ-LNS

Eligibility Criteria

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

• 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

• Index child should not present congenital deformations that hamper anthropometric measurements

Longitudinal study

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helen Keller International

OTHER

Sponsor Role: collaborator

International Food Policy Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie Ruel, PhD

Role: STUDY_DIRECTOR

International Food Policy Research Institute

Harouna Konde, MD

Role: PRINCIPAL_INVESTIGATOR

Helen Keller International - Mali

Lieven Huybregts, PhD

Role: PRINCIPAL_INVESTIGATOR

International Food Policy Research Institute

Agnes Le Port

Role: PRINCIPAL_INVESTIGATOR

International Food Policy Research Institute

Locations

Bla and San Health Districts

Bla and San, Ségou, Mali

Countries

Mali

References

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.

Reference Type: DERIVED

PMID: 31454356 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28274214 (View on PubMed)

Other Identifiers

IFPRI

Identifier Type: -

Identifier Source: org_study_id