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

International Food Policy Research Institute

Status and phase: Completed; Phase 4

Conditions: Child Acute Malnutrition

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02245152

DFATD (Other Grant/Funding Number)

IFPRI-2014-001

Details and patient eligibility

About

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.

Full 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. A repeated cross-sectional study design among children 0-17 months, at baseline and at study endline (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 proposed study design entails a longitudinal design whereby individual children will be recruited at birth and followed-up monthly until they reach 18 months of age. We anticipate needing approximately 5 months to recruit the required number of children (estimated at 2,040- 1,020 in the control group and 1,020 in the intervention group). This design will allow us to assess the intervention's effects on the incidence, recovery and recurrence rates of MAM/SAM.

Enrollment: 2,400 estimated patients

Sex: All

Ages: Under 17 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Cross-sectional study (baseline and endline) (n=2,310)

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Longitudinal study (n=2,180)

Inclusion Criteria:

• child 0-1.4 months of age;
• 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 area in the coming year
• Children of 1.5 month of age or older at study inclusion
• WHZ<-2 both at enrollment and at the first follow-up.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,400 participants in 2 patient groups

PROMIS intervention

Experimental group

Description:

* 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)

Treatment:

Behavioral: Child's health and nutrition topics

Behavioral: National policy well-baby visits

Dietary Supplement: LNS

control

Active Comparator group

Description:

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.

Treatment:

Behavioral: National policy well-baby visits