Preventing Malnutrition in Children Under Two Years of Age Approach

International Food Policy Research Institute

Status: Completed

Conditions: Malnutrition

Treatments: Other: Procomida (Guatemala); Other: Tubaramure (Burundi)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01072279

4001-IFPRI-00

Details and patient eligibility

About

A study conducted by IFPRI in Haiti provided the first programmatic evidence, using a cluster randomized evaluation design, that preventing child undernutrition in children under two years of age (PM2A) through an integrated program providing food rations, BCC and preventive health and nutrition services is both feasible and highly effective. The study's principal aim was to compare a newly designed preventive approach with the traditional (recuperative) food assisted MCHN program approach, and therefore included only two comparison groups: one group of communities that was randomly assigned to the preventive approach and another group assigned to the recuperative approach. For logistical and financial reasons, the study did not include a randomized control group receiving no intervention.

The Haiti study design was well-suited to achieve its main goal - i.e. to test whether the preventive approach was more effective than the recuperative approach at preventing child undernutrition - but it left a number of questions unanswered.

The present study will address several of these questions, which will allow to further refine the PM2A approach, facilitate its replication in different contexts, and maximize its impact and cost-effectiveness in future programming. The study will be conducted in Guatemala and Burundi. The key research objectives are:

1. Impact and cost effectiveness: Assess the impact and cost effectiveness of PM2A on child nutritional status.
2. Optimal composition and size of food rations in PM2A: Assess the differential and absolute impact of varying the size and types of foods incorporated in the food ration of the PM2A. More specifically, assess the differential effect of different sizes of family food rations, and assess the impact of substituting the individual food ration with new micronutrient-rich products such as lipid-based nutrient supplements (LNS) or micronutrient Sprinkles.
3. Optimal timing and duration of PM2A: Assess the differential and absolute impact of varying the timing and duration of exposure to PM2A on child nutritional status.

Enrollment: 16,895 patients

Sex: All

Ages: Under 42 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Guatemala: pregnant mothers and subsequently their born children up to the age of 24 months;
• Burundi: cross-sectional study: children 0 to 42 of age.

Exclusion criteria

• none

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16,895 participants in 10 patient groups

Burundi: T24

Experimental group

Treatment:

Other: Tubaramure (Burundi)

Burundi: TNFP

Experimental group

Treatment:

Other: Tubaramure (Burundi)

Burundi: T18

Experimental group

Treatment:

Other: Tubaramure (Burundi)

Burundi: Control

No Intervention group

Guatemala: PROCOMIDA

Experimental group

Treatment:

Other: Procomida (Guatemala)

Guatemala: no family ration

Experimental group

Treatment:

Other: Procomida (Guatemala)

Guatemala: LNS

Experimental group

Treatment:

Other: Procomida (Guatemala)

Guatemala: Sprinkles

Experimental group

Treatment:

Other: Procomida (Guatemala)

Guatemala: reduced family ration

Experimental group

Treatment:

Other: Procomida (Guatemala)

Guatemala: control

No Intervention group