Preventing Malnutrition in Children Under Two Years of Age Approach

Study Overview
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Brief Summary
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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: Impact and cost effectiveness: Assess the impact and cost effectiveness of PM2A on child nutritional status. 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. 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.

Official Title
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Strengthening and Evaluating the Preventing Malnutrition in Children Under Two Years of Age Approach (PM2A) in Guatemala and Burundi

Conditions
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Malnutrition

Intervention / Treatment
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* Other: Tubaramure (Burundi)
* Other: Procomida (Guatemala)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 42 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Burundi: T24<br> | Other: Tubaramure (Burundi)<br>* Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices<br>|
| Experimental: Burundi: TNFP<br> | Other: Tubaramure (Burundi)<br>* Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices<br>|
| Experimental: Burundi: T18<br> | Other: Tubaramure (Burundi)<br>* Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices<br>|
| No Intervention: Burundi: Control<br> | |
| Experimental: Guatemala: PROCOMIDA<br> | Other: Procomida (Guatemala)<br>* Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices<br>|
| Experimental: Guatemala: no family ration<br> | Other: Procomida (Guatemala)<br>* Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices<br>|
| Experimental: Guatemala: LNS<br> | Other: Procomida (Guatemala)<br>* Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices<br>|
| Experimental: Guatemala: Sprinkles<br> | Other: Procomida (Guatemala)<br>* Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices<br>|
| Experimental: Guatemala: reduced family ration<br> | Other: Procomida (Guatemala)<br>* Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices<br>|
| No Intervention: Guatemala: control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| child nutritional status |  | Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| household food security |  | Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo | 
| household food and non-food consumption |  | Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo | 
| maternal knowledge on infant and young child feeding (IYCF) and health |  | Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo | 
| attitudes towards IYCF and health |  | Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo | 
| morbidity |  | Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo | 
| health care seeking behavior |  | Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition;, Infant nutrition;, Fortified food, Linear growth, Cluster randomized controlled trials, Effectiveness, Impact evaluation studies, Burundi, Guatemala