Skip to content

Preventing Malnutrition in Children Under Two Years of Age Approach

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01072279
Enrollment
16895
Registered
2010-02-22
Start date
2010-04-30
Completion date
2015-06-30
Last updated
2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

Malnutrition;, Infant nutrition;, Fortified food, Linear growth, Cluster randomized controlled trials, Effectiveness, Impact evaluation studies, Burundi, Guatemala

Brief summary

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.

Interventions

OTHERTubaramure (Burundi)

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

OTHERProcomida (Guatemala)

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

Sponsors

Food and Nutrition Technical Assistance Project 2 of the Academy of Educational Development
CollaboratorUNKNOWN
United States Agency for International Development (USAID)
CollaboratorFED
Catholic Relieve Services-Burundi
CollaboratorUNKNOWN
Mercy Corps-Guatemala
CollaboratorUNKNOWN
International Food Policy Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 42 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
child nutritional statusBurundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo

Secondary

MeasureTime frame
household food and non-food consumptionBurundi: 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 healthBurundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
household food securityBurundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
morbidityBurundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
health care seeking behaviorBurundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
attitudes towards IYCF and healthBurundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo

Countries

Burundi, Guatemala

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026