Preventing Malnutrition in Children Under Two Years of Age Approach
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Malnutrition |
Other: Tubaramure (Burundi) Other: Procomida (Guatemala) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Strengthening and Evaluating the "Preventing Malnutrition in Children Under Two Years of Age Approach" (PM2A) in Guatemala and Burundi |
- child nutritional status [ Time Frame: Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ] [ Designated as safety issue: No ]
- household food security [ Time Frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ] [ Designated as safety issue: No ]
- household food and non-food consumption [ Time Frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ] [ Designated as safety issue: No ]
- maternal knowledge on infant and young child feeding (IYCF) and health [ Time Frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ] [ Designated as safety issue: No ]
- attitudes towards IYCF and health [ Time Frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ] [ Designated as safety issue: No ]
- morbidity [ Time Frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ] [ Designated as safety issue: No ]
- health care seeking behavior [ Time Frame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 9184 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Burundi: T24 |
Other: Tubaramure (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
|
| Experimental: Burundi: TNFP |
Other: Tubaramure (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
|
| Experimental: Burundi: T18 |
Other: Tubaramure (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
|
| No Intervention: Burundi: Control | |
| Experimental: Guatemala: PROCOMIDA |
Other: Procomida (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
|
| Experimental: Guatemala: no family ration |
Other: Procomida (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
|
| Experimental: Guatemala: LNS |
Other: Procomida (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
|
| Experimental: Guatemala: Sprinkles |
Other: Procomida (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
|
| Experimental: Guatemala: reduced family ration |
Other: Procomida (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
|
| No Intervention: Guatemala: control |
Eligibility| Ages Eligible for Study: | up to 42 Months |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Jef L Leroy, PhD | j.leroy@cgiar.org | |
| Contact: Deanna Olney, PhD | d.olney@cgiar.org |
| Burundi | |
| CRS Burundi | Recruiting |
| Bujumbura, Burundi | |
| Principal Investigator: Avril Armstrong, PhD | |
| Guatemala | |
| Guatemala: Mercy Corps | Not yet recruiting |
| Guatemala: Coban, Guatemala | |
| Principal Investigator: Susan Richter, PhD | |
| Principal Investigator: | Marie Ruel, PhD | IFPRI |
More Information
Publications:
| Responsible Party: | International Food Policy Research Institute |
| ClinicalTrials.gov Identifier: | NCT01072279 History of Changes |
| Other Study ID Numbers: | 4001-IFPRI-00 |
| Study First Received: | February 17, 2010 |
| Last Updated: | January 1, 2013 |
| Health Authority: | Burundi: Ministry of Health Guatemala: Ministry of Health |
Keywords provided by International Food Policy Research Institute:
|
Malnutrition; Infant nutrition; Fortified food Linear growth Cluster randomized controlled trials |
Effectiveness Impact evaluation studies Burundi Guatemala |
Additional relevant MeSH terms:
|
Malnutrition Child Nutrition Disorders Nutrition Disorders |
ClinicalTrials.gov processed this record on May 19, 2013