Clinical trial NCT01072279: Preventing Malnutrition in Children Under Two Years of Age Approach
Official title: Strengthening and Evaluating the "Preventing Malnutrition in Children Under Two Years of Age Approach" (PM2A) in Guatemala and Burundi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Malnutrition;
Infant nutrition;
Fortified food
Linear growth
Cluster randomized controlled trials
Effectiveness
Impact evaluation studies
Burundi
Guatemala
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
Collaborators: name: Food and Nutrition Technical Assistance Project 2 of the Academy of Educational Development
name: United States Agency for International Development (USAID)
name: Catholic Relieve Services-Burundi
name: Mercy Corps-Guatemala
First posted: 2010-02-22
Enrollment: 16895
Sex: ALL
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: child nutritional status
timeFrame: Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
Secondary outcomes:
measure: household food security
timeFrame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
measure: household food and non-food consumption
timeFrame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
measure: maternal knowledge on infant and young child feeding (IYCF) and health
timeFrame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
measure: attitudes towards IYCF and health
timeFrame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
measure: morbidity
timeFrame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
measure: health care seeking behavior
timeFrame: Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo
Other outcomes:
Locations:
city: Bujumbura
country: Burundi
facility: CRS Burundi
city: Guatemala: Coban
country: Guatemala
facility: Guatemala: Mercy Corps
Study officials:
affiliation: IFPRI
name: Marie Ruel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loechl CU, Menon P, Arimond M, Ruel MT, Pelto G, Habicht JP, Michaud L. Using programme theory to assess the feasibility of delivering micronutrient Sprinkles through a food-assisted maternal and child health and nutrition programme in rural Haiti. Matern Child Nutr. 2009 Jan;5(1):33-48. doi: 10.1111/j.1740-8709.2008.00154.x.
citation: Menon P, Mbuya M, Habicht JP, Pelto G, Loechl CU, Ruel MT. Assessing supervisory and motivational factors in the context of a program evaluation in rural Haiti. J Nutr. 2008 Mar;138(3):634-7. doi: 10.1093/jn/138.3.634.
citation: Ruel MT, Menon P, Habicht JP, Loechl C, Bergeron G, Pelto G, Arimond M, Maluccio J, Michaud L, Hankebo B. Age-based preventive targeting of food assistance and behaviour change and communication for reduction of childhood undernutrition in Haiti: a cluster randomised trial. Lancet. 2008 Feb 16;371(9612):588-95. doi: 10.1016/S0140-6736(08)60271-8.
citation: Menon P, Ruel MT, Loechl CU, Arimond M, Habicht JP, Pelto G, Michaud L. Micronutrient Sprinkles reduce anemia among 9- to 24-mo-old children when delivered through an integrated health and nutrition program in rural Haiti. J Nutr. 2007 Apr;137(4):1023-30. doi: 10.1093/jn/137.4.1023.
citation: Menon P, Ruel MT, Loechl C, Pelto G. From research to program design: use of formative research in Haiti to develop a behavior change communication program to prevent malnutrition. Food Nutr Bull. 2005 Jun;26(2):241-2. doi: 10.1177/156482650502600210. No abstract available.
citation: Ruel MT, Menon P, Loechl C, Pelto G. Donated fortified cereal blends improve the nutrient density of traditional complementary foods in Haiti, but iron and zinc gaps remain for infants. Food Nutr Bull. 2004 Dec;25(4):361-76. doi: 10.1177/156482650402500406.
citation: Leroy JL, K Olney D, Bliznashka L, Ruel M. Tubaramure, a Food-Assisted Maternal and Child Health and Nutrition Program in Burundi, Increased Household Food Security and Energy and Micronutrient Consumption, and Maternal and Child Dietary Diversity: A Cluster-Randomized Controlled Trial. J Nutr. 2020 Apr 1;150(4):945-957. doi: 10.1093/jn/nxz295.
citation: Leroy JL, Olney DK, Ruel MT. PROCOMIDA, a Food-Assisted Maternal and Child Health and Nutrition Program, Contributes to Postpartum Weight Retention in Guatemala: A Cluster-Randomized Controlled Intervention Trial. J Nutr. 2019 Dec 1;149(12):2219-2227. doi: 10.1093/jn/nxz175.
citation: Olney DK, Leroy JL, Bliznashka L, Ruel MT. A Multisectoral Food-Assisted Maternal and Child Health and Nutrition Program Targeted to Women and Children in the First 1000 Days Increases Attainment of Language and Motor Milestones among Young Burundian Children. J Nutr. 2019 Oct 1;149(10):1833-1842. doi: 10.1093/jn/nxz133.
citation: Olney DK, Leroy J, Bliznashka L, Ruel MT. PROCOMIDA, a Food-Assisted Maternal and Child Health and Nutrition Program, Reduces Child Stunting in Guatemala: A Cluster-Randomized Controlled Intervention Trial. J Nutr. 2018 Sep 1;148(9):1493-1505. doi: 10.1093/jn/nxy138.
citation: Leroy JL, Olney D, Ruel M. Tubaramure, a Food-Assisted Integrated Health and Nutrition Program, Reduces Child Stunting in Burundi: A Cluster-Randomized Controlled Intervention Trial. J Nutr. 2018 Mar 1;148(3):445-452. doi: 10.1093/jn/nxx063.
citation: Leroy JL, Olney D, Ruel M. Tubaramure, a Food-Assisted Integrated Health and Nutrition Program in Burundi, Increases Maternal and Child Hemoglobin Concentrations and Reduces Anemia: A Theory-Based Cluster-Randomized Controlled Intervention Trial. J Nutr. 2016 Aug;146(8):1601-8. doi: 10.3945/jn.115.227462. Epub 2016 Jul 13.