Preventing Malnutrition in Children Under Two Years of Age Approach

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072279
• Other study ID #: 4001-IFPRI-00
• Status: Completed
• Phase: N/A
• First received: February 17, 2010
• Last updated: February 23, 2016
• Start date: April 2010
• Est. completion date: June 2015

Study information

• Verified date: January 2013
• Source: International Food Policy Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Burundi: Ministry of HealthGuatemala: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16895
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 42 Months

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition

Intervention

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
• 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

Locations

Country	Name	City	State
Burundi	CRS Burundi	Bujumbura
Guatemala	Guatemala: Mercy Corps	Guatemala: Coban

Sponsors (5)

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

Countries where clinical trial is conducted

Burundi,  Guatemala, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	child nutritional status		Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo	No
Secondary	household food security		Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	morbidity		Burundi: after 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo	No
Secondary	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	No