Action Against Malnutrition Through Agriculture (AAMA) Plus MNP Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Helen Keller International.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
Pooja Pandey Rana, Helen Keller International
ClinicalTrials.gov Identifier:
NCT01488305
First received: December 5, 2011
Last updated: December 7, 2011
Last verified: December 2011

December 5, 2011
December 7, 2011
October 2010
February 2012   (final data collection date for primary outcome measure)
Anemia [ Time Frame: One year ] [ Designated as safety issue: Yes ]
All three arms anemia status will be compared after one year of MNP distribution (assess the additional value of MNP)
Same as current
Complete list of historical versions of study NCT01488305 on ClinicalTrials.gov Archive Site
Impact on growth of children [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Assess the growth of children (wasting, underweigh and stunting)after one year of MNP distribution (MNP distribution started in March 2011)
Same as current
Not Provided
Not Provided
 
Action Against Malnutrition Through Agriculture (AAMA) Plus MNP Study
Impact of Micronutrient Powders (MNP)With Homestead Food Production and an Intensive Community Level IYCF-BCC Intervention on Reducing Anemia and Improving Growth in Young Children, Nepal

Helen Keller International (HKI), the ministry of health and population, and ministry of agriculture and cooperatives, of Nepal and local non-governmental organizations (NGO) partners are currently implementing a USAID funded Action Against Malnutrition Through Agriculture (AAMA) project in Baitadi district located in far Western development region of Nepal. HKI is undertaking this study within the AAMA project to test whether providing micro-nutrient powders (MNPs) in a programmatic context along with homestead food production (HFP) and an intensive community level Infant and Young Child Feeding Behavior change communication (IYCF-BCC) intervention will have a greater impact on reducing anemia and improving growth in young children than only providing the HFP and IYCF-BCC intervention without MNPs or a control with no intervention.

The AAMA project uses the homestead food production (HFP) model that focuses on increasing households year round access to nutritious food as a platform to deliver a proven essential nutrition actions (ENA) related messages to household with children less than 2 years old. The AAMA project seeks to examine the effects of household level HFP on malnutrition. So the recipient and other partners wishes to undertake a study to explore a plausible delivery mechanism for MNPs along with HFP and intensive community level IYCF-BCC and their impact on infant/child growth and anemia.

The study is a cluster randomized controlled trial with a three arm factorial design. The trial involve 330 randomly selected children aged 6-9 months at the time of enrollment (n=110 per each of the three study arms). MNPs distributed through FCHVs to 110 children selected from communities that already have the HFP and IYCF-BCC intervention. This group of children will be compared on outcome parameters for anemia, growth (stunting, underweight and wasting) and infections (diarrhea, fever and cough) to a similar sub-set of children (n=110) who receive only the HFP and IYCF-BCC intervention and to a third sub-set of control children of similar age (n=110) who are not receiving either of these interventions. Children aged 6-9 months were chosen for the study because this age range captures the recommended age for introduction of complementary foods to children and our chosen age group also falls within the 0-24 month age range which is considered the period of rapid growth and development and therefore period of highest nutrient requirements in children.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Anemia
Dietary Supplement: MNP (micro-nutrient powders)
MNP is added to explore the additional value of MNP in existing AAMA program
Other Name: MNP sub study in AAMA
  • No Intervention: Only government regular program
    One arm is control arm, in this arm no additional program is added in government regular program
  • No Intervention: AAMA arm (HFP and IYCF BCC)
    Second arm is AAMA project intervention which includes HFP activities, ENA and BCC activities
  • No Intervention: MNP added in AAMA
    It is actually a intervention arm
    Intervention: Dietary Supplement: MNP (micro-nutrient powders)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
334
March 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children 6-9 months of age during enrollment time
  • Mothers who want to enroll their children in study

Exclusion Criteria:

  • Severe anemia
  • Children age below six months and age over 23 months during study time
Both
6 Months to 23 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Nepal
 
NCT01488305
09-000076- AT, MNP impact study
Yes
Pooja Pandey Rana, Helen Keller International
Helen Keller International
University of California, Davis
Principal Investigator: Pooja Pandey Rana, MPH Helen Keller International
Helen Keller International
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP