Action Against Malnutrition Through Agriculture (AAMA) Plus MNP Study (MNP)
Primary Purpose
Anemia
Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
MNP (micro-nutrient powders)
AAMA project activities (HFP and IYCF BCC)
Sponsored by
About this trial
This is an interventional other trial for Anemia focused on measuring MNP, AAMA program, Nepal, HFP, IYCF, BCC
Eligibility Criteria
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
Sites / Locations
- Helen Keller International, Nepal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Only government regular program
AAMA arm (HFP and IYCF BCC)
MNP added in AAMA
Arm Description
One arm is control arm, in this arm no additional program is added in government regular program
Second arm is AAMA project intervention which includes HFP activities, ENA and BCC activities
It is actually a intervention arm
Outcomes
Primary Outcome Measures
Anemia
All three arms anemia status will be compared after one year of MNP distribution (assess the additional value of MNP)
Secondary Outcome Measures
Impact on growth of children
Assess the growth of children (wasting, underweigh and stunting)after one year of MNP distribution (MNP distribution started in March 2011)
Full Information
NCT ID
NCT01488305
First Posted
December 5, 2011
Last Updated
August 22, 2019
Sponsor
Helen Keller International
Collaborators
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT01488305
Brief Title
Action Against Malnutrition Through Agriculture (AAMA) Plus MNP Study
Acronym
MNP
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helen Keller International
Collaborators
University of California, Davis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
MNP, AAMA program, Nepal, HFP, IYCF, BCC
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Only government regular program
Arm Type
No Intervention
Arm Description
One arm is control arm, in this arm no additional program is added in government regular program
Arm Title
AAMA arm (HFP and IYCF BCC)
Arm Type
Experimental
Arm Description
Second arm is AAMA project intervention which includes HFP activities, ENA and BCC activities
Arm Title
MNP added in AAMA
Arm Type
Experimental
Arm Description
It is actually a intervention arm
Intervention Type
Dietary Supplement
Intervention Name(s)
MNP (micro-nutrient powders)
Other Intervention Name(s)
MNP sub study in AAMA
Intervention Description
MNP is added to explore the additional value of MNP in existing AAMA program
Intervention Type
Other
Intervention Name(s)
AAMA project activities (HFP and IYCF BCC)
Intervention Description
This is the existing AAMA program
Primary Outcome Measure Information:
Title
Anemia
Description
All three arms anemia status will be compared after one year of MNP distribution (assess the additional value of MNP)
Time Frame
One year
Secondary Outcome Measure Information:
Title
Impact on growth of children
Description
Assess the growth of children (wasting, underweigh and stunting)after one year of MNP distribution (MNP distribution started in March 2011)
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pooja Pandey Rana, MPH
Organizational Affiliation
Helen Keller International
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helen Keller International, Nepal
City
Baitadi
Country
Nepal
12. IPD Sharing Statement
Links:
URL
http://www.hki.org
Description
Helen Keller international
Learn more about this trial
Action Against Malnutrition Through Agriculture (AAMA) Plus MNP Study
We'll reach out to this number within 24 hrs