Action Against Malnutrition Through Agriculture (AAMA) Plus MNP Study (MNP)

August 22, 2019 updated by: Helen Keller International

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
      • Baitadi, Nepal
        • Helen Keller International, Nepal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Only government regular program
One arm is control arm, in this arm no additional program is added in government regular program
Experimental: AAMA arm (HFP and IYCF BCC)
Second arm is AAMA project intervention which includes HFP activities, ENA and BCC activities
Other: AAMA project activities (HFP and IYCF BCC)
This is the existing AAMA program
Experimental: MNP added in AAMA
It is actually a intervention arm
Other: AAMA project activities (HFP and IYCF BCC)
This is the existing AAMA program
Dietary supplement: MNP (micro-nutrient powders)
MNP is added to explore the additional value of MNP in existing AAMA program
Other Names:
  • MNP sub study in AAMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anemia
Time Frame: One year
All three arms anemia status will be compared after one year of MNP distribution (assess the additional value of MNP)
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact on growth of children
Time Frame: one year
Assess the growth of children (wasting, underweigh and stunting)after one year of MNP distribution (MNP distribution started in March 2011)
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helen Keller International

Collaborators

University of California, Davis

Investigators

  • Principal Investigator: Pooja Pandey Rana, MPH, Helen Keller International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 5, 2011

First Submitted That Met QC Criteria

December 7, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 22, 2019

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-000076- AT
  • MNP impact study (Other Grant/Funding Number: 09-000076-AT10)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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