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
  Purpose

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.


Condition Intervention
Anemia
Dietary Supplement: MNP (micro-nutrient powders)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Helen Keller International:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 334
Study Start Date: October 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   6 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488305

Locations
Nepal
Helen Keller International, Nepal
Baitadi, Nepal
Sponsors and Collaborators
Helen Keller International
University of California, Davis
Investigators
Principal Investigator: Pooja Pandey Rana, MPH Helen Keller International
  More Information

Additional Information:
No publications provided

Responsible Party: Pooja Pandey Rana, Programs Director, Helen Keller International
ClinicalTrials.gov Identifier: NCT01488305     History of Changes
Other Study ID Numbers: 09-000076- AT, MNP impact study
Study First Received: December 5, 2011
Last Updated: December 7, 2011
Health Authority: Nepal: Health Research Council

Keywords provided by Helen Keller International:
MNP
AAMA program
Nepal
HFP
IYCF
BCC

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014