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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01825226
Other study ID # 6117001
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 1, 2013
Last updated September 15, 2016
Start date February 2010
Est. completion date September 2017

Study information

Verified date September 2016
Source International Food Policy Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardBurkina Faso: Ethical committee for research in health
Study type Interventional

Clinical Trial Summary

Helen Keller International (HKI) has been implementing homestead food production (HFP) programs in Asia for the past 20 years and has recently begun implementing HFP programs in Africa as well. In general, these programs target women and are designed to improve maternal and child health and nutrition outcomes through three primary pathways: 1. Increasing the availability of micronutrient-rich foods through increased household production of these foods; 2. Raising income through the sale of surplus production; and 3. Increasing knowledge and adoption of optimal nutrition practices, including the consumption of micronutrient-rich foods. Evaluations of HFP programs have consistently demonstrated significant increases in household production and consumption of micronutrient-rich foods. This increased consumption, along with improvements in health and nutrition related knowledge, and increased income, could all contribute to improvements in maternal and child health and nutrition outcomes. However, to date there has been limited understanding as to how these types of programs can be optimized to maximize impacts on these outcomes.

In order to better understand the potential of these types of programs to improve maternal and child health and nutrition outcomes and how this impact may be achieved IFPRI has been collaborating with HKI to evaluate one of their E-HFP programs in Burkina Faso. The evaluation considers impact of the program through the three pathways above, and assesses anthropometric and clinical measures of nutrition, as well as looking at how the programs might be improved.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1763
Est. completion date September 2017
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 12 Months
Eligibility Inclusion Criteria:

- Mother of child between the ages of 3 and 12 months and her child

Exclusion Criteria:

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Enhanced-Homestead Food Production Program
Participation in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication

Locations

Country Name City State
United States International Food Policy Research Institute Washington District of Columbia

Sponsors (3)

Lead Sponsor Collaborator
International Food Policy Research Institute Bill and Melinda Gates Foundation, United States Agency for International Development (USAID)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Growth Change in height-for-age Z-scores, weight-for-age Z-scores and weight-for-height Z-scores will be measured as well as the change in the prevalence of stunting (HAZ <-2), underweight (WAZ <-2) and wasting (WHZ <-2) over the course of the two year program period. Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months No
Primary Hemoglobin Measurements will be made for children between the ages of 3 and 12 months of age at baseline and then 2 years later, at endline, when the children are between the ages of 23 and 40 months No
Secondary Food security Baseline (2010), Endline (2012), follow-up (2013) No
Secondary Household assets Baseline (2010), Endline (2012), follow-up (2013) No
Secondary Household consumption Baseline (2010), Endline (2012), follow-up (2013) No
Secondary Household livestock holdings Baseline (2010), Endline (2012), follow-up (2013) Yes
Secondary Dietary diversity Baseline (2010), Endline (2012), follow-up (2013) No
Secondary Mother's BMI Baseline (2010), Endline (2012), follow-up (2013) No
Secondary Maternal health and nutrition-related knowledge Baseline (2010), Endline (2012), follow-up (2013) No
Secondary IYCF practices Baseline (2010), Endline (2012), follow-up (2013) No
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