Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03341338 - Genes-in-Action - Hepcidin Regulation of Iron Supplementation
Completed NCT00060398 - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer Phase 3
Recruiting NCT05384691 - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions Phase 2
Not yet recruiting NCT06309641 - Methemoglobinemia Following Intravenous Iron Treatment
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Completed NCT02930850 - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation N/A
Completed NCT02912494 - A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02912533 - A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT03822884 - Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers Phase 1
Completed NCT02603250 - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda N/A
Completed NCT02384122 - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias Phase 3
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Withdrawn NCT01934842 - A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate N/A
Completed NCT01922479 - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure Phase 4
Completed NCT02310113 - Transfusion and Skeletal Muscle Tissue Oxygenation N/A
Completed NCT01693029 - Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa Phase 3
Terminated NCT01535781 - Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced? N/A
Completed NCT01432717 - Study of ACE-536 in Healthy Postmenopausal Women Phase 1