NCT02236468

Brief Summary

The purpose of this study is to assess the long-term impact of the Enhanced Homestead Food Production Program implemented by HKI on household food security and nutritional status, as well as the impact on including additional interventions (BCC on WASH and malaria prevention, distribution of preventive lipid-based nutrient supplements (LNS)) to children aged 6-24 months old, in addition to the standard E-HFP model.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,747

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

September 3, 2014

Last Update Submit

September 16, 2016

Conditions

AnemiaGrowth Retardation

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin (g/dl)

    Changes in hemoglobin (g/dl) and in prevalence of anemia (\<11g/dl) will be measured over the course of the two year program period.

    Measurements will be made for children between the ages of 0 and 12 months of age at baseline and 2 years later, at endline, when the children are between the ages of 24 and 36 months.

Secondary Outcomes (7)

  • Dietary diversity (%)

    Baseline (2014) and after 24 months at Endline (2016)

  • Food security (%)

    Baseline (2014) and after 24 months at Endline (2016)

  • Biochemical markers

    Baseline (2014) and after 24 months at Endline (2016)

  • Women's empowerment (%)

    Baseline (2014) and after 24 months at Endline (2016)

  • Maternal health and nutrition/WASH/malaria-related knowledge (%)

    Baseline (2014) and after 24 months at Endline (2016)

  • +2 more secondary outcomes

Study Arms (4)

new EHFP

EXPERIMENTAL

Group newly participating in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014

Other: Enhanced-Homestead Food Production Program (new)

old EHFP+WASH

EXPERIMENTAL

Group participating in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010 + WASH/malaria behavior change communication since 2014

Other: Enhanced-Homestead Food Production Program (old)Behavioral: WASH/malaria behavior change

new EHFP+WASH

OTHER

Group newly participating in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014 + WASH/malaria behavior change communication since 2014

Behavioral: WASH/malaria behavior changeOther: Enhanced-Homestead Food Production Program (new)

old EHFP+WASH+LNS distribution

OTHER

Group participating in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010 + WASH/malaria behavior change communication and distribution of LNS since 2014

Other: Enhanced-Homestead Food Production Program (old)Behavioral: WASH/malaria behavior changeDietary Supplement: LNS distribution

Interventions

Enhanced-Homestead Food Production Program (old)OTHER

Participation in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010

old EHFP+WASHold EHFP+WASH+LNS distribution
WASH/malaria behavior changeBEHAVIORAL

WASH/malaria behavior change communication

new EHFP+WASHold EHFP+WASHold EHFP+WASH+LNS distribution
LNS distributionDIETARY_SUPPLEMENT

Distribution of Nutributter (Fanga Degue) for children

old EHFP+WASH+LNS distribution
Enhanced-Homestead Food Production Program (new)OTHER

Participation in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014

new EHFPnew EHFP+WASH

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Mother of child between the ages of 0 and 12 months and her child

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hellen Keller International

Fada, Gourma, Burkina Faso

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Deanna Olney, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2014

First Posted

September 10, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 19, 2016

Record last verified: 2016-09

Locations

BU(1)