NCT02259166

Brief Summary

The purpose of this study is to assess if the Enhanced Homestead Food Production Plus (EHFP+) Program implemented by HKI in Mwanza, Tanzania, enhances uptake of Micronutrient Powder (MNP) supplementation in children, helps maintaining reduced anemia levels among children after a blanket provision of MNP, and has an impact on child growth, infant and young child feeding (IYCF) practices, maternal knowledge related to health, nutrition, WASH and malaria prevention, food security and women's empowerment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,325

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

September 5, 2014

Last Update Submit

September 16, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anemia (g/dl and %)

    Change in prevalence of anemia and hemoglobin concentration will be measured over the course of the program period.(at baseline, during follow-up after 3, 6 and 12 months and after 18 months at endline)

    Measurements will be made for children aged 6 to 11 months at baseline and up to 3 months, 6 months, 12 months and 18 months (at endline), when the children are between the ages of 24 and 30 months

Secondary Outcomes (7)

  • Growth (Z-score and %)

    Measurements will be made for children between the ages of 6 and 11 months of age at baseline and 18 months later, at endline, when the children are between the ages of 24 and 30 months

  • Biochemical markers

    Baseline (June 2014), Follow-up1 (up to 3 months) and after 18 months at Endline

  • Dietary diversity (%)

    Baseline (2014) and after 18 months at Endline

  • Food security (%)

    Baseline (2014) and after 18 months at Endline (2016)

  • Women's empowerment (%)

    Baseline (2014) and after 18 months at Endline (2016)

  • +2 more secondary outcomes

Study Arms (2)

EHFP+

EXPERIMENTAL

Group receiving the intervention EHFP+, in addition to MNPs distribution for 2 months and malaria diagnosis and treatment for children enrolled, at baseline and after 12 months

Other: EHFP+

Control

NO INTERVENTION

MNPs distribution for 2 months and malaria diagnosis and treatment for children enrolled, at baseline and after 12 months

Interventions

EHFP+OTHER

Enhanced-homestead food production program including home gardening and poultry rearing + WASH interventions + SBCC around the essential nutrition actions and WASH/malaria prevention with a gender component.

EHFP+

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • women living in the study area
  • having one child aged 6-12 months of age

You may not qualify if:

  • children with severe anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Medical Research

Mwanza, Tanzania

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Rahul Rawat, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR
  • Erin Smith

    Helen Keller International

    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 5, 2014

First Posted

October 8, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 19, 2016

Record last verified: 2015-09

Data Sharing

IPD Sharing
Will not share

Locations