NCT02516852

Brief Summary

Animal source foods (ASF), such as meat and eggs, are rich in nutrients critical for growth and development. Yet, for poor children in developing countries, ASF consumption is limited by cost, inadequate caregiver knowledge, and lack of local production and physical availability. The impact of HH- and village-level livestock interventions on household dietary diversity and nutritional status in resource-poor communities is not well established. The objective of this study is to test the effectiveness of local egg production intervention on maternal and child diets and child nutrition status. This project takes place in the Luangwa Valley, Zambia in partnership with a local non-governmental organization, COMACO. Twenty communities will be assigned to the intervention, and 20 matched communities will be selected as controls. In each intervention community, an egg production facility will be built, owned, and operated by trained COMACO farmers. Households (HHs) in each community will be sampled twice annually for 1 year pre-intervention (baseline) and 1 year post-intervention to assess dietary diversity and nutritional status. Data analysis will test for a change in these outcomes from baseline in each intervention community compared to the matched control community.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,546

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 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

June 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

August 3, 2015

Last Update Submit

February 2, 2018

Conditions

Malnutrition, ChildMalnutrition, Infant

Keywords

community development; poultry; animal-source food; stunting

Outcome Measures

Primary Outcomes (1)

  • Change in child height-for-age Z-score

    Recumbent length for children \< 24 months and standing height for those 24-36 months, with WHO Child Growth Standards as the reference population.

    6, 12, 18, and 24 months after intervention

Secondary Outcomes (6)

  • Change in household egg consumption

    6, 12, 18, and 24 months after intervention

  • Change in maternal egg consumption

    6, 12, 18, and 24 months after intervention

  • Change in child egg consumption

    6, 12, 18, and 24 months after intervention

  • Change in maternal dietary diversity

    6, 12, 18, and 24 months after intervention

  • Change in child dietary diversity

    6, 12, 18, and 24 months after intervention

  • +1 more secondary outcomes

Other Outcomes (6)

  • Change in household food security

    6, 12, 18, and 24 months after intervention

  • Change in producer household and poultry incomes

    6, 12, 18, and 24 months after intervention

  • Change in maternal physical and emotional health

    6, 12, 18, and 24 months after intervention

  • +3 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Egg production

Control

NO INTERVENTION

Interventions

Egg productionOTHER

Establishment and support of a community-owned and -operated egg production facility located at a central location in the community

Intervention

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • the HH dwelling is ≤1.5 km from the egg production facility or central control point;
  • there is a child 6-36 months of age in the HH; and,

You may not qualify if:

  • the mother/primary caretaker or head of HH cannot converse with the field staff because of language;
  • the mother/primary caretaker or head of HH is unable to give informed consent or complete an interview without assistance; or,
  • the child is deformed, disabled, severely ill, or unable to cooperate for anthropometric measures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

COMACO

Mfuwe, Eastern Province, Zambia

Location

Related Links

MeSH Terms

Conditions

Child Nutrition DisordersInfant Nutrition DisordersGrowth Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander J Travis, VMD, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 6, 2015

Study Start

June 1, 2014

Primary Completion

July 1, 2016

Study Completion

May 1, 2017

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

ZA(1)