NCT02496247

Brief Summary

This study will test the effectiveness of a weekly village distribution of canned herring for prevention of malnutrition in children aged 2-5 years old during a food-insecure time of the year in rural villages in Guinea-Bissau. The study will use community health workers to conduct the herring distribution, making this a test that will provide valuable information on what could become a practical food aid supplementation practice. The primary study hypothesis is that distribution of canned herring as a weekly food supplement to families with young children at the beginning of the rainy season will prevent a seasonal decrease in weight-for-age Z-score (primary variable) of children with mild to moderate malnutrition at baseline.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

April 30, 2015

Last Update Submit

February 10, 2016

Conditions

Keywords

malnutritionundernutritionZ-scoreGuinea-Bissaufood aid

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in weight-for-age Z-score

    baseline, 8-10 weeks

Secondary Outcomes (4)

  • height-for-age Z-score

    baseline, 8-10 weeks

  • mid upper arm circumference (MUAC) measurement

    baseline, 8-10 weeks

  • weight

    baseline, 8-10 weeks

  • height

    baseline, 8-10 weeks

Study Arms (2)

Immediate Herring

EXPERIMENTAL

Participants in this arm will receive the Canned Herring intervention. Families with children in this study arm will receive a weekly ration of herring throughout the 8-10 week study period (2 cans herring/day per study child), which will be distributed weekly by community health workers. Families will be instructed to feed the study child half a can of herring per day (without reducing usual home food given to the child), and to not share the remaining herring with individuals who are in the Delayed Herring study arm. When families come to collect their weekly distribution they will be asked to bring in at least 7 empty herring cans in order to receive the next ration, and will answer a question about how often the child eats the herring.

Other: Canned Herring

Delayed Herring (Control)

NO INTERVENTION

Families with children in this study arm will not receive any herring during the 8-10 week period when Immediate Herring families receive a weekly ration of herring. After the 8-10 week (end line) measurements, an equal amount of herring will be distributed to the family.

Interventions

Families with children in this study arm will receive a weekly ration of herring throughout the 8-10 week study period (2 cans herring/day per study child).

Immediate Herring

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Village leaders willing to allow the study to take place in their village
  • Village must have community health workers who are willing to do the weekly distribution of herring to enrolled families and are able to keep the necessary records documenting the distribution.
  • Children age 2-5 currently living in a selected village
  • Parents willing to participate in the study

You may not qualify if:

  • If a child is identified with severe malnutrition at the baseline measurement, the family will be advised to take the child for treatment rather than participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Nina Schlossman

    Global Food & Nutrition Inc.

    PRINCIPAL INVESTIGATOR
  • Adrian Balan

    International Partnership for Human Development

    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

April 30, 2015

First Posted

July 14, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 11, 2016

Record last verified: 2016-02