Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau

Effectiveness of Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Undernutrition
• Intervention / Treatment: Other: Canned Herring

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• There are no eligibility exclusions for this study.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Herring; 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; 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).
No Intervention: Delayed Herring (Control); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in weight-for-age Z-score	baseline, 8-10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
height-for-age Z-score		baseline, 8-10 weeks
mid upper arm circumference (MUAC) measurement	measurement of circumference of the mid upper arm	baseline, 8-10 weeks
weight		baseline, 8-10 weeks
height		baseline, 8-10 weeks

Collaborators and Investigators

• Sponsor: Global Food & Nutrition Inc.
• Collaborators: International Partnership for Human Development; Alaska Seafood Marketing Institute
• Investigators: Principal Investigator: Nina Schlossman, Global Food & Nutrition Inc.; Principal Investigator: Adrian Balan, International Partnership for Human Development

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Estimate): February 11, 2016
• Last Update Submitted That Met QC Criteria: February 10, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: malnutrition; Guinea-Bissau; undernutrition; Z-score; food aid
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: GFN GB 2015