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

Not Applicable

Completed

• Conditions: Undernutrition; Malnutrition
• Interventions: Other: Canned Herring

• Registration Number: NCT02496247
• Lead Sponsor: Global Food & Nutrition Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-30
• Study Start: 2015-05
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-14
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Herring	Canned 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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in weight-for-age Z-score	baseline, 8-10 weeks

Secondary Outcome Measures

Name	Time	Method
weight	baseline, 8-10 weeks
height	baseline, 8-10 weeks
mid upper arm circumference (MUAC) measurement	baseline, 8-10 weeks	measurement of circumference of the mid upper arm
height-for-age Z-score	baseline, 8-10 weeks