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

NCT ID: NCT02496247

Last Updated: 2016-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-08-31

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.

Conditions

Malnutrition; Undernutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Canned Herring

Intervention Type: OTHER

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).

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alaska Seafood Marketing Institute

UNKNOWN

Sponsor Role: collaborator

International Partnership for Human Development

UNKNOWN

Sponsor Role: collaborator

Global Food & Nutrition Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nina Schlossman

Role: PRINCIPAL_INVESTIGATOR

Global Food & Nutrition Inc.

Adrian Balan

Role: PRINCIPAL_INVESTIGATOR

International Partnership for Human Development

Other Identifiers

GFN GB 2015

Identifier Type: -

Identifier Source: org_study_id