Back to resultsCanned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau
Primary Purpose
Malnutrition, Undernutrition
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Canned Herring
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition focused on measuring malnutrition, undernutrition, Z-score, Guinea-Bissau, food aid
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Immediate Herring
Delayed Herring (Control)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from Baseline in weight-for-age Z-score
Secondary Outcome Measures
height-for-age Z-score
mid upper arm circumference (MUAC) measurement
measurement of circumference of the mid upper arm
weight
height
Full Information
NCT ID
NCT02496247
First Posted
April 30, 2015
Last Updated
February 10, 2016
Sponsor
Global Food & Nutrition Inc.
Collaborators
Alaska Seafood Marketing Institute, International Partnership for Human Development
1. Study Identification
Unique Protocol Identification Number
NCT02496247
Brief Title
Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau
Official Title
Effectiveness of Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Global Food & Nutrition Inc.
Collaborators
Alaska Seafood Marketing Institute, International Partnership for Human Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Undernutrition
Keywords
malnutrition, undernutrition, Z-score, Guinea-Bissau, food aid
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Herring
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Herring (Control)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Canned Herring
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from Baseline in weight-for-age Z-score
Time Frame
baseline, 8-10 weeks
Secondary Outcome Measure Information:
Title
height-for-age Z-score
Time Frame
baseline, 8-10 weeks
Title
mid upper arm circumference (MUAC) measurement
Description
measurement of circumference of the mid upper arm
Time Frame
baseline, 8-10 weeks
Title
weight
Time Frame
baseline, 8-10 weeks
Title
height
Time Frame
baseline, 8-10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Schlossman
Organizational Affiliation
Global Food & Nutrition Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adrian Balan
Organizational Affiliation
International Partnership for Human Development
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau
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