Distribution of Fortified Yoghurt in Senegal to Decrease Children's Anemia and Improve Milk Supply
Primary Purpose
Anemia, Iron-Deficiency
Status
Completed
Phase
Early Phase 1
Locations
Senegal
Study Type
Interventional
Intervention
Micronutrient-fortified yoghurt
BCC
Sponsored by
About this trial
This is an interventional prevention trial for Anemia focused on measuring anemia, children, iron-fortified product, value chain
Eligibility Criteria
Inclusion Criteria:
- All household that supplies milk to the milk factory and accept to enter in the study
- Household with at least one child aged 24 to 59 months old
Exclusion Criteria:
- Household with no children between 24 to 59 months old
Sites / Locations
- IFPRI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Micronutrient-fortified yoghurt
Control
Arm Description
Micronutrient-fortified yoghurt + BCC All eligible children within the intervention arm will receive one fortified yoghurt per day, every day of the week, if the household satisfied to the contract of reliability in milk supply during the previous week, during the one year duration of the intervention.
BCC Children will not receive fortified yoghurt during the duration of the intervention
Outcomes
Primary Outcome Measures
Prevalence of anemia in children 24-59 months after receiving iron fortified yoghurt during a one year intervention
The main outcome is the prevalence of anemia (hemoglobin below 11g/dl). Hemoglobin is measured in all children aged 24-59 months (by Hemocue analyzer) after a one year intervention at endline, in January 2014.
Secondary Outcome Measures
Frequency of milk supply by pastoralist during one year intervention
Frequency of milk supply by pastoralist that deliver milk to the milk factory during the one year intervention
Full Information
NCT ID
NCT02079961
First Posted
May 21, 2013
Last Updated
March 5, 2014
Sponsor
Agnes LePort
Collaborators
GRET, Cellule de Lutte contre la Malnutrition, Universite Gaston Berger
1. Study Identification
Unique Protocol Identification Number
NCT02079961
Brief Title
Distribution of Fortified Yoghurt in Senegal to Decrease Children's Anemia and Improve Milk Supply
Official Title
Better Nutrition Through Agricultural Contracts; Better Contracts Through Nutrition Incentives: A Case Study of Utilizing a Dairy Value Chain in Northern Senegal to Reduce Anemia and Improve Milk Supply
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Agnes LePort
Collaborators
GRET, Cellule de Lutte contre la Malnutrition, Universite Gaston Berger
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study on dairy value chains that will be conducted in Northern Senegal tests whether a health-related product (micro-fortified yogurt) targeted to children can be provided through the logistics of an existing value chain, and whether in return this can be leveraged to enhance the reliability of producers supply within this value chain. This study is conducted with a local milk factory, a recently established social enterprise, striving to produce dairy products with the milk collected from several hundred semi-nomadic small-scale producers in northern Senegal. This study tests: (i) whether the logistic created to collect milk in a remote area can be leveraged to deliver fortified yogurts to infants within its suppliers households; (ii) whether such products effectively help improve the nutritional status (anemia) of these children; and (iii) whether these health services encourage suppliers (and in particular women) to increase their milk delivery to the milk factory.
Detailed Description
Overall Objective
The overall study objectives are to better understand how a value chain can be made to be nutrition sensitive and ultimately leveraged to improve child nutrition, and to understand how certain incentives and services can be offered to actors within the value chain to enhance contractual relationships that strengthen the value chain.
In rural areas of developing countries where health products and services are poorly available, well organized agricultural value chains may be used to enhance access to such products and services to smallholder farmers. Yet, value chains in such countries face important challenges when it comes to enforcing contractual relationships, unless incentive-compatible schemes can be designed. As elsewhere, it may however be that health-related services themselves can, under certain conditions, serve as an adequate incentive towards more sustainable contractual relationships in the value chain.
Specific Objectives This study will address 2 key objectives.
To test whether an incentive in the form of a daily micronutrient-fortified yogurt for children can be used to increase milk supply during dry season and enhance contractual relationship between suppliers and agro-processors
To test whether the dairy value chain can be used as an efficient and sustainable means to supply essential micronutrients to young children, improve the quality of their diet and reduce anemia among young children during the one year duration of the intervention.
The study will focus on the particular case of a dairy value chain in Senegal, and will assess the extent to which micronutrient fortified yogurts can be used as a means to reduce the prevalence of anemia among infants and young children, and reinforce contractual arrangements between milk suppliers and a recently established social enterprise, the local milk factory.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron-Deficiency
Keywords
anemia, children, iron-fortified product, value chain
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
471 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Micronutrient-fortified yoghurt
Arm Type
Experimental
Arm Description
Micronutrient-fortified yoghurt + BCC
All eligible children within the intervention arm will receive one fortified yoghurt per day, every day of the week, if the household satisfied to the contract of reliability in milk supply during the previous week, during the one year duration of the intervention.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
BCC
Children will not receive fortified yoghurt during the duration of the intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Micronutrient-fortified yoghurt
Intervention Description
A iron-fortified yogurt targeted to children 24-59 months old will be provided through the logistics of an existing value chain, to see if in return this can enhance the reliability of producers supply within this value chain.
Intervention Type
Behavioral
Intervention Name(s)
BCC
Intervention Description
Behavior Change Campaign (BCC)
A behavior change campaign will be conducted during all the duration of the intervention to increase knowledge about good infant feeding practices and health.
Primary Outcome Measure Information:
Title
Prevalence of anemia in children 24-59 months after receiving iron fortified yoghurt during a one year intervention
Description
The main outcome is the prevalence of anemia (hemoglobin below 11g/dl). Hemoglobin is measured in all children aged 24-59 months (by Hemocue analyzer) after a one year intervention at endline, in January 2014.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Frequency of milk supply by pastoralist during one year intervention
Description
Frequency of milk supply by pastoralist that deliver milk to the milk factory during the one year intervention
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All household that supplies milk to the milk factory and accept to enter in the study
Household with at least one child aged 24 to 59 months old
Exclusion Criteria:
Household with no children between 24 to 59 months old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rahul Rawat, PhD
Organizational Affiliation
IFPRI
Official's Role
Principal Investigator
Facility Information:
Facility Name
IFPRI
City
Dakar
Country
Senegal
12. IPD Sharing Statement
Citations:
PubMed Identifier
28245227
Citation
Le Port A, Bernard T, Hidrobo M, Birba O, Rawat R, Ruel MT. Delivery of iron-fortified yoghurt, through a dairy value chain program, increases hemoglobin concentration among children 24 to 59 months old in Northern Senegal: A cluster-randomized control trial. PLoS One. 2017 Feb 28;12(2):e0172198. doi: 10.1371/journal.pone.0172198. eCollection 2017.
Results Reference
derived
Learn more about this trial
Distribution of Fortified Yoghurt in Senegal to Decrease Children's Anemia and Improve Milk Supply
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