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Translating Adoption of Improved Varieties Into Nutritional Impact (QPM)

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adoption Encouragement Treatment
Consumption Encouragement Treatment
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring Biomarkers, Child Nutrition Sciences, Economics, Behavioral

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Households with at least one child in the 6-35 month age range in August 2015, who had at least one household member attend a field day demonstrating Quality Protein Maize, and who provided informed consent for participation and data collection were eligible for inclusion.

Exclusion Criteria:

Households in the study areas that do not have a member who attends a field day demonstrating Quality Protein Maize or who do not have a child in the appropriate age range are excluded from the study. Furthermore, households where the mother or children did not intend on staying in the region for the study duration (until the completion of the endline survey) were excluded from the study. Finally, we excluded participants who do not have access to land for crop cultivation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control

    Adoption Encouragement Treatment

    Consumption Encouragement Treatment

    Arm Description

    Households in the control group receive no special treatment.

    Households in the Adoption Encouragement Treatment group were visited between March and April 2015 and offered "child nutrition focused" adoption encouragement. Both the male household head and the primary female caregiver were invited to attend these meetings (though the household head is the primary target), where the nutritional benefits of Quality Protein Maize (QPM) adoption for children were emphasized along with the agronomic properties. In addition, the fact that only small amounts of QPM are necessary to nourish children was highlighted and small seed bag sizes were offered. During the adoption encouragement visit, we offered the option to order up to three 2 kg bags of QPM for free.

    In addition to receiving the Adoption Encouragement Treatment, households in the Consumption Encouragement Treatment group received additional information, targeted to the caregiver, and tools for separating Quality Protein Maize and targeting it to young children in the household in August 2015. They will additionally receive further guidance in February 2016.

    Outcomes

    Primary Outcome Measures

    Consumption of any QPM by the index child in the last 24 hours
    Amount of QPM consumed by the index child in the last 24 hours
    Index child's proportion of total maize consumption that was QPM in the last 24 hours
    Consumption of any QPM by the index child in the last week
    Number of days in the last week that the index child ate any QPM
    Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children
    Height-for-age Z-score of index child
    Weight-for-height Z-score of index child
    Weight-for-age Z-score of index child
    Mid-upper arm circumference-for-age Z-score of index child
    Insulin-like growth factor I (continuous measurement)
    Amount of QPM reserved for home consumption
    Hectares of QPM planted
    Serum transthyretin
    Consumption of any QPM by the index child in the last 24 hours
    Amount of QPM consumed by the index child in the last 24 hours
    Index child's proportion of total maize consumption that was QPM in the last 24 hours
    Consumption of any QPM by the index child in the last week
    Number of days in the last week that the index child ate any QPM
    Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children
    Height-for-age Z-score of index child
    Weight-for-height Z-score of index child
    Weight-for-age Z-score of index child
    Mid-upper arm circumference-for-age Z-score of index child
    Amount of QPM reserved for home consumption
    Change in Height-for-age Z-score of index child
    Change in Height-for-age Z-score of index child
    Change in Weight-for-height Z-score of index child
    Change in Weight-for-height Z-score of index child
    Change in Mid-upper arm circumference-for-age Z-score of index child
    Change in Mid-upper arm circumference-for-age Z-score of index child
    Change in Weight-for-age Z-score of index child
    Change in Weight-for-age Z-score of index child

    Secondary Outcome Measures

    Serum lysine
    Serum tryptophan

    Full Information

    First Posted
    February 29, 2016
    Last Updated
    March 8, 2017
    Sponsor
    Harvard School of Public Health (HSPH)
    Collaborators
    CIMMYT International Maize and Wheat Improvement Center, Ethiopian Public Health Institute, Agricultural Technology Adoption Initiative
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02710760
    Brief Title
    Translating Adoption of Improved Varieties Into Nutritional Impact
    Acronym
    QPM
    Official Title
    Translating Adoption of Improved Varieties Into Nutritional Impact for Young Children: An RCT Exploring Strategies to Increase Consumption of Quality Protein Maize in Ethiopia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Harvard School of Public Health (HSPH)
    Collaborators
    CIMMYT International Maize and Wheat Improvement Center, Ethiopian Public Health Institute, Agricultural Technology Adoption Initiative

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purposes of this study are (1) to determine whether child nutrition-focused adoption encouragement messages focused on Quality Protein Maize (QPM) and the availability of small quantities of QPM seed can be effective at increasing QPM adoption and health outcomes for young children, and (2) to determine whether consumption encouragement messages and techniques (e.g., containers for earmarking) can be effective at increasing QPM targeting to and health outcomes for young children.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malnutrition
    Keywords
    Biomarkers, Child Nutrition Sciences, Economics, Behavioral

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    978 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Households in the control group receive no special treatment.
    Arm Title
    Adoption Encouragement Treatment
    Arm Type
    Experimental
    Arm Description
    Households in the Adoption Encouragement Treatment group were visited between March and April 2015 and offered "child nutrition focused" adoption encouragement. Both the male household head and the primary female caregiver were invited to attend these meetings (though the household head is the primary target), where the nutritional benefits of Quality Protein Maize (QPM) adoption for children were emphasized along with the agronomic properties. In addition, the fact that only small amounts of QPM are necessary to nourish children was highlighted and small seed bag sizes were offered. During the adoption encouragement visit, we offered the option to order up to three 2 kg bags of QPM for free.
    Arm Title
    Consumption Encouragement Treatment
    Arm Type
    Experimental
    Arm Description
    In addition to receiving the Adoption Encouragement Treatment, households in the Consumption Encouragement Treatment group received additional information, targeted to the caregiver, and tools for separating Quality Protein Maize and targeting it to young children in the household in August 2015. They will additionally receive further guidance in February 2016.
    Intervention Type
    Other
    Intervention Name(s)
    Adoption Encouragement Treatment
    Intervention Description
    Households in the Adoption Encouragement Treatment received child nutrition focused guidance on the nutritional and agronomic benefits of Quality Protein Maize (QPM) adoption, and the opportunity to order up to 6 kg of QPM seed to plant in their own fields.
    Intervention Type
    Other
    Intervention Name(s)
    Consumption Encouragement Treatment
    Intervention Description
    Households in the Consumption Encouragement Treatment received the same guidance as households in the Adoption Encouragement Treatment, as well as additional guidance on the importance of specifically targeting foods made with QPM to young children and tools to help households keep the grain separate and remember to feed QPM-based foods to the young children.
    Primary Outcome Measure Information:
    Title
    Consumption of any QPM by the index child in the last 24 hours
    Time Frame
    6-7 months
    Title
    Amount of QPM consumed by the index child in the last 24 hours
    Time Frame
    6-7 months
    Title
    Index child's proportion of total maize consumption that was QPM in the last 24 hours
    Time Frame
    6-7 months
    Title
    Consumption of any QPM by the index child in the last week
    Time Frame
    6-7 months
    Title
    Number of days in the last week that the index child ate any QPM
    Time Frame
    6-7 months
    Title
    Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children
    Time Frame
    6-7 months
    Title
    Height-for-age Z-score of index child
    Time Frame
    6-7 months
    Title
    Weight-for-height Z-score of index child
    Time Frame
    6-7 months
    Title
    Weight-for-age Z-score of index child
    Time Frame
    6-7 months
    Title
    Mid-upper arm circumference-for-age Z-score of index child
    Time Frame
    6-7 months
    Title
    Insulin-like growth factor I (continuous measurement)
    Time Frame
    6-7 months
    Title
    Amount of QPM reserved for home consumption
    Time Frame
    6-7 months
    Title
    Hectares of QPM planted
    Time Frame
    6-7 months
    Title
    Serum transthyretin
    Time Frame
    6-7 months
    Title
    Consumption of any QPM by the index child in the last 24 hours
    Time Frame
    10-11 months
    Title
    Amount of QPM consumed by the index child in the last 24 hours
    Time Frame
    10-11 months
    Title
    Index child's proportion of total maize consumption that was QPM in the last 24 hours
    Time Frame
    10-11 months
    Title
    Consumption of any QPM by the index child in the last week
    Time Frame
    10-11 months
    Title
    Number of days in the last week that the index child ate any QPM
    Time Frame
    10-11 months
    Title
    Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children
    Time Frame
    10-11 months
    Title
    Height-for-age Z-score of index child
    Time Frame
    10-11 months
    Title
    Weight-for-height Z-score of index child
    Time Frame
    10-11 months
    Title
    Weight-for-age Z-score of index child
    Time Frame
    10-11 months
    Title
    Mid-upper arm circumference-for-age Z-score of index child
    Time Frame
    10-11 months
    Title
    Amount of QPM reserved for home consumption
    Time Frame
    10-11 months
    Title
    Change in Height-for-age Z-score of index child
    Time Frame
    6-7 months
    Title
    Change in Height-for-age Z-score of index child
    Time Frame
    10-11 months
    Title
    Change in Weight-for-height Z-score of index child
    Time Frame
    6-7 months
    Title
    Change in Weight-for-height Z-score of index child
    Time Frame
    10-11 months
    Title
    Change in Mid-upper arm circumference-for-age Z-score of index child
    Time Frame
    6-7 months
    Title
    Change in Mid-upper arm circumference-for-age Z-score of index child
    Time Frame
    10-11 months
    Title
    Change in Weight-for-age Z-score of index child
    Time Frame
    6-7 months
    Title
    Change in Weight-for-age Z-score of index child
    Time Frame
    10-11 months
    Secondary Outcome Measure Information:
    Title
    Serum lysine
    Time Frame
    6-7 months
    Title
    Serum tryptophan
    Time Frame
    6-7 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    35 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Households with at least one child in the 6-35 month age range in August 2015, who had at least one household member attend a field day demonstrating Quality Protein Maize, and who provided informed consent for participation and data collection were eligible for inclusion. Exclusion Criteria: Households in the study areas that do not have a member who attends a field day demonstrating Quality Protein Maize or who do not have a child in the appropriate age range are excluded from the study. Furthermore, households where the mother or children did not intend on staying in the region for the study duration (until the completion of the endline survey) were excluded from the study. Finally, we excluded participants who do not have access to land for crop cultivation.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jessica Cohen, PhD
    Organizational Affiliation
    Harvard Chan School of Public Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    We will share completely deidentified data upon request after primary analyses have been been completed.
    Citations:
    PubMed Identifier
    23746772
    Citation
    Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6. Erratum In: Lancet. 2013. 2013 Aug 3;382(9890):396.
    Results Reference
    background
    PubMed Identifier
    18206223
    Citation
    Victora CG, Adair L, Fall C, Hallal PC, Martorell R, Richter L, Sachdev HS; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: consequences for adult health and human capital. Lancet. 2008 Jan 26;371(9609):340-57. doi: 10.1016/S0140-6736(07)61692-4. Erratum In: Lancet. 2008 Jan 26;371(9609):302.
    Results Reference
    background
    PubMed Identifier
    23746780
    Citation
    Ruel MT, Alderman H; Maternal and Child Nutrition Study Group. Nutrition-sensitive interventions and programmes: how can they help to accelerate progress in improving maternal and child nutrition? Lancet. 2013 Aug 10;382(9891):536-51. doi: 10.1016/S0140-6736(13)60843-0. Epub 2013 Jun 6. Erratum In: Lancet. 2013 Aug 10;382(9891):506.
    Results Reference
    background
    PubMed Identifier
    22251864
    Citation
    Masset E, Haddad L, Cornelius A, Isaza-Castro J. Effectiveness of agricultural interventions that aim to improve nutritional status of children: systematic review. BMJ. 2012 Jan 17;344:d8222. doi: 10.1136/bmj.d8222.
    Results Reference
    background
    PubMed Identifier
    22742612
    Citation
    Girard AW, Self JL, McAuliffe C, Olude O. The effects of household food production strategies on the health and nutrition outcomes of women and young children: a systematic review. Paediatr Perinat Epidemiol. 2012 Jul;26 Suppl 1:205-22. doi: 10.1111/j.1365-3016.2012.01282.x.
    Results Reference
    background
    PubMed Identifier
    23107551
    Citation
    Ghosh S, Suri D, Uauy R. Assessment of protein adequacy in developing countries: quality matters. Br J Nutr. 2012 Aug;108 Suppl 2:S77-87. doi: 10.1017/S0007114512002577.
    Results Reference
    background
    PubMed Identifier
    33355261
    Citation
    Donato K, McConnell M, Han D, Gunaratna NS, Tessema M, De Groote H, Cohen J. Behavioural insights to support increased consumption of quality protein maize by young children: a cluster randomised trial in Ethiopia. BMJ Glob Health. 2020 Dec;5(12):e002705. doi: 10.1136/bmjgh-2020-002705.
    Results Reference
    derived

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