Overview

This trial is active, not recruiting.

Condition malnutrition
Treatments adoption encouragement treatment, consumption encouragement treatment
Sponsor Harvard School of Public Health
Collaborator CIMMYT International Maize and Wheat Improvement Center
Start date July 2015
End date September 2016
Trial size 978 participants
Trial identifier NCT02710760, IRB14-3255

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
Households in the control group receive no special treatment.
(Experimental)
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.
adoption encouragement treatment
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.
(Experimental)
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.
adoption encouragement treatment
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.
consumption encouragement treatment
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 Outcomes

Measure
Consumption of any QPM by the index child in the last 24 hours
time frame: 6-7 months
Amount of QPM consumed by the index child in the last 24 hours
time frame: 6-7 months
Index child's proportion of total maize consumption that was QPM in the last 24 hours
time frame: 6-7 months
Consumption of any QPM by the index child in the last week
time frame: 6-7 months
Number of days in the last week that the index child ate any QPM
time frame: 6-7 months
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
Height-for-age Z-score of index child
time frame: 6-7 months
Weight-for-height Z-score of index child
time frame: 6-7 months
Weight-for-age Z-score of index child
time frame: 6-7 months
Mid-upper arm circumference-for-age Z-score of index child
time frame: 6-7 months
Insulin-like growth factor I (continuous measurement)
time frame: 6-7 months
Amount of QPM reserved for home consumption
time frame: 6-7 months
Hectares of QPM planted
time frame: 6-7 months
Serum transthyretin
time frame: 6-7 months
Consumption of any QPM by the index child in the last 24 hours
time frame: 10-11 months
Amount of QPM consumed by the index child in the last 24 hours
time frame: 10-11 months
Index child's proportion of total maize consumption that was QPM in the last 24 hours
time frame: 10-11 months
Consumption of any QPM by the index child in the last week
time frame: 10-11 months
Number of days in the last week that the index child ate any QPM
time frame: 10-11 months
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
Height-for-age Z-score of index child
time frame: 10-11 months
Weight-for-height Z-score of index child
time frame: 10-11 months
Weight-for-age Z-score of index child
time frame: 10-11 months
Mid-upper arm circumference-for-age Z-score of index child
time frame: 10-11 months
Amount of QPM reserved for home consumption
time frame: 10-11 months
Change in Height-for-age Z-score of index child
time frame: 6-7 months
Change in Height-for-age Z-score of index child
time frame: 10-11 months
Change in Weight-for-height Z-score of index child
time frame: 6-7 months
Change in Weight-for-height Z-score of index child
time frame: 10-11 months
Change in Mid-upper arm circumference-for-age Z-score of index child
time frame: 6-7 months
Change in Mid-upper arm circumference-for-age Z-score of index child
time frame: 10-11 months
Change in Weight-for-age Z-score of index child
time frame: 6-7 months
Change in Weight-for-age Z-score of index child
time frame: 10-11 months

Secondary Outcomes

Measure
Serum lysine
time frame: 6-7 months
Serum tryptophan
time frame: 6-7 months

Eligibility Criteria

Male or female participants from 6 months up to 35 months old.

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.

Additional Information

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
Principal investigator Jessica Cohen, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Harvard School of Public Health.