Clinical trial NCT02710760: Translating Adoption of Improved Varieties Into Nutritional Impact
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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Biomarkers
Child Nutrition Sciences
Economics, Behavioral
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: CIMMYT International Maize and Wheat Improvement Center
name: Ethiopian Public Health Institute
name: Agricultural Technology Adoption Initiative
First posted: 2016-03-17
Enrollment: 978
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Consumption of any QPM by the index child in the last 24 hours
timeFrame: 6-7 months
measure: Amount of QPM consumed by the index child in the last 24 hours
timeFrame: 6-7 months
measure: Index child's proportion of total maize consumption that was QPM in the last 24 hours
timeFrame: 6-7 months
measure: Consumption of any QPM by the index child in the last week
timeFrame: 6-7 months
measure: Number of days in the last week that the index child ate any QPM
timeFrame: 6-7 months
measure: Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children
timeFrame: 6-7 months
measure: Height-for-age Z-score of index child
timeFrame: 6-7 months
measure: Weight-for-height Z-score of index child
timeFrame: 6-7 months
measure: Weight-for-age Z-score of index child
timeFrame: 6-7 months
measure: Mid-upper arm circumference-for-age Z-score of index child
timeFrame: 6-7 months
measure: Insulin-like growth factor I (continuous measurement)
timeFrame: 6-7 months
measure: Amount of QPM reserved for home consumption
timeFrame: 6-7 months
measure: Hectares of QPM planted
timeFrame: 6-7 months
measure: Serum transthyretin
timeFrame: 6-7 months
measure: Consumption of any QPM by the index child in the last 24 hours
timeFrame: 10-11 months
measure: Amount of QPM consumed by the index child in the last 24 hours
timeFrame: 10-11 months
measure: Index child's proportion of total maize consumption that was QPM in the last 24 hours
timeFrame: 10-11 months
measure: Consumption of any QPM by the index child in the last week
timeFrame: 10-11 months
measure: Number of days in the last week that the index child ate any QPM
timeFrame: 10-11 months
measure: Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children
timeFrame: 10-11 months
measure: Height-for-age Z-score of index child
timeFrame: 10-11 months
measure: Weight-for-height Z-score of index child
timeFrame: 10-11 months
measure: Weight-for-age Z-score of index child
timeFrame: 10-11 months
measure: Mid-upper arm circumference-for-age Z-score of index child
timeFrame: 10-11 months
measure: Amount of QPM reserved for home consumption
timeFrame: 10-11 months
measure: Change in Height-for-age Z-score of index child
timeFrame: 6-7 months
measure: Change in Height-for-age Z-score of index child
timeFrame: 10-11 months
measure: Change in Weight-for-height Z-score of index child
timeFrame: 6-7 months
measure: Change in Weight-for-height Z-score of index child
timeFrame: 10-11 months
measure: Change in Mid-upper arm circumference-for-age Z-score of index child
timeFrame: 6-7 months
measure: Change in Mid-upper arm circumference-for-age Z-score of index child
timeFrame: 10-11 months
measure: Change in Weight-for-age Z-score of index child
timeFrame: 6-7 months
measure: Change in Weight-for-age Z-score of index child
timeFrame: 10-11 months
Secondary outcomes:
measure: Serum lysine
timeFrame: 6-7 months
measure: Serum tryptophan
timeFrame: 6-7 months
Other outcomes:
Locations:
Study officials:
affiliation: Harvard Chan School of Public Health
name: Jessica Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.