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Completed

NCT Number: NCT02710760

Translating Adoption of Improved Varieties Into Nutritional Impact

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.

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Key information

Conditions

Malnutrition Behavior Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adoption Encouragement Treatment

Other

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

Other

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

  1. Consumption of any QPM by the index child in the last 24 hours

    Time frame: 6-7 months

  2. Amount of QPM consumed by the index child in the last 24 hours

    Time frame: 6-7 months

  3. Index child's proportion of total maize consumption that was QPM in the last 24 hours

    Time frame: 6-7 months

  4. Consumption of any QPM by the index child in the last week

    Time frame: 6-7 months

  5. Number of days in the last week that the index child ate any QPM

    Time frame: 6-7 months

  6. 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

  7. Height-for-age Z-score of index child

    Time frame: 6-7 months

  8. Weight-for-height Z-score of index child

    Time frame: 6-7 months

  9. Weight-for-age Z-score of index child

    Time frame: 6-7 months

  10. Mid-upper arm circumference-for-age Z-score of index child

    Time frame: 6-7 months

  11. Insulin-like growth factor I (continuous measurement)

    Time frame: 6-7 months

  12. Amount of QPM reserved for home consumption

    Time frame: 6-7 months

  13. Hectares of QPM planted

    Time frame: 6-7 months

  14. Serum transthyretin

    Time frame: 6-7 months

  15. Consumption of any QPM by the index child in the last 24 hours

    Time frame: 10-11 months

  16. Amount of QPM consumed by the index child in the last 24 hours

    Time frame: 10-11 months

  17. Index child's proportion of total maize consumption that was QPM in the last 24 hours

    Time frame: 10-11 months

  18. Consumption of any QPM by the index child in the last week

    Time frame: 10-11 months

  19. Number of days in the last week that the index child ate any QPM

    Time frame: 10-11 months

  20. 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

  21. Height-for-age Z-score of index child

    Time frame: 10-11 months

  22. Weight-for-height Z-score of index child

    Time frame: 10-11 months

  23. Weight-for-age Z-score of index child

    Time frame: 10-11 months

  24. Mid-upper arm circumference-for-age Z-score of index child

    Time frame: 10-11 months

  25. Amount of QPM reserved for home consumption

    Time frame: 10-11 months

  26. Change in Height-for-age Z-score of index child

    Time frame: 6-7 months

  27. Change in Height-for-age Z-score of index child

    Time frame: 10-11 months

  28. Change in Weight-for-height Z-score of index child

    Time frame: 6-7 months

  29. Change in Weight-for-height Z-score of index child

    Time frame: 10-11 months

  30. Change in Mid-upper arm circumference-for-age Z-score of index child

    Time frame: 6-7 months

  31. Change in Mid-upper arm circumference-for-age Z-score of index child

    Time frame: 10-11 months

  32. Change in Weight-for-age Z-score of index child

    Time frame: 6-7 months

  33. Change in Weight-for-age Z-score of index child

    Time frame: 10-11 months

Secondary outcomes

  1. Serum lysine

    Time frame: 6-7 months

  2. Serum tryptophan

    Time frame: 6-7 months

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Agricultural Technology Adoption Initiative
  • CIMMYT International Maize and Wheat Improvement Center
  • Ethiopian Public Health Institute

Registry information

Official study 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

Acronym: QPM

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2016
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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