Translating Adoption of Improved Varieties Into Nutritional Impact

Malnutrition Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710760
• Other study ID #: IRB14-3255
• Status: Completed
• Phase: N/A
• First received: February 29, 2016
• Last updated: March 8, 2017
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: March 2017
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 978
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 35 Months

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Harvard School of Public Health	Agricultural Technology Adoption Initiative, CIMMYT International Maize and Wheat Improvement Center, Ethiopian Public Health Institute

References & Publications (6)

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):427-51. doi: 10.1016/S0140-6736(13)60937-X. Review. Erratum in: Lancet. 2013. 2013 Aug 3;382(9890):396. — View 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. — View 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. Review. — View 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. Review. — View 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. Erratum in: Lancet. 2013 Aug 10;382(9891):506. — View 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. Review. Erratum in: Lancet. 2008 Jan 26;371(9609):302. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption of any QPM by the index child in the last 24 hours		6-7 months
Primary	Amount of QPM consumed by the index child in the last 24 hours		6-7 months
Primary	Index child's proportion of total maize consumption that was QPM in the last 24 hours		6-7 months
Primary	Consumption of any QPM by the index child in the last week		6-7 months
Primary	Number of days in the last week that the index child ate any QPM		6-7 months
Primary	Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children		6-7 months
Primary	Height-for-age Z-score of index child		6-7 months
Primary	Weight-for-height Z-score of index child		6-7 months
Primary	Weight-for-age Z-score of index child		6-7 months
Primary	Mid-upper arm circumference-for-age Z-score of index child		6-7 months
Primary	Insulin-like growth factor I (continuous measurement)		6-7 months
Primary	Amount of QPM reserved for home consumption		6-7 months
Primary	Hectares of QPM planted		6-7 months
Primary	Serum transthyretin		6-7 months
Primary	Consumption of any QPM by the index child in the last 24 hours		10-11 months
Primary	Amount of QPM consumed by the index child in the last 24 hours		10-11 months
Primary	Index child's proportion of total maize consumption that was QPM in the last 24 hours		10-11 months
Primary	Consumption of any QPM by the index child in the last week		10-11 months
Primary	Number of days in the last week that the index child ate any QPM		10-11 months
Primary	Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children		10-11 months
Primary	Height-for-age Z-score of index child		10-11 months
Primary	Weight-for-height Z-score of index child		10-11 months
Primary	Weight-for-age Z-score of index child		10-11 months
Primary	Mid-upper arm circumference-for-age Z-score of index child		10-11 months
Primary	Amount of QPM reserved for home consumption		10-11 months
Primary	Change in Height-for-age Z-score of index child		6-7 months
Primary	Change in Height-for-age Z-score of index child		10-11 months
Primary	Change in Weight-for-height Z-score of index child		6-7 months
Primary	Change in Weight-for-height Z-score of index child		10-11 months
Primary	Change in Mid-upper arm circumference-for-age Z-score of index child		6-7 months
Primary	Change in Mid-upper arm circumference-for-age Z-score of index child		10-11 months
Primary	Change in Weight-for-age Z-score of index child		6-7 months
Primary	Change in Weight-for-age Z-score of index child		10-11 months
Secondary	Serum lysine		6-7 months
Secondary	Serum tryptophan		6-7 months