Improving Infant Nutrition in Southern Ethiopia

Not Applicable

Completed

• Conditions: Nutrition Disorders

• Registration Number: NCT03423472
• Lead Sponsor: Emory University

Brief Summary

This cluster randomized controlled trial will test the effect of the promotion of vitamin A-rich orange flesh sweet potato (OFSP) production and nutrition education on vitamin A and energy intake, including any added value of the Healthy Baby Toolkit.

Detailed Description

Child stunting and vitamin A deficiency are persistent public health problems in Ethiopia.

Quality Diets for Better Health (QDBH) is a European Union-funded project led by the International Potato Center (CIP), in partnership with People in Need (PIN), Emory University and with support of governmental organizations and local universities. The 54 month-project strives to improve diet quality, primarily of women and young children, through the promotion of vitamin A-rich orange flesh sweetpotato (OFSP) production and nutrition education in 41 kebeles (communities) in SNNPR, reaching an estimated 15000 households. In addition, households in a subset of communities will receive a Healthy Baby Toolkit, consisting of a marked bowl, slotted spoon, and illustrated counseling card. The Healthy Baby Toolkit is designed to promote optimal complementary feeding practices of infants and young children 6 to 23 months, namely meal volume, meal frequency, and meal thickness.

As part of this project, Emory University will conduct a longitudinal, cluster randomized controlled trial in 20 kebeles to test the effect of the project on vitamin A and energy intake, including any added value of the Healthy Baby Toolkit.

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2018-02-04
• Study First Posted: 2018-02-06
• Study Start: 2018-02-08
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 605

Inclusion Criteria

1. Participation in a Healthy Living Club (only a criteria for those in partial or full intervention arms)
2. Infant aged birth to 5 months
3. Primary caregiver and head of household (if different from primary caregiver) available and provides consent for survey

Exclusion Criteria

1. Serious health problem (for example, HIV/AIDS or congenital defect)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in vitamin A intake of young children	Baseline, approximately 6 months at midline, and approximately 1 year at endline	Multiple linear regression will be used to explore the effect of intervention status on vitamin A intake, while controlling for covariates and assessing interaction. The Ethiopian Food Composition Tables I-IV will be used to derive the data from dietary data collected at midline and at endline.
Change in energy intake of young children	Baseline, approximately 6 months at midline, and approximately 1 year at endline	Multiple linear regression will be used to explore the effect of intervention status on energy intake, while controlling for covariates and assessing interaction. The Ethiopian Food Composition Tables I-IV will be used to derive the data from dietary data collected at midline and at endline.

Secondary Outcome Measures

Name	Time	Method
Validation of survey-based indicators of meal volume for children ages 6 to 11 months	Approximately 6 months at midline, and approximately 1 year at endline	Nutrient intake data collected at midline and endline will be compared with caregiver responses to indicator questions using combinations of the following: Bland Altman plots, Pearson's correlation, sensitivity and specificity, and/or Receiver Operating Characteristic Curves.
Validation of survey-based indicators of food consistency for children ages 6 to 11 months	Approximately 6 months at midline, and approximately 1 year at endline	Nutrient density data collected at midline and endline will be compared with caregiver responses to indicator questions using combinations of the following: Bland Altman plots, Pearson's correlation, sensitivity and specificity, and/or Receiver Operating Characteristic Curves.

Trial Locations

Locations (2)

Emory University; 🇺🇸 Atlanta, Georgia, United States

International Potato Center (CIP); 🇪🇹 Sīdamo, Southern Nations, Nationalities, And Peoples' Region (snnpr), Ethiopia