Improving Infant Nutrition in Southern Ethiopia

Evaluation of Orange Fleshed Sweet Potato Promotion and the Healthy Baby Toolkit in Southern Ethiopia: a Cluster Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Nutrition Disorders
• Intervention / Treatment: Behavioral: Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake; Behavioral: Healthy Baby Toolkit; Behavioral: Standart of care

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 Type: Interventional
• Enrollment (Actual): 605
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ethiopia
  • Southern Nations, Nationalities, And Peoples' Region (snnpr)
    • Sīdamo, Southern Nations, Nationalities, And Peoples' Region (snnpr), Ethiopia
      • International Potato Center (CIP)
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full intervention; Healthy Baby Toolkit (HBT) in addition to Orange Fleshed Sweet Potato (OFSP) agriculture promotion and education on family nutrition, with special emphasis on women and children < 2y; especially diet diversity and vitamin A intake	Behavioral: Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake; Support to farmers to grow and store OFSP in the form of agricultural extension, community based trainings and supplies, while simultaneously increasing community demand for OFSP through community-based Healthy Living Clubs. The Clubs promote OFSP, provide nutrition education, and conduct community mobilization events and social marketing of OFSP and OFSP-based processed products. Special emphasis is on women and children < 2y; especially diet diversity and vitamin A intake.; Behavioral: Healthy Baby Toolkit; The toolkit consists of a demarcated bowl, a slotted spoon, and a counseling card. The demarcations on the bowl guide caregivers on age-specific meal volume and frequency. The slotted spoon promotes thicker food consistency - and therefore nutrient density - by cuing caregivers when food drips through the slots. The counseling card relies on images rather than text to reinforce messages of the previous two instruments, promote dietary diversity, and promote hygienic food preparation.; Behavioral: Standart of care; Government standard of care for nutrition education through the Health Development Army
Active Comparator: Partial intervention; Orange Fleshed Sweet Potato (OFSP) agriculture promotion and education on family nutrition, with special emphasis on women and children < 2y; especially diet diversity and vitamin A intake	Behavioral: Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake; Support to farmers to grow and store OFSP in the form of agricultural extension, community based trainings and supplies, while simultaneously increasing community demand for OFSP through community-based Healthy Living Clubs. The Clubs promote OFSP, provide nutrition education, and conduct community mobilization events and social marketing of OFSP and OFSP-based processed products. Special emphasis is on women and children < 2y; especially diet diversity and vitamin A intake.; Behavioral: Standart of care; Government standard of care for nutrition education through the Health Development Army
Other: Control; Government standard of care for nutrition education through the Health Development Army	Behavioral: Standart of care; Government standard of care for nutrition education through the Health Development Army

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vitamin A intake of young children	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.	Baseline, approximately 6 months at midline, and approximately 1 year at endline
Change in energy intake of young children	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.	Baseline, approximately 6 months at midline, and approximately 1 year at endline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of survey-based indicators of meal volume for children ages 6 to 11 months	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.	Approximately 6 months at midline, and approximately 1 year at endline
Validation of survey-based indicators of food consistency for children ages 6 to 11 months	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.	Approximately 6 months at midline, and approximately 1 year at endline

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Amy Girard, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: February 4, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Women; Nutrition; Ethiopia; Vitamin A; Young children; Orange flesh sweet potato
• Additional Relevant MeSH Terms: Nutrition Disorders; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: IRB00099964

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No