Improving Infant Nutrition in Southern Ethiopia

Nutrition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423472
• Other study ID #: IRB00099964
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Nutrition Disorders

Intervention

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.
• 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.
• Standart of care
Government standard of care for nutrition education through the Health Development Army

Locations

Country	Name	City	State
Ethiopia	International Potato Center (CIP)	Sidamo	Southern Nations, Nationalities, And Peoples' Region (snnpr)
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Countries where clinical trial is conducted

United States,  Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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