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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03423472
Enrollment
605
Registered
2018-02-06
Start date
2018-02-08
Completion date
2019-03-01
Last updated
2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition Disorders

Keywords

Nutrition, Women, Young children, Ethiopia, Vitamin A, Orange flesh sweet potato

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.

Interventions

BEHAVIORALOrange 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.

BEHAVIORALHealthy 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.

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

Sponsors

Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in vitamin A intake of young childrenBaseline, approximately 6 months at midline, and approximately 1 year at endlineMultiple 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 childrenBaseline, approximately 6 months at midline, and approximately 1 year at endlineMultiple 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

MeasureTime frameDescription
Validation of survey-based indicators of meal volume for children ages 6 to 11 monthsApproximately 6 months at midline, and approximately 1 year at endlineNutrient 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 monthsApproximately 6 months at midline, and approximately 1 year at endlineNutrient 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.

Countries

Ethiopia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026