Improving Infant Nutrition in Southern Ethiopia

NCT ID: NCT03423472

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

605 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-08

Study Completion Date

2019-03-01

Brief Summary

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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

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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.

Conditions

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Nutrition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake

Intervention Type BEHAVIORAL

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.

Standart of care

Intervention Type BEHAVIORAL

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

Control

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

Group Type OTHER

Standart of care

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Standart of care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Amy Webb Girard

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy Girard

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

International Potato Center (CIP)

Sīdamo, Southern Nations, Nationalities, and Peoples' Region (snnpr), Ethiopia

Site Status

Countries

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United States Ethiopia

Other Identifiers

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IRB00099964

Identifier Type: -

Identifier Source: org_study_id

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