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Improving Infant Nutrition in Southern Ethiopia

Primary Purpose

Nutrition Disorders

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake
Healthy Baby Toolkit
Standart of care
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nutrition Disorders focused on measuring Nutrition, Women, Young children, Ethiopia, Vitamin A, Orange flesh sweet potato

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Emory University
  • International Potato Center (CIP)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Full intervention

Partial intervention

Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 20, 2017
Last Updated
April 2, 2019
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03423472
Brief Title
Improving Infant Nutrition in Southern Ethiopia
Official Title
Evaluation of Orange Fleshed Sweet Potato Promotion and the Healthy Baby Toolkit in Southern Ethiopia: a Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutrition Disorders
Keywords
Nutrition, Women, Young children, Ethiopia, Vitamin A, Orange flesh sweet potato

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
605 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Partial intervention
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
Other
Arm Description
Government standard of care for nutrition education through the Health Development Army
Intervention Type
Behavioral
Intervention Name(s)
Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake
Intervention Description
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
Intervention Name(s)
Healthy Baby Toolkit
Intervention Description
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
Intervention Name(s)
Standart of care
Intervention Description
Government standard of care for nutrition education through the Health Development Army
Primary Outcome Measure Information:
Title
Change in vitamin A intake of young children
Description
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.
Time Frame
Baseline, approximately 6 months at midline, and approximately 1 year at endline
Title
Change in energy intake of young children
Description
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.
Time Frame
Baseline, approximately 6 months at midline, and approximately 1 year at endline
Secondary Outcome Measure Information:
Title
Validation of survey-based indicators of meal volume for children ages 6 to 11 months
Description
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.
Time Frame
Approximately 6 months at midline, and approximately 1 year at endline
Title
Validation of survey-based indicators of food consistency for children ages 6 to 11 months
Description
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.
Time Frame
Approximately 6 months at midline, and approximately 1 year at endline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participation in a Healthy Living Club (only a criteria for those in partial or full intervention arms) Infant aged birth to 5 months 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Girard
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
International Potato Center (CIP)
City
Sīdamo
State/Province
Southern Nations, Nationalities, And Peoples' Region (snnpr)
Country
Ethiopia

12. IPD Sharing Statement

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Improving Infant Nutrition in Southern Ethiopia

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