Improving Infant Nutrition in Southern Ethiopia

NCT03423472 | Completed DMC

• 1 other identifier: IRB00099964
• Study Type: interventional
• Target: 605
• Locations: 2 countries
• Sites: 2

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.

Conditions

Nutrition Disorders

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Validation of survey-based indicators of meal volume for children ages 6 to 11 months

  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

  Approximately 6 months at midline, and approximately 1 year at endline

Study Arms (3)

Full intervention

EXPERIMENTAL

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; Behavioral: Healthy Baby Toolkit; Behavioral: Standart of care

Partial intervention

ACTIVE COMPARATOR

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; Behavioral: Standart of care

Control

OTHER

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

Behavioral: Standart of care

Interventions

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

Full intervention; Partial intervention

Healthy Baby Toolkit 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.

Full intervention

Standart of care BEHAVIORAL

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

Control; Full intervention; Partial intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. Serious health problem (for example, HIV/AIDS or congenital defect)

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

Location

International Potato Center (CIP)

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

Location

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Amy Girard

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: February 6, 2018
• Study Start: February 8, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

ET (1); US (1)