Clinical trial NCT03423472: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Disorders
Keywords: Nutrition
Women
Young children
Ethiopia
Vitamin A
Orange flesh sweet potato
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 605
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in vitamin A intake of young children
timeFrame: Baseline, approximately 6 months at midline, and approximately 1 year at endline
measure: Change in energy intake of young children
timeFrame: Baseline, approximately 6 months at midline, and approximately 1 year at endline
Secondary outcomes:
measure: Validation of survey-based indicators of meal volume for children ages 6 to 11 months
timeFrame: Approximately 6 months at midline, and approximately 1 year at endline
measure: Validation of survey-based indicators of food consistency for children ages 6 to 11 months
timeFrame: Approximately 6 months at midline, and approximately 1 year at endline
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Sīdamo
country: Ethiopia
facility: International Potato Center (CIP)
state: Southern Nations, Nationalities, And Peoples' Region (snnpr)
Study officials:
affiliation: Emory University
name: Amy Girard
role: PRINCIPAL_INVESTIGATOR
References: