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Improving Infant Nutrition in Southern Ethiopia

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ClinicalTrials.gov Identifier: NCT03423472
Recruitment Status : Completed
First Posted : February 6, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Amy Webb Girard, Emory University

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.

Condition or disease Intervention/treatment Phase
Nutrition Disorders Behavioral: Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake Behavioral: Healthy Baby Toolkit Behavioral: Standart of care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 605 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Orange Fleshed Sweet Potato Promotion and the Healthy Baby Toolkit in Southern Ethiopia: a Cluster Randomized Controlled Trial
Actual Study Start Date : February 8, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nutrition Vitamin A

Arm Intervention/treatment
Experimental: 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
Behavioral: 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.

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.

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

Active Comparator: 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
Behavioral: 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.

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




Primary Outcome Measures :
  1. Change in vitamin A intake of young children [ Time Frame: Baseline, approximately 6 months at midline, and approximately 1 year at endline ]
    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.

  2. Change in energy intake of young children [ Time Frame: Baseline, approximately 6 months at midline, and approximately 1 year at endline ]
    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 :
  1. Validation of survey-based indicators of meal volume for children ages 6 to 11 months [ Time Frame: Approximately 6 months at midline, and approximately 1 year at endline ]
    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.

  2. Validation of survey-based indicators of food consistency for children ages 6 to 11 months [ Time Frame: Approximately 6 months at midline, and approximately 1 year at endline ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423472


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Ethiopia
International Potato Center (CIP)
Sīdamo, Southern Nations, Nationalities, And Peoples' Region (snnpr), Ethiopia
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Amy Girard Emory University
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Responsible Party: Amy Webb Girard, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03423472    
Other Study ID Numbers: IRB00099964
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amy Webb Girard, Emory University:
Nutrition
Women
Young children
Ethiopia
Vitamin A
Orange flesh sweet potato
Additional relevant MeSH terms:
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Nutrition Disorders
Vitamin A
Vitamins
Micronutrients
Physiological Effects of Drugs