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临床试验/NCT03423472
NCT03423472已完成不适用

Evaluation of Orange Fleshed Sweet Potato Promotion and the Healthy Baby Toolkit in Southern Ethiopia: a Cluster Randomized Controlled Trial

Emory University3 个研究点 分布在 2 个国家目标入组 605 人开始时间: 2018年2月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
605
试验地点
3
主要终点
Change in vitamin A intake of young children

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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

干预措施: Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake (Behavioral)

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

干预措施: Healthy Baby Toolkit (Behavioral)

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

干预措施: Standart of care (Behavioral)

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

干预措施: Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake (Behavioral)

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

干预措施: Standart of care (Behavioral)

Control

Other

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

干预措施: Standart of care (Behavioral)

结局指标

主要结局

Change in vitamin A intake of young children

时间窗: 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.

Change in energy intake of young children

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Webb Girard

Assistant Professor

Emory University

研究点 (3)

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