Assessing Feasibility and Program Effectiveness of Home Fortification of Complementary Foods in Bihar: A Cluster Randomized Community Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11,861
- 试验地点
- 1
- 主要终点
- Change in hemoglobin concentration
研究概览
简要总结
This study evaluates the program effectiveness of home fortification along with infant and young child feeding (IYCF) counseling as a strategy to address anemia and complementary feedings gaps in a program setting of the Integrated Family Health Initiative being implemented by CARE India (a non-profit organization) in partnership with the Government of Bihar. The study also seeks to assess the field level worker experience with counseling and dissemination of home fortification products.
详细描述
This study evaluates the program effectiveness of home fortification along with infant and young child feeding (IYCF) counseling as a strategy to address anemia and complementary feedings gaps in a program setting of the Integrated Family Health Initiative being implemented by CARE India (a non-profit organization) in partnership with the Government of Bihar.The key objectives of this study are to examine acceptability and utilization by target population, assess impact on infant and young child feeding (IYCF) practices, evaluate impact on child growth, evaluate impact on hemoglobin concentration, and assess front line worker experience and motivation to disseminate enhanced counseling and home fortification products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Randomly selected children living within Health-Sub Centers (HSC) in West Champaran Bihar
排除标准
- •Children less than six months of age
- •Children greater than eighteen months of age
研究组 & 干预措施
Home Fortification and Counseling
Participants aged 6 to 18 months will receive a daily supplement of vitamins and minerals in dry powder form to be taken once daily for up to nine months or up to 240 sachets. Participant caregivers will also receive improved young child feeding practices (IYCF) counseling from a front line worker.
干预措施: Home Fortification Product (HFP) (Dietary Supplement)
Home Fortification and Counseling
Participants aged 6 to 18 months will receive a daily supplement of vitamins and minerals in dry powder form to be taken once daily for up to nine months or up to 240 sachets. Participant caregivers will also receive improved young child feeding practices (IYCF) counseling from a front line worker.
干预措施: Infant and Young Child Feeding (IYCF) Practices Counseling (Other)
Improved Child Feeding Practices (IYCF) Counseling
Participants ages 6 to 18 months will receive improved young child feeding practices (IYCF) counseling from a front line worker.
干预措施: Infant and Young Child Feeding (IYCF) Practices Counseling (Other)
结局指标
主要结局
Change in hemoglobin concentration
时间窗: Baseline (month 0), Endline (month 12)
Hemoglobin concentration will be collected by taking a small blood sample via finger or heal prick. A hemoglobin level below 7 g/dl is considered severe anemia.
Number of home fortification sachets consumed
时间窗: Within 31 days (Up to 31 days)
The number of sachets consumed versus those received by participants within thirty one days of distribution.
Number of home fortification sachets consumed
时间窗: Within 7 days (Up to 7 days)
The number of sachets consumed versus those received by participants within seven days of distribution.
次要结局
- Quantity of food(Within 24 hours (Up to one day))
- Consistency of foods(Within 24 hours (Up to one day))
- Front-line worker motivation(Endline (Up to 9 months))
- Change in body length(Baseline (month 0), Endline (month 12))
- Complementary Feeding Rate(Month 6 (Up to six months))
- A-not-B task performance(Endline (month 12))
- Change Developmental Milestones Checklist-II (DMC-II)(Baseline (month 0), Endline (month 12))
- Number of daily meals(Within 24 hours (Up to one day))
- Elicited imitation task performance(Endline (month 12))
- Frequency of home visits(Up to 12 months)
- Frequency of home fortification sachet distribution(Up to twelve months)
- Change in body weight(Baseline (month 0), Endline (month 12))
- Diversity of foods(Within 24 hours (Up to one day))
研究者
Reynaldo Martorell
Professor
Emory University