Impact of Combined Nutrition, Responsive Parenting, and Health Intervention on Childhood Development Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 2,240
- 试验地点
- 4
- 主要终点
- Cognitive Development
研究概览
简要总结
This study aims to evaluate whether early childhood development is improved by a bundled set of interventions that promote responsive stimulation and improved nutrition by the provision of eggs and dried fish (nutrient-dense animal source foods), and whether, in combination, these stimulation and nutrition interventions are more effective than responsive stimulation or food provision alone.
详细描述
The BUNDLE study will examine the effects of a 7-month nutrition and caregiving intervention for female and male caregivers delivered by trained adult community facilitators in rural communities across Liberia. The study will use a four-arm 2x2 factorial cluster randomized design to test the effectiveness of the interventions on primary outcomes of child cognitive, language, motor, and socio-emotional development. In this study, 2240 children aged 6 to 30 months will be recruited from 160 rural communities randomized to a comparison arm or one of the three intervention arms. The comparison arm will receive the local standard of care. Three intervention arms will also receive either a responsive stimulation intervention with female and male caregivers, provision of eggs and dried fish accompanied by nutrition education, or responsive stimulation + provision of eggs and dried fish. We hypothesize that child development will be improved in all intervention arms compared to the comparison arm and in the combined intervention arm compared to the single intervention arms.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resides in selected community in Liberia
- •Household has a child aged 6-30 months at study enrollment
- •Child has a primary female caregiver and second (male or female) caregiver ≥ 18 years of age
- •Caregivers and child intend to continue residing in the study area for the follow-up duration
- •Both primary and second caregiver provide informed consent
排除标准
- •Children with known allergies to eggs or fish
- •Caregivers with cognitive and severe physical disabilities who are unable to implement intervention activities
- •Children with developmental disabilities
结局指标
主要结局
Cognitive Development
时间窗: 7 months
Change from baseline to end-line in cognitive composite score on Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 162 with higher scores representing higher cognitive development.
Language Development
时间窗: 7 months
Change from baseline to end-line in language composite score on the Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 158 with higher scores representing higher language development.
Motor Development
时间窗: 7 months
Change from baseline to end-line in motor composite score on the Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 208 with higher scores representing higher motor development.
Socio-emotional Development
时间窗: 7 months
Change from baseline to end-line in socio-emotional score on the Wolke Behavior Rating scale. Scores range from 9 to 81 with higher scores representing higher socio-emotional development.
次要结局
- Child height or length-for-age z-score(7 months)
- Child weight-for-age z-score(7 months)
- Child weight-for-height (or length) z-score(7 months)
- Child egg consumption(7 months)
- Child fish consumption(7 months)
- Child dietary diversity(7 months)
- Responsive feeding(7 months)
- Early learning opportunities(7 months)
- Primary female caregiver social support(7 months)
- Primary female caregiver responsive caregiver-child interactions(7 months)
- Male caregiver responsive caregiver-child interactions(7 months)
- Secondary female caregiver responsive caregiver-child interactions(7 months)
- Primary female caregiver depression(7 months)
- Male caregiver depression(7 months)
- Secondary female caregiver depression(7 months)
- Primary female caregiver anxiety(7 months)
- Male caregiver anxiety(7 months)
- Secondary female caregiver anxiety(7 months)
- Primary female caregiver positive mental health(7 months)
- Male caregiver positive mental health(7 months)
- Secondary female caregiver positive mental health(7 months)
- Primary female caregiver stress(7 months)
- Male caregiver stress(7 months)
- Secondary female caregiver stress(7 months)
- Primary female caregiver Co-parenting(7 months)
- Male caregiver Co-parenting(7 months)
- Secondary female caregiver Co-parenting(7 months)
研究者
Leila Larson
Assistant Professor
University of South Carolina