Crowd Funding and Social Networks as a Novel Mechanism to Promote Sustainable Physical Growth and Positive Psychosocial and Neurodevelopmental Outcomes in Severely Stunted Guatemalan Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Change in Height/Length for Age Z Score
研究概览
简要总结
This study seeks to evaluate the impact of an intensive home-based education intervention targeting severely stunted Guatemalan children for catch up growth and improved development. Half of the children in the study will receive standard of care, which includes micronutrient supplementation and a food ration. The other half of children in the study will receive, in addition to the above, home-based dietary assessment and individualized parental nutrition education.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child aged 6-24 months at time of enrollment
- •Height/length for age Z score of less than -2.5
- •Child lives with parent/legal guardian
排除标准
- •Presence of acute malnutrition (weight for length/height Z score of less than -2)
- •Presence of other severe medical illness (e.g. congenital heart disease, genetic abnormality)
研究组 & 干预措施
Standard of Care Arm
In this arm enrolled children will receive the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement.
干预措施: Standard-of-care nutrition support (Dietary Supplement)
Home-based Education
In the intervention arm, children will receive the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement. In addition, they will receive monthly home visits from a community health promoter who will provide detailed dietary assessments and individualized dietary coaching and education to parents.
干预措施: Home-based nutrition education (Behavioral)
Home-based Education
In the intervention arm, children will receive the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement. In addition, they will receive monthly home visits from a community health promoter who will provide detailed dietary assessments and individualized dietary coaching and education to parents.
干预措施: Standard-of-care nutrition support (Dietary Supplement)
结局指标
主要结局
Change in Height/Length for Age Z Score
时间窗: Baseline, 6 months
Change in height/length over 6 months. Tool used is the WHO Child Growth Reference Standards. Change values calculated as: 6 month (z-score) minus Baseline (z-score).
次要结局
- Cognitive Development(Baseline, 6 months)
- Socioemotional Development(Baseline, 6 months)
- Gross Motor Development(Baseline, 6 months)
- Fine Motor Development(Baseline, 6 months)
- Receptive Language Development(Baseline, 6 months)
- Expressive Language Development(Baseline, 6 months)
- Minimum Diet Diversity(0 months, 6 months)
- Minimum Meal Frequency(0 months, 6 months)
- Minimum Acceptable Diet(0 months, 6 months)