Impact of an integrated health, nutrition and early child stimulation intervention package delivered to preterm and small for gestational babies during infancy, on body composition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,048
- 试验地点
- 1
- 主要终点
- Mean Attained Lean mass
研究概览
简要总结
Preterm and small for gestational age (SGA) infants represent a significant public health concern, particularly in South Asia, where they account for nearly 41% of live births. These infants face dual risks of excess fat gain and poor skeletal development, increasing their susceptibility to adult non-communicable diseases (NCDs) through metabolic programming. Current evidence suggests these risks stem from suboptimal growth trajectories and early-life nutritional deficiencies. While interventions targeting body composition have shown some promise, evidence on comprehensive approaches is sparse, particularly in low- and middle-income settings.
This study, embedded in an ongoing RCT (pubmed.ncbi.nlm.nih.gov/38331842/), seeks to assess the impact of integrated health, nutrition, and early child stimulation interventions on body composition at 12 months of age. Interventions include breastfeeding support, growth monitoring, nutritional supplementation with a milk cereal mix, and early child stimulation activities. Using a fan-beam Dual-energy X-ray Absorptiometry (DXA) with infant-adapted Lunar software, it will measure lean mass, fat mass, and bone mineral density (BMD). The findings aim to optimize growth interventions for preterm and SGA infants, informing policies to mitigate the dual burden of malnutrition and NCD risk in vulnerable populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Month(s) 至 13.00 Month(s)(—)
- 性别
- All
入选标准
- •Children participating in Small Babies Trial
- •Completed 12 months of age.
排除标准
- •Non-Consent
- •Not Available at the time of assessment.
结局指标
主要结局
Mean Attained Lean mass
时间窗: 12 months of age
次要结局
- Bone mineral density (g/cm²)(12 months of age)
- Regional fat distribution(12 months of age)
- Differential effect on body composition in preterm SGA, term SGA, and preterm AGA infants(12 months of age)
- Fat mass (g)(12 months of age)
研究者
Dr Ranadip Chowdhury
Society for Applied Studies
