CTRI/2025/03/083577尚未招募不适用
Evaluation Of LEAD (Learn, Eat And Develop) Intervention for Mothers to Improve Early Childhood Development and Reduce Stunting in Infants of Urban Slums of Nagpur, Wardha and Belagavi districts in India.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,636
- 试验地点
- 3
- 主要终点
- 1. Early Childhood Development using ASQ and BSID
研究概览
简要总结
This is a community-based, cluster randomized trial for evaluation of effectiveness of the “The
Learn, Eat, And Develop” or LEAD intervention in 1,636 mother baby dyads in 60 cluster from
urban slums within Nagpur, Wardha and Belagavi cities of India. The primary outcome measures
are early childhood development and stunting at 18 months. Secondary outcomes include
measures related to antenatal/postnatal care, maternal nutrition, hygiene, fetal/baby indicators,
AWW/BalSakhi indicators, and process indicators at various timepoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •i) Pregnant women more than 18 years of age, pregnancy confirmed by UPT and/or USG ii) Gestational age within 20 weeks confirmed by LMP and/or USG, iii) Planning to reside in the same cluster through delivery till their infant is 18 months of age iv) Willing to participate and provide informed consent.
排除标准
- •i) HIV positive cases ii) Those who do not consent.
结局指标
主要结局
1. Early Childhood Development using ASQ and BSID
时间窗: End point
scores and Stunting
时间窗: End point
次要结局
- reastfeeding (Timely Initiation and Exclusive Breastfeeding),(at birth, 3 months, 6 months 12 months, 15 months & 18 months of age)
- Knowledge and performance of AWW and BalSakhis,(At baseline and Endline)
- Antenatal and postnatal visits events (healthcare seeking behaviour, good ANC(practices, medication (Fe, Ca)& Immunization compliance etc))
- Infant outcomes (Mortality, Morbidity, Hospitalization, Immunization status),(at 12 months of age)
- Nutrition, semi-solid or soft foods/ Nutrient adequacy,(at birth, 3 months, 6 months 12)
- Wasting,(at 18 months of age)
- Fetal loss(at end of pregnancy)
- Preterm birth, Low Birth Weight, Newborn complications(At delivery)
- Maternal nutrient(2nd & 3rd Trimester of pregnancy)
- Fidelity, dose(completeness of exposure) reach, satisfaction and contextual(assessment,)
研究者
研究点 (3)
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