Innovative Strategies to Promote Early Child Development Among Low-income Rural Infants and Preschoolers in India Through Multiple Micronutrient Fortification and Early Learning Opportunities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 834
- 试验地点
- 2
- 主要终点
- Infants: Change in cognitive, language, motor, and socio-emotional development
研究概览
简要总结
Project Grow Smart evaluates the impact fortification with multiple micronutrient powders (MNP) vs. placebo (one vitamin) on child development (primary outcome) and on micronutrient status, growth, and morbidity (secondary outcomes) among young children in rural India (Nalgonda district of Telegana). There is an infant phase and a preschool phase; investigators, study team members, and participants are unaware of whether the fortification is MNP vs. placebo.
The infant phase (enrollment age: 6-14 months) is a 4-cell factorial randomized trial (MNP vs. placebo and early learning vs. routine care), conducted through home visits. Sachets (MNP/placebo) are distributed to be mixed with food. The hypotheses in the infant phase are: 1) MNP leads to better development, growth, and micronutrient status; 2) Early learning leads to better development; 3) Integrated MNP plus early learning leads to better development through both additive and synergistic processes. Developmental evaluations and anthropometric measurements are conducted at baseline, mid-line (6 months), and end-line (12 months). Blood draws for micronutrient status are performed at baseline and endline. Morbidity measures are collected monthly using a morbidity form, modeled after the Demographic and Health Survey.
The preschool phase (enrollment age: 30-48 months) is conducted in Anganwadi Centers (AWC) (preschools). AWC are classified as high or low stimulation, based on an objective observational rating system of the physical environment of the preschools and teacher-child interactions. Preschools are categorized into high/low-quality based on median split, followed by random assignment of MNP/placebo nested within high/low-quality preschools. The hypotheses in the preschool phase are: 1)MNP leads to better development, growth, and micronutrient status; 2) the effect of the MNP on preschoolers' development varies by the quality of the AWC, with stronger effects among preschoolers in high-quality AWCs. The intervention has been modified to coincide with the academic term (September-May). Evaluations are conducted at baseline (September) and end-line (prior to May), with an 8-month intervention period.
详细描述
Project Grow Smart has two phases: an infant phase and a preschool phase. The design of the two phases differs, although both evaluate the impact of fortification with multiple micronutrient powders (MNP) vs. placebo on child development.
In the infant phase, 6-14 month old infants are recruited and randomized into one of four cells to receive: placebo, placebo plus early learning, MNP alone, and MNP plus early learning (integrated intervention). Interventions are delivered through biweekly (twice/month) home visits by Village Level Workers. Families of all infants receive information on iron rich foods.
The preschool phase is conducted in 22 Anganwadi Centers (AWC) (i.e., preschools). AWC quality is assessed, based on a 109-item observation scale, organized into 18 categories, based on two validated scales: Early Childhood Environment Rating Scale-Revised (ECERS-R) and HOME Inventory, modified to rate the quality of learning opportunities and teacher-child interactions. After training and establishing inter-rater reliability, two psychologists spend four hours in each preschool and independently complete the observation. Scores are summed and averaged. Based on a median split, preschools are categorized into high/low-quality with random assignment of MNP/placebo nested within high/low-quality preschools. Classifications are unknown by investigators, study team, or preschools.
The preschool protocol has been modified to ensure that the trial coincides with the academic term (September-May) to avoid losing the oldest children who transfer to private or primary schools. Baseline evaluations are conducted in September and end-line evaluations are conducted prior to May. Mid-line evaluations have been eliminated. The intervention is delivered over 8 months. The MNP/placebo was supplied to preschools in identical packets of 200 grams, including two measuring spoons of 1 and 0.5 grams. Each packet includes a manufacturer-assigned alphabetic code. AWC workers mix the MNP/placebo into the first bites of the preschoolers' mid-day meal. Mothers receive information on iron-rich food.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participating children must be in one of two age groups: infants: 6-14 months or preschoolers: 30-48 months, inclusive, at time of recruitment.
- •Participants must reside in the Nalgonda district of Telengana, India.
- •Preschoolers must attend an Anganwadi Center (preschool) in the Nalgonda district that is participating in Project Grow Smart.
- •Participating caregivers must be at least 18 years of age at the time of recruitment.
排除标准
- •Children with chronic diseases, developmental disabilities, mental retardation, or severe physical handicaps will be excluded
- •Children with severe stunting ( <= -3 standard deviation of length-for-age z-score) or severe anemia (hemoglobin < 7 g/dl) will be excluded and referred to a local hospital for evaluation and intervention, as needed..
研究组 & 干预措施
Infants: MNP
• Infants will receive sachets of multiple micronutrient powder (MNP) vs. placebo.
干预措施: MNP (Dietary Supplement)
Infants: Early Learning
• Infant will receive early learning messages delivered in the home by village level workers vs. routine care.
干预措施: Early Learning (Behavioral)
Infants: No intervention
- Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin).
- Infant phase. Routine care - no early learning intervention
Infants: MNP/Early Learning
- Infants receive the MNP plus early learning intervention by receiving MNP sachets
- Caregivers receive early learning messaged delivered at home biweekly for one year
干预措施: MNP (Dietary Supplement)
Infants: MNP/Early Learning
- Infants receive the MNP plus early learning intervention by receiving MNP sachets
- Caregivers receive early learning messaged delivered at home biweekly for one year
干预措施: Early Learning (Behavioral)
Preschoolers:MNP/High qual preschool
- Preschoolers will receive MNP fortified food in their Anganwadi Centers at the mid-day meal.
- Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.
- Preschools that are classified as high quality preschools.
干预措施: MNP (Dietary Supplement)
Preschoolers:Placebo/High qual preschool
- Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin).
- Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.
- Preschools that are classified as high quality preschools.
Preschoolers:MNP/Low qual preschool
- Preschoolers will receive MNP fortified food in their Anganwadi Centers at the mid-day meal.
- Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.
- Preschools that are classified as low quality preschools.
干预措施: MNP (Dietary Supplement)
Preschoolers:Placebo/Low qual preschool
- Placebo intervention include exposure to a single vitamin (B2 or riboflavin), plus the filler (maltodextrin).
- Preschool quality will be assessed through observations using the Indian-modified ECERS and HOME Inventory for preschools. Using a median split, preschools will be classified as high/low quality. Using a randomization procedure, MNP vs. placebo will be assigned, nested within high/low-quality preschools.
- Preschools that are classified as low quality preschools.
结局指标
主要结局
Infants: Change in cognitive, language, motor, and socio-emotional development
时间窗: Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)
Data on infants' cognitive, language, motor, and socio-emotional development will be collected at baseline, the 6 month follow-up evaluation, and the 12-month follow-up evaluation using the Mullens Scales of Early Learning.
Preschoolers: Change in cognitive, language, motor, and socio-emotional development
时间窗: Baseline and End-Point (8mo post BL)
Data on preschoolers' cognitive, language, motor, and socio-emotional development will be collected at baseline and the 8-month follow-up evaluation using the Mullens Scales of Early Learning.
次要结局
- Preschoolers: Change in weight and height(Baseline and End-Point (8mo post BL))
- Infants: Morbidity(Baseline and once a month (for 12mo post BL))
- Preschoolers: Morbidity(Baseline and once a month (for 8mo post BL))
- Infants: Change in micronutrient Status(Baseline and End-Point (12 mo post-baseline))
- Preschoolers: Change in micronutrient Status(Baseline and End-Point (8mo post BL))
- Infants: Change in weight and height(Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL))
研究者
Maureen Black
Professor
University of Maryland, Baltimore