Project Grow Smart: Intervention Trial of Multiple Micronutrients and Early Learning Among Infants in India

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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..