Project Grow Smart: Intervention Trial of Multiple Micronutrients and Early Learning Among Infants in India
Condition: Nutritional Deficiencies; Developmental Delay
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): MNP; Early Learning
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): The formulation of the multiple micronutrient powder (MNP) was based on low micronutrient intake, low bioavailability of iron and zinc in the Indian diet, and current World Health Organization (WHO)and Indian recommendations regarding fortification and age-specific nutrient requirements. The MNP formulations were produced by a certified company in India and include: Iron, Vitamin A, Vitamin C, Folic Acid, Zinc, Vitamin B12 Vitamin B2, plus filler (maltodextrin). Placebo included riboflavin and maltodextrin.; • Infant will benefit from interventions that are based on responsive parenting, whereby caregivers respond to children's cues, provide opportunities for exploration, and engage in nurturant and reciprocal communication.
Other intervention name(s): Care for Development
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: The infant phase is a factorial design.
The preschool phase is a cluster-randomized trial (MNP/placebo nested within high/low-quality preschools).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Micronutrient Deficiencies; Early Child Development; Infant Growth; Iron Deficiency