Clinical trial NCT01660958: Project Grow Smart: Intervention Trial of Multiple Micronutrients and Early Learning Among Infants in India
Official title: Innovative Strategies to Promote Early Child Development Among Low-income Rural Infants and Preschoolers in India Through Multiple Micronutrient Fortification and Early Learning Opportunities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Deficiencies
Developmental Delay
Keywords: Micronutrient Deficiencies
Early Child Development
Infant Growth
Iron Deficiency
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Indian Council of Medical Research
name: The Mathile Institute for the Advancement of Human Nutrition
name: Micronutrient Initiative
First posted: 2012-08-09
Enrollment: 834
Sex: ALL
Minimum age (years): 6
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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).
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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..

Primary outcomes:
measure: Infants: Change in cognitive, language, motor, and socio-emotional development
timeFrame: Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)
measure: Preschoolers: Change in cognitive, language, motor, and socio-emotional development
timeFrame: Baseline and End-Point (8mo post BL)
Secondary outcomes:
measure: Infants: Change in micronutrient Status
timeFrame: Baseline and End-Point (12 mo post-baseline)
measure: Preschoolers: Change in micronutrient Status
timeFrame: Baseline and End-Point (8mo post BL)
measure: Infants: Change in weight and height
timeFrame: Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)
measure: Preschoolers: Change in weight and height
timeFrame: Baseline and End-Point (8mo post BL)
measure: Infants: Morbidity
timeFrame: Baseline and once a month (for 12mo post BL)
measure: Preschoolers: Morbidity
timeFrame: Baseline and once a month (for 8mo post BL)
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: National Institute of Nutrition
state: Andhra Pradesh
Study officials:
affiliation: University of Maryland, Baltimore
name: Maureen M Black, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NATIONAL INSTITUTE OF NUTRITION
name: Madhavan K. Nair, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Black MM, Fernandez-Rao S, Nair KM, Balakrishna N, Tilton N, Radhakrishna KV, Ravinder P, Harding KB, Reinhart G, Yimgang DP, Hurley KM. A Randomized Multiple Micronutrient Powder Point-of-Use Fortification Trial Implemented in Indian Preschools Increases Expressive Language and Reduces Anemia and Iron Deficiency. J Nutr. 2021 Jul 1;151(7):2029-2042. doi: 10.1093/jn/nxab066.