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

Developmental Delay Clinical Trial

— GrowSmart  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660958
• Other study ID #: 00048720
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 834
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 48 Months

Eligibility

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..

Related Conditions & MeSH terms

• Developmental Delay
• Malnutrition
• Nutritional Deficiencies

Intervention

Dietary Supplement:
• MNP
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.

Behavioral:
• Early Learning
• 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.

Locations

Country	Name	City	State
India	National Institute of Nutrition	Hyderabad	Andhra Pradesh

Sponsors (4)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	Indian Council of Medical Research, Micronutrient Initiative, The Mathile Institute for the Advancement of Human Nutrition

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infants: Change in cognitive, language, motor, and socio-emotional development	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.	Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)
Primary	Preschoolers: Change in cognitive, language, motor, and socio-emotional development	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.	Baseline and End-Point (8mo post BL)
Secondary	Infants: Change in micronutrient Status	Data on infants' micronutrient status (serum ferritin, transferrin receptor, serum zinc, C-reactive protein) and hemoglobin will be collected at baseline and the 12-month follow-up evaluation.	Baseline and End-Point (12 mo post-baseline)
Secondary	Preschoolers: Change in micronutrient Status	Data on preschoolers' micronutrient status (serum ferritin, transferrin receptor, serum zinc, C-reactive protein) and hemoglobin will be collected at baseline and the 8-month follow-up evaluation.	Baseline and End-Point (8mo post BL)
Secondary	Infants: Change in weight and height	Data on infants' weight and height will be collected at baseline, the 6 month follow-up evaluation, and the 12-month follow-up evaluation	Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL)
Secondary	Preschoolers: Change in weight and height	Data on preschoolers' weight and height will be collected at baseline and the 8-month follow-up evaluation	Baseline and End-Point (8mo post BL)
Secondary	Infants: Morbidity	Morbidity measures (acute respiratory infection and diarrhea) are conducted monthly using a morbidity form, modeled after the Demographic and Health Survey.	Baseline and once a month (for 12mo post BL)
Secondary	Preschoolers: Morbidity	Morbidity measures (acute respiratory infection and diarrhea) are conducted monthly using a morbidity form, modeled after the Demographic and Health Survey.	Baseline and once a month (for 8mo post BL)