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

NCT01660958 | Completed DMC

• 1 other identifier: 00048720
• Study Type: interventional
• Target: 834
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Deficiencies; Developmental Delay

Keywords

Micronutrient Deficiencies; Early Child Development; Infant Growth; Iron Deficiency

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (6)

• 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)

• Preschoolers: Change in weight and height

  Baseline and End-Point (8mo post BL)

• Infants: Morbidity

  Baseline and once a month (for 12mo post BL)

Study Arms (8)

Infants: MNP

EXPERIMENTAL

• Infants will receive sachets of multiple micronutrient powder (MNP) vs. placebo.

Dietary Supplement: MNP

Infants: Early Learning

EXPERIMENTAL

• Infant will receive early learning messages delivered in the home by village level workers vs. routine care.

Behavioral: Early Learning

Infants: No intervention

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

EXPERIMENTAL

* Infants receive the MNP plus early learning intervention by receiving MNP sachets * Caregivers receive early learning messaged delivered at home biweekly for one year

Dietary Supplement: MNP; Behavioral: Early Learning

Preschoolers:MNP/High qual preschool

EXPERIMENTAL

* 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.

Dietary Supplement: MNP

Preschoolers:Placebo/High qual preschool

NO INTERVENTION

* 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

EXPERIMENTAL

* 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.

Dietary Supplement: MNP

Preschoolers:Placebo/Low qual preschool

NO INTERVENTION

* 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.

Interventions

MNP DIETARY_SUPPLEMENT

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.

Infants: MNP; Infants: MNP/Early Learning; Preschoolers:MNP/High qual preschool; Preschoolers:MNP/Low qual preschool

Early Learning BEHAVIORAL

• 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.

Also known as: Care for Development

Infants: Early Learning; Infants: MNP/Early Learning

Eligibility Criteria

• Age: 6 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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..

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Indian Council of Medical Research: collaborator
• The Mathile Institute for the Advancement of Human Nutrition: collaborator
• Micronutrient Initiative: collaborator

Study Sites (1)

National Institute of Nutrition

Hyderabad, Andhra Pradesh, 500007, India

Location

Related Publications (1)

• 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.

  PMID: 33880548 DERIVED

MeSH Terms

Conditions

Malnutrition; Learning Disabilities; Iron Deficiencies

Interventions

Growth and Development

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Iron Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physiological Phenomena

Study Officials

• Maureen M Black, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• Madhavan K. Nair, PhD

  NATIONAL INSTITUTE OF NUTRITION

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: * The infant phase is a factorial design. * The preschool phase is a cluster-randomized trial (MNP/placebo nested within high/low-quality preschools).

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: August 9, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

IN (1)