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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Maryland.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Indian Council of Medical Research
The Mathile Institute for the Advancement of Human Nutrition
Micronutrient Initiative
Information provided by (Responsible Party):
Maureen Black, University of Maryland
ClinicalTrials.gov Identifier:
NCT01660958
First received: July 26, 2012
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

Project Grow Smart evaluates the impact of a 12-month intervention of micronutrient-fortified food and an early learning intervention on young children's cognitive ability. There is an infancy phase and a preschool phase.

The infant phase is conducted through home visits - micronutrient sachets are distributed to be mixed with food. The preschool phase is conducted in Anganwadi Centers. Hypothesis #1 is that infants who receive both the micronutrients and the early learning intervention will have better scores on measures of child development than children who receive neither. Children who receive one of the two interventions will have intermediate scores. Hypothesis #2 is that preschoolers in Anganwadi Centers that receive the micronutrient-enriched food wll have better scores on measures of child development than children in Anganwadi Centers who do not.

The preschool phase is conducted in Anganwadi Centers (AWC), which are like preschools. Preschoolers age 36-48 months are recruited. AWC are classified as high or low stimulation, based on a rating system (Early Childhood and Childcare Environmental Rating Scale, ECERS). AWC are randomized into 2 cells: 1) multiple micronutrient-fortified food or 2) placebo-fortified food. Preschoolers receive the food in the AWC; their mothers receive information on iron-rich food. For both phases, evaluations are conducted at recruitment and after 6 and 12 months and focus on changes in the children's cognitive performance and micronutrient (iron) status.

The investigators hypothesize that innovative multiple micronutrient (MN) fortification strategies for infants and preschoolers combined with early learning opportunities will impact children's micronutrient status, growth and development in Nalgonda district of Andhra Pradesh, India.


Condition Intervention Phase
Nutritional Deficiencies
Developmental Delay
Dietary Supplement: Micronutrient Intervention
Behavioral: Early Learning
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Change in cognitive, language, motor, and socio-emotional development [ Time Frame: Baseline, Mid-Point (6mo post BL), and End-Point (12mo post BL) ] [ Designated as safety issue: No ]
    Data on children's 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.


Secondary Outcome Measures:
  • Change in micronutrient Status [ Time Frame: Baseline and End-Point (12 mo post-baseline) ] [ Designated as safety issue: No ]
    Data on children's micronutrient status (serum ferritin, transferrin receptor, serum zinc, C-reactive protein) will be collected at baseline and the 12-month follow-up evaluation. Hemoglobin will be also collected at baseline, 6mo post-baseline, and 12 mo post-baseline


Other Outcome Measures:
  • Change in weight and height [ Time Frame: Baseline, Mid-Point (6mo post-BL), and End-Point (12 mo post-BL) ] [ Designated as safety issue: No ]
    Data on children's weight and height will be collected at baseline, the 6 month follow-up evaluation, and the 12-month follow-up evaluation


Estimated Enrollment: 720
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Micronutrient
Micronutrient Intervention: Infants will receive sachets of micronutrients (MN). Preschoolers will receive MN fortified food in their Anganwadi Centers
Dietary Supplement: Micronutrient Intervention
The formulation of the mutiple micronutrient products was determined by considering the level of MN deficiency among young children in India, the Indian RDA for each MN by age, and data from efficacy trials on the dose of MN required for changes in cognition. The MN formulations were produced by a certified company in India and include: Iron, Vitamin A,Vitamin C,Folic Acid,Zinc, Vitamin B12 Vitamin B2.
Experimental: Early Learning Opportunities (MCPC)

Infant will receive early learning messages delivered in the home by village level workers

Preschools will be classified by their quality using the Indian-modified ECERS. Similar centers will be yoked and randomized into intervention/placebo to ensure that the quality of the preschool is stratified within study arm.

Behavioral: Early Learning
In the preschool phase, we will recruit 12 Anganwadi Centers (Preschools). They will be scored to determine their quality (in terms of early stimulation and learning opportunities) using the Indian modified Early Childhood Environment Rating Scale (ECERS) and then randomized by quality rating into MN intervention or placebo
Other Name: Care for Development
Placebo Comparator: Placebo
Placebo intervention include exposure to a single vitamin and nutrition education around iron-rich foods.
Experimental: Micronutrient/Early Learning
Micronutrient/Early Learning Intervention. Infants receive the micronutrient plus early learning intervention by receiving microntrient sachets and their caregivers receive early learning messaged delivered at home biweekly for one year
Dietary Supplement: Micronutrient Intervention
The formulation of the mutiple micronutrient products was determined by considering the level of MN deficiency among young children in India, the Indian RDA for each MN by age, and data from efficacy trials on the dose of MN required for changes in cognition. The MN formulations were produced by a certified company in India and include: Iron, Vitamin A,Vitamin C,Folic Acid,Zinc, Vitamin B12 Vitamin B2.
Behavioral: Early Learning
In the preschool phase, we will recruit 12 Anganwadi Centers (Preschools). They will be scored to determine their quality (in terms of early stimulation and learning opportunities) using the Indian modified Early Childhood Environment Rating Scale (ECERS) and then randomized by quality rating into MN intervention or placebo
Other Name: Care for Development

Detailed Description:

Project Grow Smart evaluates the impact of a 12-month intervention of micronutrient-fortified food and an early learning intervention on young children's cognitive ability. There is an infancy phase and a preschool phase.

In the infant phase, 6-12 month old infants are recruited and randomized into one of four cells to receive: 1) sachets of multiple micronutrients or sachets of placebo (vitamins) to be added to the infant's food and 2) an early learning intervention delivered in the home or control (no early learning intervention). Families of all infants will receive information on iron rich foods.

The preschool phase is conducted in Anganwadi Centers (AWC), which are like preschools. Preschoolers age 36-48 months are recruited. AWC are classified as high or low stimulation, based on a rating system (Early Childhood and Childcare Environmental Rating Scale, ECERS). AWC are randomized into 2 cells: 1) multiple micronutrient-fortified food or 2) placebo-fortified food. Preschoolers receive the food in the AWC; their mothers receive information on iron-rich food. For both phases, evaluations are conducted at recruitment and after 6 and 12 months and focus on changes in the children's cognitive performance and micronutrient (iron) status.

The investigators hypothesize that innovative multiple micronutrient (MN) fortification strategies for infants and preschoolers combined with early learning opportunities will impact children's micronutrient status, growth and development in Nalgonda district of Andhra Pradesh, India.

  Eligibility

Ages Eligible for Study:   12 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participating children must be in one of two age groups: 6-12 months or 36-48 months, inclusive, at time of recruitment.
  • Participants must reside in the Nalgonda district of Andhra Pradesh, India.
  • Participating children 36 to 48 months of age 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 signs of clinical undernourishment (wasting <= -3 SD wt/lgth; anemia < 7 g/dl) will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01660958

Contacts
Contact: Maureen M Black, PhD 410-706-2136 mblack@peds.umaryalnd.edu
Contact: Madhavan K. Nair, PhD 040-27018909 ext 269 nairthayil@hotmail.com

Locations
India
National Institute of Nutrition Recruiting
Hyderabad, Andhra Pradesh, India, 500007
Contact: Madhavan K Nair, PhD    040-27018909 ext 269    nairthayil@hotmail.com   
Contact: Sylvia Fernandez, PhD       syl_vijay@yahoo.com   
Principal Investigator: Madhavan K Nair, PhD         
Sub-Investigator: Sylvia Fernandez, PhD         
Sponsors and Collaborators
University of Maryland
Indian Council of Medical Research
The Mathile Institute for the Advancement of Human Nutrition
Micronutrient Initiative
Investigators
Principal Investigator: Maureen M Black, PhD University of Maryland
Principal Investigator: Madhavan K. Nair, PhD NATIONAL INSTITUTE OF NUTRITION
  More Information

No publications provided

Responsible Party: Maureen Black, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT01660958     History of Changes
Other Study ID Numbers: 00048720
Study First Received: July 26, 2012
Last Updated: August 6, 2012
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Maryland:
Micronutrient Deficiencies
Early Child Development
Infant Growth
Iron Deficiency

Additional relevant MeSH terms:
Nutrition Disorders
Malnutrition
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014