Early Child Development and Nutrition in Guatemala

NCT02302729 | Completed DMC

• 1 other identifier: HP-00061322
• Study Type: interventional
• Target: 1,730
• Locations: 1 country
• Sites: 1

Brief Summary

Over 200 million children under the age of 5 years in low and middle-income countries do not reach their developmental potential, largely due to lack of adequate nutrients and lack of psychosocial stimulation. Stunting (length-for-age \< -2 z-scores) is an indication of chronic undernutrition. Guatemala has the high rates of stunting in the Western Hemisphere (over 40%). This trial examines the effect of providing a micronutrient powder manufactured in Guatemala vs. placebo and an early learning environment vs. no early learning environment on the growth, health, and development of young children in Guatemala.

Conditions

Undernutrition

Keywords

Micronutrient intervention; Responsive feeding intervention; School readiness intervention

Outcome Measures

Primary Outcomes (1)

• Change in cognitive, motor, social-emotional development from baseline to 12 months

  Cognitive and social-emotional assessments

  Baseline, 12 months

Secondary Outcomes (2)

• Change in Growth from baseline to 12 months

  Baseline, 12 months

• Change in micronutrient status from baseline to 12 months

  Baseline, 12 months

Study Arms (4)

Micronutrients No responsive feeding

EXPERIMENTAL

Micronutrient powder and no responsive feeding

Dietary Supplement: Micronutrients

Placebo and Responsive Feeding

PLACEBO COMPARATOR

Placebo (vitamin B2) and Responsive Feeding

Behavioral: Responsive feeding; Dietary Supplement: Placebo

Micronutrients and Responsive caregiving

EXPERIMENTAL

Micronutrients and Responsive feeding intervention

Dietary Supplement: Micronutrients; Behavioral: Responsive feeding

Placebo and No responsive caregiving

PLACEBO COMPARATOR

Placebo and No responsive caregiving

Dietary Supplement: Placebo

Interventions

Micronutrients DIETARY_SUPPLEMENT

Nutrient Quantity Nutrient Quantity Zinc 9 mg Copper 0.3 mg Iron 12.5 mg Vitamin D3 5 mg Folic Acid 160 mcg Vitamin E 5 mg Iodine 90 mcg Calcium 200 mg Vitamin A 250 mg Phosphorus 150 mg Vitamin C 40 mg Magnesium 40 mg Vitamin B12 0.9 mcg Selenium 17 mcg Thiamine 0.5 mg Manganese 0.17 mg Niacin 0.5 mg Biotin 8 mg Riboflavin 6 mg Vitamin B5 1.8 mg Vitamin B6 0.5 mg

Micronutrients No responsive feeding; Micronutrients and Responsive caregiving

Responsive feeding BEHAVIORAL

Strategy Mother ensures that feeding area is set up with infant and mother able to see one another. Mother mirrors the infant's facial expressions to attract the infant's attention. Mother interprets infant's behavior with a positive voice, "Oh, you like the spinach." Mother extends infant's behavior by saying, "Oh the cereal is all gone" and doing a consistent hand signal Mother models eating, makes positive comments in a nurturing tone. Mother offers finger food or use of utensil

Micronutrients and Responsive caregiving; Placebo and Responsive Feeding

Placebo DIETARY_SUPPLEMENT

Riboflavin Vitamin B2

Placebo and No responsive caregiving; Placebo and Responsive Feeding

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child speaks Spanish.
• Child is age 6-12 months or age 36-48 months.
• Child must be undernourished (length and height for age \< -1 z-score).
• Child does not have any obvious health or developmental problems that would interfere with growth, nutrition, or development.
• Child will remain in the area for the subsequent year.
• Parent or legal guardian of the child is age 18 years or older.
• Parent or legal guardian speaks and understands Spanish.
• Parent or legal guardian lives with child in study community.

You may not qualify if:

• Child is not age 6-12 months or 36-48 months.
• Child has severe stunting (length and height for age \< -3 z-scores).
• Child has identified conditions that could interfere with their development and growth.
• Child is severely anemic (hemoglobin \< 7).

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Association for the Study and Prevention of HIV/AIDS: collaborator

Study Sites (1)

APEVIHS (Association for the Prevention and Study of HIV/AIDS)

Retalhuleu, Guatemala

Location

Related Publications (1)

• Unable to connect to PubMed to validate , last attempt on November 19, 2014 at 3:47 PM EST

  BACKGROUND

MeSH Terms

Conditions

Malnutrition

Interventions

Micronutrients

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Maureen M Black, Ph.D.

  Uniersity of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 27, 2014
• Study Start: February 16, 2015
• Primary Completion: December 8, 2015
• Study Completion: December 8, 2015
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

GU (1)