Early Child Development and Nutrition in Guatemala

NCT ID: NCT02302729

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1730 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-16
• Study Completion Date: 2015-12-08

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.

Detailed Description

The plan is to implement a clustered randomized placebo controlled trial with an infant phase (6-12 months of age) and a preschool phase (36-48 months of age). For the infant phase, the investigators will use ProPAN (Process for the Promotion of Child Feeding) in the development of the evaluation and intervention, with modifications as necessary for the Guatemalan context. ProPAN is a tool developed and distributed by the Pan American Health Organization to develop, implement, and evaluate interventions and programs to improve infant and young child diet and feeding. ProPAN includes four modules:

Module 1: Assessment Module 2: Testing Recipes and Recommendations Module 3: Intervention Module 4: Monitoring and Evaluation

For the preschool phase, the investigators will use an evidence-based school readiness intervention (Little By Little) that has been shown to be effective with Hispanic preschoolers. The intervention will be implemented through the Association for the Prevention and Study of HIV/AIDS who will train and supervise the community health workers. By working directly with a local non-profit organization, the project will be well positioned to inform strategies to scale up the intervention on a community wide basis, if beneficial effects are shown.

The project examines the effects of an integrated intervention that includes both micronutrient powder added to food and responsive feeding for infants or school readiness for preschoolers. The primary aim is to examine how an integrated micronutrients + responsive feeding/school readiness intervention changes the development (primary outcome), growth and micronutrient status (secondary outcomes) of young children. The investigators will focus on infants (6-12 months) when the risk for micronutrient deficiencies is high, as they transition from breast feeding to complementary feeding and the family diet. The investigators will focus on preschoolers (36-48 months) to examine if micronutrients + a school readiness intervention can improve children's school readiness skills. The design includes neighborhood clusters randomized into four groups: 1) micronutrients plus responsive feeding/school readiness 2) micronutrients only, 3) placebo plus responsive feeding/school readiness, and 4) placebo only.

The investigators will test the following hypotheses:

1. Children in the two micronutrients groups have better change from baseline in development (primary outcome), growth and micronutrient status (secondary oitcomes), than children in the two placebo groups.

2. Mothers and children in the two responsive feeding/school readiness groups have better change from baseline measures of child development than those in the two control groups.

3. The impact of the responsive feeding/school readiness intervention is greater in the micronutrient groups than in the placebo groups. Children in the micronutrients plus responsive feeding/school readiness group have better change from baseline in development than children in any of the other three groups.

Conditions

Undernutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Micronutrients No responsive feeding

Micronutrient powder and no responsive feeding

Group Type: EXPERIMENTAL

Micronutrients

Intervention Type: 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

Placebo and Responsive Feeding

Placebo (vitamin B2) and Responsive Feeding

Group Type: PLACEBO_COMPARATOR

Responsive feeding

Intervention Type: 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

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Riboflavin Vitamin B2

Micronutrients and Responsive caregiving

Micronutrients and Responsive feeding intervention

Group Type: EXPERIMENTAL

Micronutrients

Intervention Type: 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

Responsive feeding

Intervention Type: 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

Placebo and No responsive caregiving

Placebo and No responsive caregiving

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Riboflavin Vitamin B2

Interventions

Micronutrients

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

Intervention Type: DIETARY_SUPPLEMENT

Responsive feeding

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

Intervention Type: BEHAVIORAL

Placebo

Riboflavin Vitamin B2

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Association for the Study and Prevention of HIV/AIDS

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Maureen Black

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maureen M Black, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Uniersity of Maryland, Baltimore

Locations

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

Retalhuleu, , Guatemala

Countries

Guatemala

References

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

Reference Type: BACKGROUND

Other Identifiers

HP-00061322

Identifier Type: -

Identifier Source: org_study_id