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| Name | Class |
|---|---|
| Association for the Study and Prevention of HIV/AIDS | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micronutrients No responsive feeding | Experimental | Micronutrient powder and no responsive feeding |
|
| Placebo and Responsive Feeding | Placebo Comparator | Placebo (vitamin B2) and Responsive Feeding |
|
| Micronutrients and Responsive caregiving | Experimental | Micronutrients and Responsive feeding intervention |
|
| Placebo and No responsive caregiving | Placebo Comparator | Placebo and No responsive caregiving |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive, motor, social-emotional development from baseline to 12 months | Cognitive and social-emotional assessments | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Growth from baseline to 12 months | Weight, length/height | Baseline, 12 months |
| Change in micronutrient status from baseline to 12 months | Blood draw |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maureen M Black, Ph.D. | Uniersity of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APEVIHS (Association for the Prevention and Study of HIV/AIDS) | Retalhuleu | Guatemala |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Unable to connect to PubMed to validate , last attempt on November 19, 2014 at 3:47 PM EST |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018977 | Micronutrients |
| ID | Term |
|---|---|
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
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|
| 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 |
|
| Placebo | Dietary Supplement | Riboflavin Vitamin B2 |
|
| Baseline, 12 months |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |