- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02302729
Early Child Development and Nutrition in Guatemala
Professor, Department of Pediatrics, University of Maryland School of Medicine
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Retalhuleu, Guatemala
- APEVIHS (Association for the Prevention and Study of HIV/AIDS)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Micronutrients No responsive feeding
Micronutrient powder and no responsive feeding
|
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 Comparator: Placebo and Responsive Feeding
Placebo (vitamin B2) and 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
Riboflavin Vitamin B2
|
Experimental: Micronutrients and Responsive caregiving
Micronutrients and Responsive feeding intervention
|
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
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 Comparator: Placebo and No responsive caregiving
|
Riboflavin Vitamin B2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognitive, motor, social-emotional development from baseline to 12 months
Time Frame: Baseline, 12 months
|
Cognitive and social-emotional assessments
|
Baseline, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Growth from baseline to 12 months
Time Frame: Baseline, 12 months
|
Weight, length/height
|
Baseline, 12 months
|
Change in micronutrient status from baseline to 12 months
Time Frame: Baseline, 12 months
|
Blood draw
|
Baseline, 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maureen M Black, Ph.D., Uniersity of Maryland, Baltimore
Publications and helpful links
General Publications
- Unable to connect to PubMed to validate , last attempt on November 19, 2014 at 3:47 PM EST
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00061322
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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